## Protocol Section
### Identification Module
**NCT ID:** NCT04779879

**Acronym:** COMET-PEAK

**Brief Title:** Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19

**Official Title:** A Multicenter, Randomized, Double-Blind, Parallel Group Phase II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Second Generation VIR-7831 Material in Non-Hospitalized Participants With Mild to Moderate Coronavirus Disease 2019 (COVID-19)

#### Organization Study ID Info
**ID:** VIR-7831-5006
#### Organization
**Class:** INDUSTRY
**Full Name:** Vir Biotechnology, Inc.
#### Secondary ID Infos
**Domain:** GlaxoSmithKline
**ID:** GSK Study 216912
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2022-04-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-05-03

**Type:** ACTUAL

**Last Update Submit Date:** 2023-04-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-08-20

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2022-11-10

**Type:** ACTUAL

**Results First Submit Date:** 2022-08-24

**Results First Submit QC Date:** 2022-10-13

#### Start Date
**Date:** 2021-02-18

**Type:** ACTUAL

**Status Verified Date:** 2023-04

#### Study First Post Date
**Date:** 2021-03-03
**Type:** ACTUAL
**Study First Submit Date:** 2021-03-01
**Study First Submit QC Date:** 2021-03-01
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** GlaxoSmithKline

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Vir Biotechnology, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This is a phase 2 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 (Sotrovimab) Generation 1 (Gen1) or VIR-7831 (Sotrovimab) Generation 2 (Gen2) and will be assessed for safety, tolerability, and pharmacokinetics.

### Conditions Module

**Conditions:**

- Covid19

**Keywords:**

- SARS-CoV-2

- coronavirus

- coronavirus disease 2019

- COVID-19

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Masking Description:** Part A is double-blinded. Parts B and C are open label.

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 354

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Part A (double-blinded) participants will be randomized to receive 500 mg of an IV infusion of Sotrovimab Gen 1 material or 500 mg of an IV infusion of VIR-7831 Gen 2 material

**Intervention Names:**

- Biological: Sotrovimab (Gen1)

- Biological: Sotrovimab (Gen2)

**Label:** Sotrovimab (Gen1)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Part B (open-label) participants will be randomized to receive 500 mg of Sotrovimab Gen2 material by IV infusion or by IM injection

Part C (open-label) participants will be randomized to receive 500 mg of Sotrovimab Gen2 material by IV infusion or 250 mg by IM injection

**Intervention Names:**

- Biological: Sotrovimab (Gen2)

**Label:** Sotrovimab (Gen2)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Sotrovimab (Gen1)

**Description:** Participants will be randomized to receive an IV infusion of Sotrovimab Gen 1 material

**Name:** Sotrovimab (Gen1)

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Sotrovimab (Gen2)

**Description:** Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion or by IM injection

**Name:** Sotrovimab (Gen2)

**Type:** BIOLOGICAL

#### Intervention 3

**Arm Group Labels:**

- Sotrovimab (Gen1)

**Description:** Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion

**Name:** Sotrovimab (Gen2)

**Type:** BIOLOGICAL

### Outcomes Module

#### Other Outcomes

**Description:** Number of participants with presence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.

**Measure:** Part A: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831

**Time Frame:** Up to Day 28

**Description:** Number of participants with presence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.

**Measure:** Part B: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831

**Time Frame:** Up to Day 28

**Description:** Number of participants with presence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.

**Measure:** Part C: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831

**Time Frame:** Up to Day 28

**Description:** Number of participants with emergence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.

**Measure:** Part A: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831

**Time Frame:** Up to Day 28

**Description:** Number of participants with emergence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.

**Measure:** Part B: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831

**Time Frame:** Up to Day 28

**Description:** Number of participants with emergence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.

**Measure:** Part C: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831

**Time Frame:** Up to Day 28

**Description:** Number of participants with the presence of anti-VIR-7831 antibody was planned to be evaluated. The results for this outcome measure will never be posted.

**Measure:** Part A: Number of Participants With the Presence of Anti-VIR-7831 Antibody

**Time Frame:** Up to Week 24

**Description:** Number of participants with the presence of anti-VIR-7831 antibody was planned to be evaluated. The results for this outcome measure will never be posted.

**Measure:** Part B: Number of Participants With the Presence of Anti-VIR-7831 Antibody

**Time Frame:** Up to Week 24

**Description:** Number of participants with the presence of anti-VIR-7831 antibody was planned to be evaluated. The results for this outcome measure will never be posted.

**Measure:** Part C: Number of Participants With the Presence of Anti-VIR-7831 Antibody

**Time Frame:** Up to Week 24

**Description:** Serum samples were planned to be collected for the determination of anti-drug antibody using a validated electrochemiluminescent (ECL) immunoassay. The results for this outcome measure will never be posted.

**Measure:** Part A: Titers of Anti-drug Antibody to VIR-7831

**Time Frame:** Up to Week 24

**Description:** Serum samples were planned to be collected for the determination of anti-drug antibody using a validated ECL immunoassay. The results for this outcome measure will never be posted.

**Measure:** Part B: Titers of Anti-drug Antibody to VIR-7831

**Time Frame:** Up to Week 24

**Description:** Serum samples were planned to be collected for the determination of anti-drug antibody using a validated ECL immunoassay. The results for this outcome measure will never be posted.

**Measure:** Part C: Titers of Anti-drug Antibody to VIR-7831

**Time Frame:** Up to Week 24

**Description:** Number of participants with the presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.

**Measure:** Part A: Number of Participants With the Presence of Anti-nucleocapsid (Anti-N), Anti-spike (Anti-S) and Anti-Receptor Binding Domain (Anti-RBD) SARS-CoV-2 Antibodies at Baseline

**Time Frame:** Baseline (Day 1)

**Description:** Number of participants with the presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.

**Measure:** Part B: Number of Participants With the Presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline

**Time Frame:** Baseline (Day 1)

**Description:** Number of participants with the presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.

**Measure:** Part C: Number of Participants With the Presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline

**Time Frame:** Baseline (Day 1)

**Description:** Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.

**Measure:** Part A: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline

**Time Frame:** Baseline (Day 1)

**Description:** Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.

**Measure:** Part B: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline

**Time Frame:** Baseline (Day 1)

**Description:** Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.

**Measure:** Part C: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline

**Time Frame:** Baseline (Day 1)

**Description:** Number of participants with the presence of Anti-N SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.

**Measure:** Part A: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at Day 29

**Time Frame:** Day 29

**Description:** Number of participants with the presence of Anti-N SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.

**Measure:** Part B: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at Day 29

**Time Frame:** Day 29

**Description:** Number of participants with the presence of Anti-N SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.

**Measure:** Part C: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at Day 29

**Time Frame:** Day 29

**Description:** Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.

**Measure:** Part A: Titers of Anti-N SARS-CoV-2 Antibodies at Day 29

**Time Frame:** Day 29

**Description:** Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.

**Measure:** Part B: Titers of Anti-N SARS-CoV-2 Antibodies at Day 29

**Time Frame:** Day 29

**Description:** Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.

**Measure:** Part C: Titers of Anti-N SARS-CoV-2 Antibodies at Day 29

**Time Frame:** Day 29

#### Primary Outcomes

**Description:** An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.

**Measure:** Part A: Number of Participants With All Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Day 29

**Time Frame:** Up to Day 29

**Description:** An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were infusion-related reactions (IRR) including hypersensitivity, events related to antibody-dependent enhancement, and events related to immunogenicity.

**Measure:** Part A: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29

**Time Frame:** Up to Day 29

**Description:** Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented.

**Measure:** Part A: Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) Findings Through Day 29

**Time Frame:** Up to Day 29

**Description:** AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).

**Measure:** Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29

**Time Frame:** Up to Day 29

**Description:** AUC of SARS-CoV-2 viral load was measured by Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from Day 1 to Day 8 in nasopharyngeal (NP) swab samples. Analysis was performed using an Analysis of covariance (ANCOVA) model with covariates of treatment and Baseline logarithm (base 10) viral load.

**Measure:** Part B: Mean Area Under the Curve (AUC) of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Viral Load From Day 1 to Day 8 (AUCD1-8)

**Time Frame:** Day 1 to Day 8

**Description:** AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 8 in NP swab samples. Analysis was performed using an ANCOVA model with covariates of treatment, and Baseline logarithm (base10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).

**Measure:** Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 8 (AUCD1-8)

**Time Frame:** Day 1 to Day 8

#### Secondary Outcomes

**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Adverse events which were not Serious were considered as Non-Serious adverse events.

**Measure:** Part A: Number of Participants With Non-Serious AEs Through Week 12

**Time Frame:** Up to Week 12

**Description:** A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.

**Measure:** Part A: Number of Participants With SAEs Through Week 24

**Time Frame:** Up to Week 24

**Description:** An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs are infusion-related reactions (IRR) including hypersensitivity, events related to antibody-dependent enhancement, and events related to immunogenicity.

**Measure:** Part A: Number of Participants With AESI Through Week 24

**Time Frame:** Up to Week 24

**Description:** Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented.

**Measure:** Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points

**Time Frame:** Days 1, 5, 11 and 85 (Week 12)

**Description:** AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).

**Measure:** Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Week 24

**Time Frame:** Up to Week 24

**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before. Adverse events include both Serious and Other Adverse Events.

**Measure:** Part B: Number of Participants With All AEs and SAEs Through Day 29

**Time Frame:** Up to Day 29

**Description:** An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were infusion/injection-related reactions (IRR) including hypersensitivity; injection site reactions (ISRs); events related to antibody-dependent enhancement; events related to immunogenicity.

**Measure:** Part B: Number of Participants With AESI Through Day 29

**Time Frame:** Up to Day 29

**Description:** Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented.

**Measure:** Part B: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29

**Time Frame:** Up to Day 29

**Description:** AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).

**Measure:** Part B: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29

**Time Frame:** Up to Day 29

**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before. Adverse events include both Serious and Other Adverse Events.

**Measure:** Part C: Number of Participants With All AEs and SAEs Through Day 29

**Time Frame:** Up to Day 29

**Description:** An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were infusion/injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); events related to antibody-dependent enhancement, and events related to immunogenicity.

**Measure:** Part C: Number of Participants With AESI Through Day 29

**Time Frame:** Up to Day 29

**Description:** Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented.

**Measure:** Part C: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29

**Time Frame:** Up to Day 29

**Description:** AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).

**Measure:** Part C: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29

**Time Frame:** Up to Day 29

**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

**Measure:** Part B: Number of Participants With Non-Serious AEs Through Week 12

**Time Frame:** Up to Week 12

**Description:** A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.

**Measure:** Part B: Number of Participants With SAEs Through Week 36

**Time Frame:** Up to Week 36

**Description:** An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs are infusion/injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); events related to antibody-dependent enhancement, and events related to immunogenicity.

**Measure:** Part B: Number of Participants With AESI Through Week 36

**Time Frame:** up to Week 36

**Description:** Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented.

**Measure:** Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points

**Time Frame:** Days 1, 5, 11 and 85 (Week 12)

**Description:** AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).

**Measure:** Part B: Number of Participants With Disease Progression Events Through Week 36

**Time Frame:** Up to Week 36

**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

**Measure:** Part C: Number of Participants With Non-Serious AEs Through Week 12

**Time Frame:** Up to Week 12

**Description:** A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.

**Measure:** Part C: Number of Participants With SAEs Through Week 36

**Time Frame:** Up to Week 36

**Description:** An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs are infusion/injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); events related to antibody-dependent enhancement, and events related to immunogenicity.

**Measure:** Part C: Number of Participants With AESI Through Week 36

**Time Frame:** Up to Week 36

**Description:** Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented.

**Measure:** Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points

**Time Frame:** Days 1, 5, 11 and 85 (Week 12)

**Description:** AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).

**Measure:** Part C: Number of Participants With Disease Progression Events Through Week 36

**Time Frame:** Up to Week 36

**Description:** SARS-CoV-2 viral load was based on saliva and nasal mid-turbinate swab samples and was measured by qRT-PCR. Baseline log10 viral load was defined as the non-missing assessment taken at Day 1 excluding the NEG and \<2.08 results. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

**Measure:** Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load

**Time Frame:** Baseline, Days 2, 5, 8, 11, 15, 22 and 29

**Description:** Viral load was based on nasopharyngeal swab samples and was measured by qRT-PCR. Baseline log10 viral load was defined as the non-missing assessment taken at Day 1 excluding the "NEG" and "\<2.08" results. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

**Measure:** Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples

**Time Frame:** Baseline, Days 2, 3, 5, 8, 11, 15, 22 and 29

**Description:** Viral load was based on nasopharyngeal swab samples and was measured by qRT-PCR. Baseline log10 viral load was defined as the non-missing assessment taken at Day 1 excluding the "NEG" and "\<2.08" results. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

**Measure:** Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples

**Time Frame:** Baseline, Days 2, 3, 5, 8, 11, 15, 22 and 29

**Description:** Viral load was measured by qRT-PCR from nasopharyngeal swab samples. Viral load (log10 copies/mL) values recorded as negative were considered as undetectable viral load. Percentage of participants with undetectable viral load have been presented. Percentage values are rounded off.

**Measure:** Part B: Percentage of Participants With Undetectable Viral Load

**Time Frame:** Days 2, 3, 5, 8, 11, 15, 22 and 29

**Description:** Viral load was measured by qRT-PCR from nasopharyngeal swab samples. Viral load (log10 copies/mL) values recorded as negative were considered as undetectable viral load. Percentage of participants with undetectable viral load have been presented. Percentage values are rounded off.

**Measure:** Part C: Percentage of Participants With Undetectable Viral Load

**Time Frame:** Days 2, 3, 5, 8, 11, 15, 22 and 29

**Description:** AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 5. Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.

**Measure:** Part B: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5)

**Time Frame:** Day 1 to Day 5

**Description:** AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 11. Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.

**Measure:** Part B: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11)

**Time Frame:** Day 1 to Day 11

**Description:** AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 5. Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).

**Measure:** Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5)

**Time Frame:** Day 1 to Day 5

**Description:** AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 11. Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).

**Measure:** Part C: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11)

**Time Frame:** Day 1 to Day 11

**Description:** Percentage of participants with a persistently high viral load were categorized as \>=4.1 log10 copies/mL and \<4.1 log10 copies/mL. Percentage of participants with a persistently high viral load at Day 8 was assessed via qRT-PCR in nasopharyngeal swab samples. Percentage of participants with a persistently high viral load at Day 8 has been presented. Percentage values are rounded off.

**Measure:** Part B: Percentage of Participants With a Persistently High Viral Load at Day 8

**Time Frame:** Day 8

**Description:** Percentage of participants with a persistently high viral load were categorized as \>=4.1 log10 copies/mL and \<4.1 log10 copies/mL. Percentage of participants with a persistently high viral load at Day 8 was assessed via qRT-PCR in nasopharyngeal swab samples. Percentage of participants with a persistently high viral load at Day 8 has been presented. Percentage values are rounded off.

**Measure:** Part C: Percentage of Participants With a Persistently High Viral Load at Day 8

**Time Frame:** Day 8

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part A: Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: Cmax of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: Cmax of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: Cmax of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: Cmax of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part A: Concentration at Last Quantifiable Time-point (Clast) of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: Clast of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: Clast of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: Clast of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: Clast of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part A: Time to Reach Cmax (Tmax) of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: Tmax of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: Tmax of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: Tmax of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: Tmax of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part A: Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: Tlast of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: Tlast of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: Tlast of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: Tlast of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part A: AUC From Day 1 to 29 (AUCD1-29) of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: AUCD1-29 of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: AUCD1-29 of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: AUCD1-29 of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: AUCD1-29 of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part A: Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUC[0-inf]) of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: AUC(0-inf) of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: AUC(0-inf) of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: AUC(0-inf) of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: AUC(0-inf) of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part A: Area Under the Curve From the Time of Dosing to the Time of the Last Measurable (Positive) Concentration (AUClast) of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: AUClast of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: AUClast of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: AUClast of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: AUClast of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part A: Percentage of AUC(Infinity) Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: %AUCexp of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: %AUCexp of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: %AUCexp of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: %AUCexp of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part A: Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: t1/2 of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: t1/2 of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: t1/2 of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: t1/2 of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part A: Apparent Volume of Distribution During the Elimination Phase Following Intravascular Administrtion (Vz) of VIR-7831

**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: Vz of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: Apparent Volume of Distribution During the Elimination Phase Following Extravascular Administration (Vz/F) of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: Vz of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: Vz/F of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part A: Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: Vss of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: Vss of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part A: Clearance (CL) of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: CL of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part B: Apparent Clearance (CL/F) of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: CL of VIR-7831 After IV Administration

**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Part C: CL/F of VIR-7831 After IM Administration

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Dose-normalized least square geometric mean ratio of AUCinf was derived based on collected assessments up to 169 (+/-7 days) for Part B- Sotrovimab Gen2: 500 mg IV arm, and up to 169 (+/-18 days) for Part C- Sotrovimab Gen2: 500 mg IV arm.

**Measure:** Dose-normalized Least Square Geometric Mean Ratio of AUCinf for VIR-7831 Gen2 Between the Three Dose Levels (250 mg IM in Part C, 500 mg IM in Part B and 500 mg IV in Parts B and C)

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Dose-normalized Least Square Geometric Mean Ratio of AUCinf for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B)

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Dose-normalized Least Square Geometric Mean Ratio of AUClast for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B)

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Dose-normalized Least Square Geometric Mean Ratio of AUCD1-D29 for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B)

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)

**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

**Measure:** Dose-normalized Least Square Geometric Mean Ratio of Cmax for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B)

**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* For Part A, participants must be aged 18 years or older at the time of obtaining informed consent
* For Parts B and C, participants must be aged between 18 years and 69 years old at the time of obtaining informed consent
* Participants who have a positive SARS-CoV-2 test result ≤7 days prior to enrollment and oxygen saturation ≥94% on room air and have COVID-19 symptoms and ≤7 days from onset of symptoms

Exclusion Criteria:

* Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours
* Symptoms consistent with severe COVID-19
* Participants who, in the judgement of the investigator are likely to die in the next 7 days.
* Severely immunocompromised participants
* For Parts A and B, prior receipt of a SARS-CoV-2 vaccine at any time prior to enrollment (vaccination with an authorized or approved SARS-CoV-2 vaccine will not be allowed for 90 days after dosing)
* For Parts B and C, conditions that would prohibit receipt of IM injections in the investigator's opinion
* For Parts A, B and C, receipt of any vaccine within 48 hours prior to enrollment (vaccination with an authorized or approved SARS-CoV-2 vaccine will not be allowed for 90 days after dosing)

**Maximum Age:** 69 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Anniston

**Country:** United States

**Facility:** Investigative Site

**State:** Alabama

**Zip:** 36207

**Location 2:**

**City:** Bakersfield

**Country:** United States

**Facility:** Investigative Site

**State:** California

**Zip:** 93301

**Location 3:**

**City:** Northridge

**Country:** United States

**Facility:** Investigative Site

**State:** California

**Zip:** 91325

**Location 4:**

**City:** Fort Pierce

**Country:** United States

**Facility:** Investigative Site

**State:** Florida

**Zip:** 34982

**Location 5:**

**City:** Gainesville

**Country:** United States

**Facility:** Investigative Site

**State:** Florida

**Zip:** 32607

**Location 6:**

**City:** Hialeah

**Country:** United States

**Facility:** Investigative Site

**State:** Florida

**Zip:** 33016

**Location 7:**

**City:** Miami

**Country:** United States

**Facility:** Investigative Site

**State:** Florida

**Zip:** 33125

**Location 8:**

**City:** Miami

**Country:** United States

**Facility:** Investigative Site

**State:** Florida

**Zip:** 33135

**Location 9:**

**City:** Miami

**Country:** United States

**Facility:** Investigative Site

**State:** Florida

**Zip:** 33155

**Location 10:**

**City:** Miami

**Country:** United States

**Facility:** Investigative Site

**State:** Florida

**Zip:** 33176

**Location 11:**

**City:** Orlando

**Country:** United States

**Facility:** Investigative Site

**State:** Florida

**Zip:** 32803

**Location 12:**

**City:** Pembroke Pines

**Country:** United States

**Facility:** Investigative Site

**State:** Florida

**Zip:** 33024

**Location 13:**

**City:** Tampa

**Country:** United States

**Facility:** Investigative Site

**State:** Florida

**Zip:** 33614

**Location 14:**

**City:** Columbus

**Country:** United States

**Facility:** Investigative Site

**State:** Georgia

**Zip:** 31904

**Location 15:**

**City:** Winfield

**Country:** United States

**Facility:** Investigative Site

**State:** Illinois

**Zip:** 60190

**Location 16:**

**City:** Rockville

**Country:** United States

**Facility:** Investigative Site

**State:** Maryland

**Zip:** 20850

**Location 17:**

**City:** Bronx

**Country:** United States

**Facility:** Investigative Site

**State:** New York

**Zip:** 10456

**Location 18:**

**City:** Houston

**Country:** United States

**Facility:** Investigative Site

**State:** Texas

**Zip:** 77090

**Location 19:**

**City:** Sarnia

**Country:** Canada

**Facility:** Investigative Site

**State:** Ontario

**Zip:** N7T 4X3

**Location 20:**

**City:** Toronto

**Country:** Canada

**Facility:** Investigative Site

**State:** Ontario

**Zip:** M9V 4B4

**Location 21:**

**City:** Milano

**Country:** Italy

**Facility:** Investigative Site

**Zip:** 20132

**Location 22:**

**City:** Daejeon

**Country:** Korea, Republic of

**Facility:** Investigative Site

**Zip:** 35015

**Location 23:**

**City:** Alicante

**Country:** Spain

**Facility:** Investigative Site

**Zip:** 03010

**Location 24:**

**City:** Barcelona

**Country:** Spain

**Facility:** Investigative Site

**Zip:** 08006

**Location 25:**

**City:** Centelles

**Country:** Spain

**Facility:** Investigative Site

**Zip:** 08540

**Location 26:**

**City:** Granada

**Country:** Spain

**Facility:** Investigative Site

**Zip:** 18014

**Location 27:**

**City:** La Roca Del Vallès

**Country:** Spain

**Facility:** Investigative Site

**Zip:** 08430

**Location 28:**

**City:** Madrid

**Country:** Spain

**Facility:** Investigative Site

**Zip:** 28031

**Location 29:**

**City:** Madrid

**Country:** Spain

**Facility:** Investigative Site

**Zip:** 28040

**Location 30:**

**City:** Pozuelo De Alarcón

**Country:** Spain

**Facility:** Investigative Site

**Zip:** 28223

**Location 31:**

**City:** Vigo

**Country:** Spain

**Facility:** Investigative Site

**Zip:** 36312

### References Module

#### References

**Citation:** Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

**PMID:** 34473343

## Document Section

### Large Document Module

#### Large Docs

- Date: 2021-10-29

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 1381436

- Type Abbrev: Prot

- Upload Date: 2022-08-16T17:33

- Date: 2022-03-15

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 787503

- Type Abbrev: SAP

- Upload Date: 2022-08-16T17:33

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000018352

- Term: Coronavirus Infections

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: COVID-19

- ID: M20490

- Name: Coronavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000086382

- Term: COVID-19

### Intervention Browse Module - Ancestors

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M349835

- Name: Sotrovimab

- Relevance: HIGH

- As Found: Viscosity

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000711967

- Term: Sotrovimab

### Misc Info Module

#### Submission Tracking

##### First MCP Info

###### Post Date

- Date: 2022-09-22

- Type: ACTUAL

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Safety Population consisted of all randomized participants who were exposed to study intervention.

#### Event Groups

**Group ID:** EG000

**Title:** Part A-Sotrovimab Gen1: 500 mg IV

**Deaths Num At Risk:** 8

**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.

**ID:** EG000

**Other Num at Risk:** 8

**Serious Number At Risk:** 8

**Title:** Part A-Sotrovimab Gen1: 500 mg IV

**Group ID:** EG001

**Title:** Part A- Sotrovimab Gen2: 500 mg IV

**Deaths Num At Risk:** 22

**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.

**ID:** EG001

**Other Num Affected:** 6

**Other Num at Risk:** 22

**Serious Number At Risk:** 22

**Title:** Part A- Sotrovimab Gen2: 500 mg IV

**Group ID:** EG002

**Title:** Part B- Sotrovimab Gen2: 500 mg IV

**Deaths Num At Risk:** 84

**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.

**ID:** EG002

**Other Num Affected:** 8

**Other Num at Risk:** 84

**Serious Number Affected:** 1

**Serious Number At Risk:** 84

**Title:** Part B- Sotrovimab Gen2: 500 mg IV

**Group ID:** EG003

**Title:** Part B- Sotrovimab Gen2: 500 mg IM

**Deaths Num At Risk:** 82

**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.

**ID:** EG003

**Other Num Affected:** 20

**Other Num at Risk:** 82

**Serious Number Affected:** 2

**Serious Number At Risk:** 82

**Title:** Part B- Sotrovimab Gen2: 500 mg IM

**Group ID:** EG004

**Title:** Part C- Sotrovimab Gen2: 500 mg IV

**Deaths Num At Risk:** 79

**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.

**ID:** EG004

**Other Num Affected:** 16

**Other Num at Risk:** 79

**Serious Number Affected:** 2

**Serious Number At Risk:** 79

**Title:** Part C- Sotrovimab Gen2: 500 mg IV

**Group ID:** EG005

**Title:** Part C- Sotrovimab Gen2: 250 mg IM

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 78

**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.

**ID:** EG005

**Other Num Affected:** 16

**Other Num at Risk:** 78

**Serious Number Affected:** 3

**Serious Number At Risk:** 78

**Title:** Part C- Sotrovimab Gen2: 250 mg IM

**Frequency Threshold:** 1

#### Other Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Iron deficiency anemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Motion sickness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** vertigo

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Episcleritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Abdominal discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Aphthous ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Dyspepsia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Paraesthesia Oral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Uvulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Feeling abnormal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Influenza like illness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Injection site discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** General disorders and administration site conditions

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Injection site nodule

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** General disorders and administration site conditions

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Injection site pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** General disorders and administration site conditions

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Peripheral swelling

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** General disorders and administration site conditions

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Hypertransaminasaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Acute sinusitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.0

**Term:** Blister infected

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.0

**Term:** Cellulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.0

**Term:** Conjunctivitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.0

**Term:** Folliculitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.0

**Term:** Helicobacter gastritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.0

**Term:** Herpes simplex

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.0

**Term:** Herpes zoster

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.0

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.0

**Term:** Otitis media acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.0

**Term:** Pharyngitis streptococcal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.0

**Term:** Sinusitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.0

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.0

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.0

**Term:** Fall

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 24.0

**Term:** Limb injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 24.0

**Term:** Alanine aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 24.0

**Term:** Aspartate aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 24.0

**Term:** Brain natriuretic peptide increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 24.0

**Term:** Hepatic enzyme increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 24.0

**Term:** Lipase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 24.0

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Gout

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Hyperlipasaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Hypokalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Vitamin D deficiency

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Neck pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Pain in jaw

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Migraine

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Restless legs syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Conversion disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Depression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Nephrolithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Acute respiratory failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Oropharyngeal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Rhinorrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Sleep apnoea syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Alopecia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Urticaria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 24.0

**Term:** Superficial vein thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 24.0

#### Serious Events

**Term:** COVID-19 pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 8

**Group ID:** EG001

**Num At Risk:** 22

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 84

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 82

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 79

**Num Events:** 1

**Group ID:** EG005

**Num Affected:** 3

**Num At Risk:** 78

**Num Events:** 3

**Term:** Coronavirus pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 8

**Group ID:** EG001

**Num At Risk:** 22

**Group ID:** EG002

**Num At Risk:** 84

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 82

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 79

**Group ID:** EG005

**Num At Risk:** 78

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 8

**Group ID:** EG001

**Num At Risk:** 22

**Group ID:** EG002

**Num At Risk:** 84

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 82

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 79

**Group ID:** EG005

**Num At Risk:** 78

**Term:** Incisional hernia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 24.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 8

**Group ID:** EG001

**Num At Risk:** 22

**Group ID:** EG002

**Num At Risk:** 84

**Group ID:** EG003

**Num At Risk:** 82

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 79

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 78

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 24.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 8

**Group ID:** EG001

**Num At Risk:** 22

**Group ID:** EG002

**Num At Risk:** 84

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 82

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 79

**Group ID:** EG005

**Num At Risk:** 78

**Term:** Acute respiratory failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 24.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 8

**Group ID:** EG001

**Num At Risk:** 22

**Group ID:** EG002

**Num At Risk:** 84

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 82

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 79

**Group ID:** EG005

**Num At Risk:** 78

**Time Frame:** All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 8

**Group ID:** BG001

**Value:** 22

**Group ID:** BG002

**Value:** 84

**Group ID:** BG003

**Value:** 82

**Group ID:** BG004

**Value:** 79

**Group ID:** BG005

**Value:** 78

**Group ID:** BG006

**Value:** 353

**Units:** Participants

### Group

**ID:** BG000

**Title:** Part A-Sotrovimab Gen1: 500 mg IV

**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.

### Group

**ID:** BG001

**Title:** Part A- Sotrovimab Gen2: 500 mg IV

**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.

### Group

**ID:** BG002

**Title:** Part B- Sotrovimab Gen2: 500 mg IV

**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.

### Group

**ID:** BG003

**Title:** Part B- Sotrovimab Gen2: 500 mg IM

**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.

### Group

**ID:** BG004

**Title:** Part C- Sotrovimab Gen2: 500 mg IV

**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.

### Group

**ID:** BG005

**Title:** Part C- Sotrovimab Gen2: 250 mg IM

**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.

### Group

**ID:** BG006

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 1

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 2

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 20

#### Measurement

**Group ID:** BG002

**Value:** 80

#### Measurement

**Group ID:** BG003

**Value:** 76

#### Measurement

**Group ID:** BG004

**Value:** 77

#### Measurement

**Group ID:** BG005

**Value:** 74

#### Measurement

**Group ID:** BG006

**Value:** 335

**Category Title:** 19-64 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 4

#### Measurement

**Group ID:** BG003

**Value:** 5

#### Measurement

**Group ID:** BG004

**Value:** 2

#### Measurement

**Group ID:** BG005

**Value:** 4

#### Measurement

**Group ID:** BG006

**Value:** 16

**Category Title:** >=65 years

**Class Title:** Participants

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 10

#### Measurement

**Group ID:** BG002

**Value:** 45

#### Measurement

**Group ID:** BG003

**Value:** 42

#### Measurement

**Group ID:** BG004

**Value:** 39

#### Measurement

**Group ID:** BG005

**Value:** 42

#### Measurement

**Group ID:** BG006

**Value:** 183

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 12

#### Measurement

**Group ID:** BG002

**Value:** 39

#### Measurement

**Group ID:** BG003

**Value:** 40

#### Measurement

**Group ID:** BG004

**Value:** 40

#### Measurement

**Group ID:** BG005

**Value:** 36

#### Measurement

**Group ID:** BG006

**Value:** 170

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 4

#### Measurement

**Group ID:** BG003

**Value:** 1

#### Measurement

**Group ID:** BG004

**Value:** 7

#### Measurement

**Group ID:** BG005

**Value:** 9

#### Measurement

**Group ID:** BG006

**Value:** 24

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 21

#### Measurement

**Group ID:** BG002

**Value:** 62

#### Measurement

**Group ID:** BG003

**Value:** 64

#### Measurement

**Group ID:** BG004

**Value:** 66

#### Measurement

**Group ID:** BG005

**Value:** 63

#### Measurement

**Group ID:** BG006

**Value:** 282

**Category Title:** White - White/Caucasian/European Heritage

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 5

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 6

#### Measurement

**Group ID:** BG005

**Value:** 5

#### Measurement

**Group ID:** BG006

**Value:** 16

**Category Title:** White - Arabic/North African Heritage

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 2

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 4

**Category Title:** Asian - East Asian Heritage

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 11

#### Measurement

**Group ID:** BG003

**Value:** 13

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 24

**Category Title:** Asian - South East Asian Heritage

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 1

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 1

**Category Title:** Asian - Central/South Asian Heritage

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 1

#### Measurement

**Group ID:** BG006

**Value:** 1

**Category Title:** American Indian Or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 1

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 1

**Category Title:** Mixed Asian Race

**Class Title:** Participants

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Description:** Safety Population consisted of all randomized participants who were exposed to study intervention.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Customized
**Unit of Measure:** Participants
### Measure 2
**Description:** Safety Population consisted of all randomized participants who were exposed to study intervention.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Description:** Safety Population consisted of all randomized participants who were exposed to study intervention.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Restrictive Agreement:** True
### Point of Contact
**Email:** clinicaltrials@vir.bio
**Organization:** Vir Biotechnology, Inc.
**Phone:** 415-654-5281
**Title:** Study Inquiry
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** 0.98
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 1.09
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Analysis was performed using an Analysis of covariance (ANCOVA) model with covariates of treatment and Baseline logarithm (base 10) viral load.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Ratio of geometric least squares mean
**Parameter Value:** 1.04
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** 0.94
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 1.11
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Analysis was performed using an ANCOVA model with covariates of treatment, and Baseline logarithm (base10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Ratio of geometric least squares mean
**Parameter Value:** 1.02
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
### Outcome Measure 16
### Outcome Measure 17
### Outcome Measure 18
### Outcome Measure 19
### Outcome Measure 20
### Outcome Measure 21
### Outcome Measure 22
### Outcome Measure 23
### Outcome Measure 24
### Outcome Measure 25
### Outcome Measure 26
### Outcome Measure 27
### Outcome Measure 28
### Outcome Measure 29
### Outcome Measure 30
### Outcome Measure 31
### Outcome Measure 32
### Outcome Measure 33
### Outcome Measure 34
### Outcome Measure 35
#### Analysis
**CI Lower Limit:** 1.00
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 1.11
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Ratio of geometric least squares mean
**Parameter Value:** 1.05
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 36
#### Analysis
**CI Lower Limit:** 0.97
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 1.07
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Ratio of geometric least squares mean
**Parameter Value:** 1.02
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 37
#### Analysis
**CI Lower Limit:** 0.93
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 1.09
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Ratio of geometric least squares mean
**Parameter Value:** 1.01
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 38
#### Analysis
**CI Lower Limit:** 0.94
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 1.10
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Ratio of geometric least squares mean
**Parameter Value:** 1.02
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 39
### Outcome Measure 40
### Outcome Measure 41
### Outcome Measure 42
### Outcome Measure 43
### Outcome Measure 44
### Outcome Measure 45
### Outcome Measure 46
### Outcome Measure 47
### Outcome Measure 48
### Outcome Measure 49
### Outcome Measure 50
### Outcome Measure 51
### Outcome Measure 52
### Outcome Measure 53
### Outcome Measure 54
### Outcome Measure 55
### Outcome Measure 56
### Outcome Measure 57
### Outcome Measure 58
### Outcome Measure 59
### Outcome Measure 60
### Outcome Measure 61
### Outcome Measure 62
### Outcome Measure 63
### Outcome Measure 64
### Outcome Measure 65
### Outcome Measure 66
### Outcome Measure 67
### Outcome Measure 68
### Outcome Measure 69
### Outcome Measure 70
### Outcome Measure 71
### Outcome Measure 72
### Outcome Measure 73
### Outcome Measure 74
### Outcome Measure 75
### Outcome Measure 76
### Outcome Measure 77
### Outcome Measure 78
### Outcome Measure 79
### Outcome Measure 80
### Outcome Measure 81
### Outcome Measure 82
### Outcome Measure 83
### Outcome Measure 84
### Outcome Measure 85
### Outcome Measure 86
### Outcome Measure 87
### Outcome Measure 88
### Outcome Measure 89
### Outcome Measure 90
### Outcome Measure 91
### Outcome Measure 92
### Outcome Measure 93
### Outcome Measure 94
### Outcome Measure 95
### Outcome Measure 96
### Outcome Measure 97
### Outcome Measure 98
### Outcome Measure 99
#### Analysis
**CI Lower Limit:** 0.48
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.89
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Drug bioavailability was analyzed using an ANCOVA model with treatment and weight at Baseline as covariates.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Ratio of geometric least squares mean
**Parameter Value:** 0.66
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.43
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 0.79
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Drug bioavailability was analyzed using an ANCOVA model with treatment and weight at Baseline as covariates.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Ratio of geometric least squares mean
**Parameter Value:** 0.58
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 100
#### Analysis
**CI Lower Limit:** 0.67
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 1.95
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Ratio of geometric least squares mean
**Parameter Value:** 1.14
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 101
#### Analysis
**CI Lower Limit:** 0.69
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 1.62
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Ratio of geometric least squares mean
**Parameter Value:** 1.06
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 102
#### Analysis
**CI Lower Limit:** 0.68
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 1.82
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Ratio of geometric least squares mean
**Parameter Value:** 1.11
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 103
#### Analysis
**CI Lower Limit:** 0.77
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 90
**CI Upper Limit:** 2.12
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Ratio of geometric least squares mean
**Parameter Value:** 1.28
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 104
### Outcome Measure 105
### Outcome Measure 106
### Outcome Measure 107
### Outcome Measure 108
### Outcome Measure 109
### Outcome Measure 110
### Outcome Measure 111
### Outcome Measure 112
### Outcome Measure 113
### Outcome Measure 114
### Outcome Measure 115
### Outcome Measure 116
### Outcome Measure 117
### Outcome Measure 118
### Outcome Measure 119
### Outcome Measure 120
### Outcome Measure 121
### Outcome Measure 122
### Outcome Measure 123
### Outcome Measure 124
### Outcome Measure 125
### Outcome Measure 126
### Outcome Measure 127
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 23.53
- **Spread:** 
- **Upper Limit:** 25.31
- **Value:** 24.40
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 24.38
- **Spread:** 
- **Upper Limit:** 26.21
- **Value:** 25.28
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 24.68
- **Spread:** 
- **Upper Limit:** 27.81
- **Value:** 26.20
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 25.26
- **Spread:** 
- **Upper Limit:** 28.27
- **Value:** 26.72
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 7
- **Group ID:** OG001
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 7
- **Group ID:** OG001
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 7
- **Group ID:** OG001
- **Value:** 21
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 7
- **Group ID:** OG001
- **Value:** 21
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 8
- **Group ID:** OG001
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 8
- **Group ID:** OG001
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 8
- **Group ID:** OG001
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 8
- **Group ID:** OG001
- **Value:** 22
**Units:** Participants
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 43
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 39
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 18
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 38
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 37
**Title:** 
#### Outcome Measure 19
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 20
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
**Title:** 
#### Outcome Measure 21
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
#### Outcome Measure 22
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 23
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 84
- **Group ID:** OG001
- **Value:** 82
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 33
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 31
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 84
- **Group ID:** OG001
- **Value:** 82
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 80
- **Group ID:** OG001
- **Value:** 78
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 24
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 80
- **Group ID:** OG001
- **Value:** 78
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 82
- **Group ID:** OG001
- **Value:** 78
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 24
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 82
- **Group ID:** OG001
- **Value:** 78
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 78
- **Group ID:** OG001
- **Value:** 79
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 24
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 78
- **Group ID:** OG001
- **Value:** 79
**Units:** Participants
#### Outcome Measure 24
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 25
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16
**Title:** 
#### Outcome Measure 26
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 27
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 28
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 79
- **Group ID:** OG001
- **Value:** 78
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 29
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 79
- **Group ID:** OG001
- **Value:** 78
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 76
- **Group ID:** OG001
- **Value:** 74
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 25
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 23
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 76
- **Group ID:** OG001
- **Value:** 74
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 72
- **Group ID:** OG001
- **Value:** 76
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 23
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 72
- **Group ID:** OG001
- **Value:** 76
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 73
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 23
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 73
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
#### Outcome Measure 29
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
#### Outcome Measure 30
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.4290
- **Upper Limit:** 
- **Value:** -0.270
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.9201
- **Upper Limit:** 
- **Value:** -1.114
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 4
- **Group ID:** OG001
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.3404
- **Upper Limit:** 
- **Value:** -0.780
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.0199
- **Upper Limit:** 
- **Value:** -2.620
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 3
- **Group ID:** OG001
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.5689
- **Upper Limit:** 
- **Value:** -0.507
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.4982
- **Upper Limit:** 
- **Value:** -2.605
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 3
- **Group ID:** OG001
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.5940
- **Upper Limit:** 
- **Value:** -1.043
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.3963
- **Upper Limit:** 
- **Value:** -2.881
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 4
- **Group ID:** OG001
- **Value:** 10
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.3444
- **Upper Limit:** 
- **Value:** -0.610
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.2132
- **Upper Limit:** 
- **Value:** -3.179
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 4
- **Group ID:** OG001
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.5940
- **Upper Limit:** 
- **Value:** -1.043
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.3210
- **Upper Limit:** 
- **Value:** -3.284
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 4
- **Group ID:** OG001
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.5940
- **Upper Limit:** 
- **Value:** -1.043
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.3123
- **Upper Limit:** 
- **Value:** -3.223
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 4
- **Group ID:** OG001
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.9726
- **Upper Limit:** 
- **Value:** -1.252
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.2277
- **Upper Limit:** 
- **Value:** -1.006
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 16
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.1230
- **Upper Limit:** 
- **Value:** -1.755
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.2100
- **Upper Limit:** 
- **Value:** -2.111
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 4
- **Group ID:** OG001
- **Value:** 16
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.7839
- **Upper Limit:** 
- **Value:** -1.705
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.7842
- **Upper Limit:** 
- **Value:** -2.703
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 4
- **Group ID:** OG001
- **Value:** 16
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.3363
- **Upper Limit:** 
- **Value:** -2.810
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.5656
- **Upper Limit:** 
- **Value:** -2.923
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 16
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.3243
- **Upper Limit:** 
- **Value:** -2.490
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.7103
- **Upper Limit:** 
- **Value:** -3.445
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 16
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.2826
- **Upper Limit:** 
- **Value:** -2.668
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.9434
- **Upper Limit:** 
- **Value:** -3.873
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 16
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.3363
- **Upper Limit:** 
- **Value:** -2.810
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.8030
- **Upper Limit:** 
- **Value:** -3.752
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 16
**Units:** Participants
#### Outcome Measure 31
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.1558
- **Upper Limit:** 
- **Value:** -1.146
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.1518
- **Upper Limit:** 
- **Value:** -0.611
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 63
- **Group ID:** OG001
- **Value:** 68
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.2033
- **Upper Limit:** 
- **Value:** -1.438
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.3132
- **Upper Limit:** 
- **Value:** -1.306
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 63
- **Group ID:** OG001
- **Value:** 66
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.2480
- **Upper Limit:** 
- **Value:** -2.578
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.1655
- **Upper Limit:** 
- **Value:** -2.352
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 62
- **Group ID:** OG001
- **Value:** 64
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.4553
- **Upper Limit:** 
- **Value:** -3.069
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.4193
- **Upper Limit:** 
- **Value:** -3.254
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 64
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.7148
- **Upper Limit:** 
- **Value:** -3.522
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.4907
- **Upper Limit:** 
- **Value:** -3.574
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 62
- **Group ID:** OG001
- **Value:** 63
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.7443
- **Upper Limit:** 
- **Value:** -3.705
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.5525
- **Upper Limit:** 
- **Value:** -3.733
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 62
- **Group ID:** OG001
- **Value:** 66
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.7994
- **Upper Limit:** 
- **Value:** -3.831
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.7476
- **Upper Limit:** 
- **Value:** -3.778
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 66
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.8253
- **Upper Limit:** 
- **Value:** -3.933
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.7455
- **Upper Limit:** 
- **Value:** -3.857
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 62
- **Group ID:** OG001
- **Value:** 64
**Units:** Participants
#### Outcome Measure 32
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.3835
- **Upper Limit:** 
- **Value:** -0.429
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.3273
- **Upper Limit:** 
- **Value:** -0.519
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 59
- **Group ID:** OG001
- **Value:** 64
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.5202
- **Upper Limit:** 
- **Value:** -0.905
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.6172
- **Upper Limit:** 
- **Value:** -1.123
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 50
- **Group ID:** OG001
- **Value:** 57
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.9648
- **Upper Limit:** 
- **Value:** -2.076
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.0218
- **Upper Limit:** 
- **Value:** -1.967
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 57
- **Group ID:** OG001
- **Value:** 62
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.8234
- **Upper Limit:** 
- **Value:** -3.122
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.8324
- **Upper Limit:** 
- **Value:** -3.180
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 55
- **Group ID:** OG001
- **Value:** 62
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.6870
- **Upper Limit:** 
- **Value:** -3.617
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.8168
- **Upper Limit:** 
- **Value:** -3.738
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 52
- **Group ID:** OG001
- **Value:** 61
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.8248
- **Upper Limit:** 
- **Value:** -3.719
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.8148
- **Upper Limit:** 
- **Value:** -3.836
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 50
- **Group ID:** OG001
- **Value:** 61
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.7647
- **Upper Limit:** 
- **Value:** -3.693
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.7492
- **Upper Limit:** 
- **Value:** -3.956
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 55
- **Group ID:** OG001
- **Value:** 65
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.8167
- **Upper Limit:** 
- **Value:** -3.761
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.7189
- **Upper Limit:** 
- **Value:** -3.963
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 56
- **Group ID:** OG001
- **Value:** 63
**Units:** Participants
#### Outcome Measure 33
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 63
- **Group ID:** OG001
- **Value:** 68
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 63
- **Group ID:** OG001
- **Value:** 66
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 23
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 27
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 62
- **Group ID:** OG001
- **Value:** 64
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 34
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 38
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 64
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 58
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 51
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 62
- **Group ID:** OG001
- **Value:** 63
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 61
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 73
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 62
- **Group ID:** OG001
- **Value:** 66
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 73
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 74
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 64
- **Group ID:** OG001
- **Value:** 66
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 81
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 84
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 62
- **Group ID:** OG001
- **Value:** 64
**Units:** Participants
#### Outcome Measure 34
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 59
- **Group ID:** OG001
- **Value:** 64
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 50
- **Group ID:** OG001
- **Value:** 57
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 57
- **Group ID:** OG001
- **Value:** 62
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 42
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 39
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 55
- **Group ID:** OG001
- **Value:** 62
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 63
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 72
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 52
- **Group ID:** OG001
- **Value:** 61
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 82
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 80
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 50
- **Group ID:** OG001
- **Value:** 61
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 80
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 88
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 55
- **Group ID:** OG001
- **Value:** 65
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 88
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 86
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 56
- **Group ID:** OG001
- **Value:** 63
**Units:** Participants
#### Outcome Measure 35
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 15.53
- **Spread:** 
- **Upper Limit:** 16.77
- **Value:** 16.14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 16.34
- **Spread:** 
- **Upper Limit:** 17.62
- **Value:** 16.97
**Title:** 
#### Outcome Measure 36
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 30.60
- **Spread:** 
- **Upper Limit:** 32.82
- **Value:** 31.69
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 31.28
- **Spread:** 
- **Upper Limit:** 33.53
- **Value:** 32.39
**Title:** 
#### Outcome Measure 37
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 16.49
- **Spread:** 
- **Upper Limit:** 18.41
- **Value:** 17.42
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 16.66
- **Spread:** 
- **Upper Limit:** 18.51
- **Value:** 17.56
**Title:** 
#### Outcome Measure 38
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 31.17
- **Spread:** 
- **Upper Limit:** 34.97
- **Value:** 33.02
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 31.89
- **Spread:** 
- **Upper Limit:** 35.47
- **Value:** 33.63
**Title:** 
#### Outcome Measure 39
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 83
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 89
**Title:** 
#### Outcome Measure 40
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 85
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 87
**Title:** 
#### Outcome Measure 41
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 48.28
- **Upper Limit:** 
- **Value:** 147.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 77.61
- **Upper Limit:** 
- **Value:** 204.7
**Title:** 
#### Outcome Measure 42
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 40.80
- **Upper Limit:** 
- **Value:** 156.5
**Title:** 
#### Outcome Measure 43
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 15.66
- **Upper Limit:** 
- **Value:** 28.8
**Title:** 
#### Outcome Measure 44
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 32.97
- **Upper Limit:** 
- **Value:** 137.4
**Title:** 
#### Outcome Measure 45
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.61
- **Upper Limit:** 
- **Value:** 11.1
**Title:** 
#### Outcome Measure 46
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.16
- **Upper Limit:** 
- **Value:** 6.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.17
- **Upper Limit:** 
- **Value:** 8.1
**Title:** 
#### Outcome Measure 47
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.48
- **Upper Limit:** 
- **Value:** 7.0
**Title:** 
#### Outcome Measure 48
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.65
- **Upper Limit:** 
- **Value:** 7.9
**Title:** 
#### Outcome Measure 49
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 12.59
- **Upper Limit:** 
- **Value:** 10.5
**Title:** 
#### Outcome Measure 50
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.73
- **Upper Limit:** 
- **Value:** 2.6
**Title:** 
#### Outcome Measure 51
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.04
- **Spread:** 
- **Upper Limit:** 0.38
- **Value:** 0.042
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.04
- **Spread:** 
- **Upper Limit:** 0.38
- **Value:** 0.042
**Title:** 
#### Outcome Measure 52
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.01
- **Spread:** 
- **Upper Limit:** 0.03
- **Value:** 0.026
**Title:** 
#### Outcome Measure 53
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.68
- **Spread:** 
- **Upper Limit:** 56.66
- **Value:** 6.878
**Title:** 
#### Outcome Measure 54
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.01
- **Spread:** 
- **Upper Limit:** 0.02
- **Value:** 0.014
**Title:** 
#### Outcome Measure 55
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 13.88
- **Spread:** 
- **Upper Limit:** 56.04
- **Value:** 27.866
**Title:** 
#### Outcome Measure 56
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 160.89
- **Spread:** 
- **Upper Limit:** 174.95
- **Value:** 161.333
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 160.70
- **Spread:** 
- **Upper Limit:** 180.15
- **Value:** 162.248
**Title:** 
#### Outcome Measure 57
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 160.76
- **Spread:** 
- **Upper Limit:** 175.68
- **Value:** 167.715
**Title:** 
#### Outcome Measure 58
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 55.68
- **Spread:** 
- **Upper Limit:** 175.66
- **Value:** 167.670
**Title:** 
#### Outcome Measure 59
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 27.79
- **Spread:** 
- **Upper Limit:** 185.75
- **Value:** 162.458
**Title:** 
#### Outcome Measure 60
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 160.97
- **Spread:** 
- **Upper Limit:** 180.83
- **Value:** 168.912
**Title:** 
#### Outcome Measure 61
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 392.56
- **Upper Limit:** 
- **Value:** 1355.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 308.31
- **Upper Limit:** 
- **Value:** 1738.8
**Title:** 
#### Outcome Measure 62
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 296.96
- **Upper Limit:** 
- **Value:** 1442.9
**Title:** 
#### Outcome Measure 63
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 376.78
- **Upper Limit:** 
- **Value:** 686.9
**Title:** 
#### Outcome Measure 64
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 528.26
- **Upper Limit:** 
- **Value:** 1405.4
**Title:** 
#### Outcome Measure 65
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 242.84
- **Upper Limit:** 
- **Value:** 327.1
**Title:** 
#### Outcome Measure 66
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1289.19
- **Upper Limit:** 
- **Value:** 3982.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 966.33
- **Upper Limit:** 
- **Value:** 5238.4
**Title:** 
#### Outcome Measure 67
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1123.41
- **Upper Limit:** 
- **Value:** 4449.3
**Title:** 
#### Outcome Measure 68
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1617.36
- **Upper Limit:** 
- **Value:** 3194.4
**Title:** 
#### Outcome Measure 69
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1369.36
- **Upper Limit:** 
- **Value:** 4255.3
**Title:** 
#### Outcome Measure 70
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 985.65
- **Upper Limit:** 
- **Value:** 1441.0
**Title:** 
#### Outcome Measure 71
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1086.56
- **Upper Limit:** 
- **Value:** 3456.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 826.89
- **Upper Limit:** 
- **Value:** 4528.5
**Title:** 
#### Outcome Measure 72
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 899.51
- **Upper Limit:** 
- **Value:** 3848.5
**Title:** 
#### Outcome Measure 73
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1249.20
- **Upper Limit:** 
- **Value:** 2446.5
**Title:** 
#### Outcome Measure 74
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1257.27
- **Upper Limit:** 
- **Value:** 3492.6
**Title:** 
#### Outcome Measure 75
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 763.78
- **Upper Limit:** 
- **Value:** 1185.8
**Title:** 
#### Outcome Measure 76
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.81
- **Upper Limit:** 
- **Value:** 14.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.42
- **Upper Limit:** 
- **Value:** 12.6
**Title:** 
#### Outcome Measure 77
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.92
- **Upper Limit:** 
- **Value:** 13.1
**Title:** 
#### Outcome Measure 78
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.35
- **Upper Limit:** 
- **Value:** 15.0
**Title:** 
#### Outcome Measure 79
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.29
- **Upper Limit:** 
- **Value:** 13.6
**Title:** 
#### Outcome Measure 80
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.11
- **Upper Limit:** 
- **Value:** 15.0
**Title:** 
#### Outcome Measure 81
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 53.98
- **Spread:** 
- **Upper Limit:** 68.09
- **Value:** 63.196
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 42.34
- **Spread:** 
- **Upper Limit:** 72.09
- **Value:** 55.547
**Title:** 
#### Outcome Measure 82
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 47.33
- **Spread:** 
- **Upper Limit:** 66.86
- **Value:** 55.735
**Title:** 
#### Outcome Measure 83
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 51.95
- **Spread:** 
- **Upper Limit:** 65.83
- **Value:** 59.347
**Title:** 
#### Outcome Measure 84
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 42.96
- **Spread:** 
- **Upper Limit:** 70.84
- **Value:** 60.938
**Title:** 
#### Outcome Measure 85
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 46.84
- **Spread:** 
- **Upper Limit:** 68.43
- **Value:** 61.867
**Title:** 
#### Outcome Measure 86
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.625
- **Upper Limit:** 
- **Value:** 12.40
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.374
- **Upper Limit:** 
- **Value:** 7.88
**Title:** 
#### Outcome Measure 87
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.865
- **Upper Limit:** 
- **Value:** 9.97
**Title:** 
#### Outcome Measure 88
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 12.752
- **Upper Limit:** 
- **Value:** 18.14
**Title:** 
#### Outcome Measure 89
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.574
- **Upper Limit:** 
- **Value:** 10.93
**Title:** 
#### Outcome Measure 90
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 10.205
- **Upper Limit:** 
- **Value:** 20.24
**Title:** 
#### Outcome Measure 91
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.110
- **Upper Limit:** 
- **Value:** 11.42
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.232
- **Upper Limit:** 
- **Value:** 7.47
**Title:** 
#### Outcome Measure 92
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.514
- **Upper Limit:** 
- **Value:** 9.41
**Title:** 
#### Outcome Measure 93
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.973
- **Upper Limit:** 
- **Value:** 10.61
**Title:** 
#### Outcome Measure 94
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 42.88
- **Upper Limit:** 
- **Value:** 136.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 18.62
- **Upper Limit:** 
- **Value:** 98.7
**Title:** 
#### Outcome Measure 95
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 35.96
- **Upper Limit:** 
- **Value:** 120.3
**Title:** 
#### Outcome Measure 96
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 162.28
- **Upper Limit:** 
- **Value:** 216.2
**Title:** 
#### Outcome Measure 97
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 47.83
- **Upper Limit:** 
- **Value:** 130.5
**Title:** 
#### Outcome Measure 98
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 125.67
- **Upper Limit:** 
- **Value:** 237.8
**Title:** 
#### Outcome Measure 99
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.25
- **Spread:** 
- **Upper Limit:** 7.16
- **Value:** 5.52
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3.75
- **Spread:** 
- **Upper Limit:** 6.30
- **Value:** 4.86
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 7.12
- **Spread:** 
- **Upper Limit:** 9.90
- **Value:** 8.40
**Title:** 
#### Outcome Measure 100
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.81
- **Spread:** 
- **Upper Limit:** 8.11
- **Value:** 5.56
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3.33
- **Spread:** 
- **Upper Limit:** 7.09
- **Value:** 4.86
**Title:** 
#### Outcome Measure 101
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.21
- **Spread:** 
- **Upper Limit:** 5.77
- **Value:** 4.31
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.98
- **Spread:** 
- **Upper Limit:** 5.51
- **Value:** 4.05
**Title:** 
#### Outcome Measure 102
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.83
- **Spread:** 
- **Upper Limit:** 1.65
- **Value:** 1.17
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.74
- **Spread:** 
- **Upper Limit:** 1.51
- **Value:** 1.06
**Title:** 
#### Outcome Measure 103
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.04
- **Spread:** 
- **Upper Limit:** 0.07
- **Value:** 0.05
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.03
- **Spread:** 
- **Upper Limit:** 0.06
- **Value:** 0.04
**Title:** 
#### Outcome Measure 104
#### Outcome Measure 105
#### Outcome Measure 106
#### Outcome Measure 107
#### Outcome Measure 108
#### Outcome Measure 109
#### Outcome Measure 110
#### Outcome Measure 111
#### Outcome Measure 112
#### Outcome Measure 113
#### Outcome Measure 114
#### Outcome Measure 115
#### Outcome Measure 116
#### Outcome Measure 117
#### Outcome Measure 118
#### Outcome Measure 119
#### Outcome Measure 120
#### Outcome Measure 121
#### Outcome Measure 122
#### Outcome Measure 123
#### Outcome Measure 124
#### Outcome Measure 125
#### Outcome Measure 126
#### Outcome Measure 127
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population consisted of all randomized participants who were exposed to study intervention.
**Reporting Status:** POSTED
**Time Frame:** Up to Day 29
**Title:** Part A: Number of Participants With All Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Day 29
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 2
**Description:** An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were infusion-related reactions (IRR) including hypersensitivity, events related to antibody-dependent enhancement, and events related to immunogenicity.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** Up to Day 29
**Title:** Part A: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 3
**Description:** Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** Up to Day 29
**Title:** Part A: Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) Findings Through Day 29
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 4
**Description:** AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** Up to Day 29
**Title:** Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 5
**Description:** AUC of SARS-CoV-2 viral load was measured by Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from Day 1 to Day 8 in nasopharyngeal (NP) swab samples. Analysis was performed using an Analysis of covariance (ANCOVA) model with covariates of treatment and Baseline logarithm (base 10) viral load.
**Dispersion Type:** 90% Confidence Interval
**Parameter Type:** GEOMETRIC_LEAST_SQUARES_MEAN
**Population Description:** Viral Pharmacodynamic Population consisted of all participants in the Safety Population who had a Baseline (Day 1) quantifiable viral load as assessed using qRT-PCR from NP swabs. Only those participants with data available at the specified time points without missing covariate information were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1 to Day 8
**Title:** Part B: Mean Area Under the Curve (AUC) of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Viral Load From Day 1 to Day 8 (AUCD1-8)
**Type:** PRIMARY
**Unit of Measure:** Day*log10 copies per (/) milliliter (mL)
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 6
**Description:** AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 8 in NP swab samples. Analysis was performed using an ANCOVA model with covariates of treatment, and Baseline logarithm (base10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).
**Dispersion Type:** 90% Confidence Interval
**Parameter Type:** GEOMETRIC_LEAST_SQUARES_MEAN
**Population Description:** Viral Pharmacodynamic Population. Only those participants with data available at the specified time points without missing covariate information were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1 to Day 8
**Title:** Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 8 (AUCD1-8)
**Type:** PRIMARY
**Unit of Measure:** Day*log10 copies/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 7
**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Adverse events which were not Serious were considered as Non-Serious adverse events.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 12
**Title:** Part A: Number of Participants With Non-Serious AEs Through Week 12
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 8
**Description:** A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 24
**Title:** Part A: Number of Participants With SAEs Through Week 24
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 9
**Description:** An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs are infusion-related reactions (IRR) including hypersensitivity, events related to antibody-dependent enhancement, and events related to immunogenicity.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 24
**Title:** Part A: Number of Participants With AESI Through Week 24
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 10
**Description:** Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population. Only those participants with data available at the specified time points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Days 1, 5, 11 and 85 (Week 12)
**Title:** Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 11
**Description:** AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 24
**Title:** Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Week 24
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 12
**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before. Adverse events include both Serious and Other Adverse Events.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population
**Reporting Status:** POSTED
**Time Frame:** Up to Day 29
**Title:** Part B: Number of Participants With All AEs and SAEs Through Day 29
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 13
**Description:** An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were infusion/injection-related reactions (IRR) including hypersensitivity; injection site reactions (ISRs); events related to antibody-dependent enhancement; events related to immunogenicity.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** Up to Day 29
**Title:** Part B: Number of Participants With AESI Through Day 29
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 14
**Description:** Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** Up to Day 29
**Title:** Part B: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 15
**Description:** AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** Up to Day 29
**Title:** Part B: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 16
**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before. Adverse events include both Serious and Other Adverse Events.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population
**Reporting Status:** POSTED
**Time Frame:** Up to Day 29
**Title:** Part C: Number of Participants With All AEs and SAEs Through Day 29
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 17
**Description:** An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were infusion/injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); events related to antibody-dependent enhancement, and events related to immunogenicity.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** Up to Day 29
**Title:** Part C: Number of Participants With AESI Through Day 29
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 18
**Description:** Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** Up to Day 29
**Title:** Part C: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 19
**Description:** AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** Up to Day 29
**Title:** Part C: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 20
**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 12
**Title:** Part B: Number of Participants With Non-Serious AEs Through Week 12
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 21
**Description:** A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 36
**Title:** Part B: Number of Participants With SAEs Through Week 36
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 22
**Description:** An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs are infusion/injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); events related to antibody-dependent enhancement, and events related to immunogenicity.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** up to Week 36
**Title:** Part B: Number of Participants With AESI Through Week 36
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 23
**Description:** Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population. Only those participants with data available at the specified time points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Days 1, 5, 11 and 85 (Week 12)
**Title:** Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 24
**Description:** AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 36
**Title:** Part B: Number of Participants With Disease Progression Events Through Week 36
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 25
**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 12
**Title:** Part C: Number of Participants With Non-Serious AEs Through Week 12
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 26
**Description:** A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 36
**Title:** Part C: Number of Participants With SAEs Through Week 36
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 27
**Description:** An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs are infusion/injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); events related to antibody-dependent enhancement, and events related to immunogenicity.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 36
**Title:** Part C: Number of Participants With AESI Through Week 36
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 28
**Description:** Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Days 1, 5, 11 and 85 (Week 12)
**Title:** Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 29
**Description:** AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 36
**Title:** Part C: Number of Participants With Disease Progression Events Through Week 36
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 30
**Description:** SARS-CoV-2 viral load was based on saliva and nasal mid-turbinate swab samples and was measured by qRT-PCR. Baseline log10 viral load was defined as the non-missing assessment taken at Day 1 excluding the NEG and \<2.08 results. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Virology Population consisted of all participants in the Safety Population with a central lab confirmed quantifiable nasal mid-turbinate and/or saliva swab at Baseline. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
**Reporting Status:** POSTED
**Time Frame:** Baseline, Days 2, 5, 8, 11, 15, 22 and 29
**Title:** Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load
**Type:** SECONDARY
**Unit of Measure:** Log10 copies/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 31
**Description:** Viral load was based on nasopharyngeal swab samples and was measured by qRT-PCR. Baseline log10 viral load was defined as the non-missing assessment taken at Day 1 excluding the "NEG" and "\<2.08" results. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Viral Pharmacodynamic Population consisted of all participants in the Safety Population who had a Baseline (Day 1) quantifiable viral load as assessed using qRT-PCR from NP swabs. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
**Reporting Status:** POSTED
**Time Frame:** Baseline, Days 2, 3, 5, 8, 11, 15, 22 and 29
**Title:** Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples
**Type:** SECONDARY
**Unit of Measure:** Log10 copies/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 32
**Description:** Viral load was based on nasopharyngeal swab samples and was measured by qRT-PCR. Baseline log10 viral load was defined as the non-missing assessment taken at Day 1 excluding the "NEG" and "\<2.08" results. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Viral Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
**Reporting Status:** POSTED
**Time Frame:** Baseline, Days 2, 3, 5, 8, 11, 15, 22 and 29
**Title:** Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples
**Type:** SECONDARY
**Unit of Measure:** Log10 copies per milliliter
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 33
**Description:** Viral load was measured by qRT-PCR from nasopharyngeal swab samples. Viral load (log10 copies/mL) values recorded as negative were considered as undetectable viral load. Percentage of participants with undetectable viral load have been presented. Percentage values are rounded off.
**Parameter Type:** NUMBER
**Population Description:** Viral Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
**Reporting Status:** POSTED
**Time Frame:** Days 2, 3, 5, 8, 11, 15, 22 and 29
**Title:** Part B: Percentage of Participants With Undetectable Viral Load
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 34
**Description:** Viral load was measured by qRT-PCR from nasopharyngeal swab samples. Viral load (log10 copies/mL) values recorded as negative were considered as undetectable viral load. Percentage of participants with undetectable viral load have been presented. Percentage values are rounded off.
**Parameter Type:** NUMBER
**Population Description:** Viral Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
**Reporting Status:** POSTED
**Time Frame:** Days 2, 3, 5, 8, 11, 15, 22 and 29
**Title:** Part C: Percentage of Participants With Undetectable Viral Load
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 35
**Description:** AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 5. Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.
**Dispersion Type:** 90% Confidence Interval
**Parameter Type:** GEOMETRIC_LEAST_SQUARES_MEAN
**Population Description:** Viral Pharmacodynamic Population. Only those participants with data available at the specified time points without missing covariate information were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1 to Day 5
**Title:** Part B: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5)
**Type:** SECONDARY
**Unit of Measure:** Day*log10 copies/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 36
**Description:** AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 11. Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.
**Dispersion Type:** 90% Confidence Interval
**Parameter Type:** GEOMETRIC_LEAST_SQUARES_MEAN
**Population Description:** Viral Pharmacodynamic Population. Only those participants with data available at the specified time points without missing covariate information were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1 to Day 11
**Title:** Part B: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11)
**Type:** SECONDARY
**Unit of Measure:** Day*log10 copies/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 37
**Description:** AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 5. Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).
**Dispersion Type:** 90% Confidence Interval
**Parameter Type:** GEOMETRIC_LEAST_SQUARES_MEAN
**Population Description:** Viral Pharmacodynamic Population. Only those participants with data available at the specified time points without missing covariate information were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1 to Day 5
**Title:** Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5)
**Type:** SECONDARY
**Unit of Measure:** Day*log10 copies/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 38
**Description:** AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 11. Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).
**Dispersion Type:** 90% Confidence Interval
**Parameter Type:** GEOMETRIC_LEAST_SQUARES_MEAN
**Population Description:** Viral Pharmacodynamic Population. Only those participants with data available at the specified time points without missing covariate information were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1 to Day 11
**Title:** Part C: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11)
**Type:** SECONDARY
**Unit of Measure:** Day*log10 copies/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 39
**Description:** Percentage of participants with a persistently high viral load were categorized as \>=4.1 log10 copies/mL and \<4.1 log10 copies/mL. Percentage of participants with a persistently high viral load at Day 8 was assessed via qRT-PCR in nasopharyngeal swab samples. Percentage of participants with a persistently high viral load at Day 8 has been presented. Percentage values are rounded off.
**Parameter Type:** NUMBER
**Population Description:** Viral Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 8
**Title:** Part B: Percentage of Participants With a Persistently High Viral Load at Day 8
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 40
**Description:** Percentage of participants with a persistently high viral load were categorized as \>=4.1 log10 copies/mL and \<4.1 log10 copies/mL. Percentage of participants with a persistently high viral load at Day 8 was assessed via qRT-PCR in nasopharyngeal swab samples. Percentage of participants with a persistently high viral load at Day 8 has been presented. Percentage values are rounded off.
**Parameter Type:** NUMBER
**Population Description:** Viral Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 8
**Title:** Part C: Percentage of Participants With a Persistently High Viral Load at Day 8
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 41
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population consisted of all participants in the Safety Population who had at least 1 non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values). Only those participants with data available at the specified time points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
**Title:** Part A: Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Microgram per mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 42
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: Cmax of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Microgram per mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 43
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: Cmax of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Microgram per mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 44
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: Cmax of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Microgram per mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 45
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: Cmax of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Microgram per mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 46
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
**Title:** Part A: Concentration at Last Quantifiable Time-point (Clast) of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Microgram per mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 47
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: Clast of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Microgram per mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 48
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: Clast of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Microgram per mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 49
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: Clast of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Microgram per mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 50
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: Clast of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Microgram per mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 51
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
**Title:** Part A: Time to Reach Cmax (Tmax) of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Day
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 52
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: Tmax of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Day
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 53
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: Tmax of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Day
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 54
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: Tmax of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Day
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 55
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: Tmax of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Day
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 56
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** Pharmacokinetic Population. The time frame is beyond Day 169 as there was one PK sample collected outside of the protocol defined window of +/- 7 days that was included in the analysis (PK sample collected up to Day 169 +/- 12 days).
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
**Title:** Part A: Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Day
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 57
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** Pharmacokinetic Population. The upper value of the full range is outside of the time frame due to the protocol defined time point of Day 169+/-7 days.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: Tlast of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Day
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 58
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** Pharmacokinetic Population. The upper value of the full range is outside of the time frame due to the protocol defined time point of Day 169+/-7 days.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: Tlast of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Day
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 59
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** Pharmacokinetic Population. The time frame is beyond Day 169 as there were a few PK samples collected outside of the protocol defined window of +/- 7 days that were included in the analysis (PK samples collected up to Day 169 +/- 18 days).
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: Tlast of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Day
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 60
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** Pharmacokinetic Population. The time frame is beyond Day 169 as there were a few PK samples collected outside of the protocol defined window of +/- 7 days that were included in the analysis (PK samples collected up to Day 169 +/- 18 days).
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: Tlast of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Day
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 61
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29
**Title:** Part A: AUC From Day 1 to 29 (AUCD1-29) of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Day*microgram/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 62
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
**Title:** Part B: AUCD1-29 of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Day*microgram/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 63
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
**Title:** Part B: AUCD1-29 of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Day*microgram/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 64
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
**Title:** Part C: AUCD1-29 of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Day*microgram/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 65
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
**Title:** Part C: AUCD1-29 of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Day*microgram/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 66
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
**Title:** Part A: Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUC[0-inf]) of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Day*microgram/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 67
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: AUC(0-inf) of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Day*microgram/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 68
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: AUC(0-inf) of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Day*microgram/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 69
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: AUC(0-inf) of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Day*microgram/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 70
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: AUC(0-inf) of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Day*microgram/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 71
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
**Title:** Part A: Area Under the Curve From the Time of Dosing to the Time of the Last Measurable (Positive) Concentration (AUClast) of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Day*microgram/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 72
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: AUClast of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Day*microgram/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 73
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: AUClast of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Day*microgram/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 74
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: AUClast of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Day*microgram/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 75
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: AUClast of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Day*microgram/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 76
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
**Title:** Part A: Percentage of AUC(Infinity) Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Percentage of AUCexp
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 77
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: %AUCexp of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Percentage of AUCexp
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 78
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: %AUCexp of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Percentage of AUCexp
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 79
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: %AUCexp of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Percentage of AUCexp
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 80
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: %AUCexp of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Percentage of AUCexp
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 81
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
**Title:** Part A: Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Day
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 82
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: t1/2 of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Day
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 83
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: t1/2 of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Day
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 84
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: t1/2 of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Day
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 85
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: t1/2 of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Day
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 86
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
**Title:** Part A: Apparent Volume of Distribution During the Elimination Phase Following Intravascular Administrtion (Vz) of VIR-7831
**Type:** SECONDARY
**Unit of Measure:** Liter
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 87
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: Vz of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Liter
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 88
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: Apparent Volume of Distribution During the Elimination Phase Following Extravascular Administration (Vz/F) of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Liter
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 89
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: Vz of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Liter
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 90
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: Vz/F of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Liter
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 91
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
**Title:** Part A: Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Liter
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 92
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: Vss of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Liter
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 93
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: Vss of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Liter
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 94
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
**Title:** Part A: Clearance (CL) of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Milliliter per day
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 95
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: CL of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Milliliter per day
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 96
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
**Title:** Part B: Apparent Clearance (CL/F) of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Milliliter per day
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 97
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: CL of VIR-7831 After IV Administration
**Type:** SECONDARY
**Unit of Measure:** Milliliter per day
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 98
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Part C: CL/F of VIR-7831 After IM Administration
**Type:** SECONDARY
**Unit of Measure:** Milliliter per day
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 99
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Dose-normalized least square geometric mean ratio of AUCinf was derived based on collected assessments up to 169 (+/-7 days) for Part B- Sotrovimab Gen2: 500 mg IV arm, and up to 169 (+/-18 days) for Part C- Sotrovimab Gen2: 500 mg IV arm.
**Dispersion Type:** 90% Confidence Interval
**Parameter Type:** GEOMETRIC_LEAST_SQUARES_MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Data from Parts B and C is presented in a single outcome to determine the absolute bioavailability (F) based on the loge transformed dose normalized AUCinf for the IV (500 mg), IM (500 mg), and IM (250 mg). Data for 500 mg IV arms with similar dosing strategies across Parts B and C is combined as pre-specified in reporting and analysis plan.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Dose-normalized Least Square Geometric Mean Ratio of AUCinf for VIR-7831 Gen2 Between the Three Dose Levels (250 mg IM in Part C, 500 mg IM in Part B and 500 mg IV in Parts B and C)
**Type:** SECONDARY
**Unit of Measure:** Day*microgram/mL
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
**ID:** OG002
**Title:** Sotrovimab Gen2: 500 mg IV (Parts B and C)
#### Outcome Measure 100
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** 90% Confidence Interval
**Parameter Type:** GEOMETRIC_LEAST_SQUARES_MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Dose-normalized Least Square Geometric Mean Ratio of AUCinf for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B)
**Type:** SECONDARY
**Unit of Measure:** Day*microgram per milliliter
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 101
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** 90% Confidence Interval
**Parameter Type:** GEOMETRIC_LEAST_SQUARES_MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Dose-normalized Least Square Geometric Mean Ratio of AUClast for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B)
**Type:** SECONDARY
**Unit of Measure:** Day*microgram per milliliter
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 102
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** 90% Confidence Interval
**Parameter Type:** GEOMETRIC_LEAST_SQUARES_MEAN
**Population Description:** Pharmacokinetic Population.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
**Title:** Dose-normalized Least Square Geometric Mean Ratio of AUCD1-D29 for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B)
**Type:** SECONDARY
**Unit of Measure:** Day*microgram per milliliter
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 103
**Description:** Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).
**Dispersion Type:** 90% Confidence Interval
**Parameter Type:** GEOMETRIC_LEAST_SQUARES_MEAN
**Population Description:** Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
**Reporting Status:** POSTED
**Time Frame:** Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
**Title:** Dose-normalized Least Square Geometric Mean Ratio of Cmax for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B)
**Type:** SECONDARY
**Unit of Measure:** Microgram per milliliter
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 104
**Description:** Number of participants with presence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Up to Day 28
**Title:** Part A: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 105
**Description:** Number of participants with presence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Up to Day 28
**Title:** Part B: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 106
**Description:** Number of participants with presence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Up to Day 28
**Title:** Part C: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 107
**Description:** Number of participants with emergence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Up to Day 28
**Title:** Part A: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 108
**Description:** Number of participants with emergence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Up to Day 28
**Title:** Part B: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 109
**Description:** Number of participants with emergence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Up to Day 28
**Title:** Part C: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 110
**Description:** Number of participants with the presence of anti-VIR-7831 antibody was planned to be evaluated. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 24
**Title:** Part A: Number of Participants With the Presence of Anti-VIR-7831 Antibody
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 111
**Description:** Number of participants with the presence of anti-VIR-7831 antibody was planned to be evaluated. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 24
**Title:** Part B: Number of Participants With the Presence of Anti-VIR-7831 Antibody
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 112
**Description:** Number of participants with the presence of anti-VIR-7831 antibody was planned to be evaluated. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 24
**Title:** Part C: Number of Participants With the Presence of Anti-VIR-7831 Antibody
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 113
**Description:** Serum samples were planned to be collected for the determination of anti-drug antibody using a validated electrochemiluminescent (ECL) immunoassay. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 24
**Title:** Part A: Titers of Anti-drug Antibody to VIR-7831
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 114
**Description:** Serum samples were planned to be collected for the determination of anti-drug antibody using a validated ECL immunoassay. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 24
**Title:** Part B: Titers of Anti-drug Antibody to VIR-7831
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 115
**Description:** Serum samples were planned to be collected for the determination of anti-drug antibody using a validated ECL immunoassay. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 24
**Title:** Part C: Titers of Anti-drug Antibody to VIR-7831
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 116
**Description:** Number of participants with the presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 1)
**Title:** Part A: Number of Participants With the Presence of Anti-nucleocapsid (Anti-N), Anti-spike (Anti-S) and Anti-Receptor Binding Domain (Anti-RBD) SARS-CoV-2 Antibodies at Baseline
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 117
**Description:** Number of participants with the presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 1)
**Title:** Part B: Number of Participants With the Presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 118
**Description:** Number of participants with the presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 1)
**Title:** Part C: Number of Participants With the Presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 119
**Description:** Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 1)
**Title:** Part A: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 120
**Description:** Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 1)
**Title:** Part B: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 121
**Description:** Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 1)
**Title:** Part C: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 122
**Description:** Number of participants with the presence of Anti-N SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Day 29
**Title:** Part A: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at Day 29
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 123
**Description:** Number of participants with the presence of Anti-N SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Day 29
**Title:** Part B: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at Day 29
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 124
**Description:** Number of participants with the presence of Anti-N SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Day 29
**Title:** Part C: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at Day 29
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Outcome Measure 125
**Description:** Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Day 29
**Title:** Part A: Titers of Anti-N SARS-CoV-2 Antibodies at Day 29
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** OG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** OG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Outcome Measure 126
**Description:** Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Day 29
**Title:** Part B: Titers of Anti-N SARS-CoV-2 Antibodies at Day 29
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** OG000
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** OG001
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Outcome Measure 127
**Description:** Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.
**Population Description:** Safety Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
**Reporting Status:** POSTED
**Time Frame:** Day 29
**Title:** Part C: Titers of Anti-N SARS-CoV-2 Antibodies at Day 29
**Type:** OTHER_PRE_SPECIFIED
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** OG000
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
##### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** OG001
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
### Participant Flow Module
#### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.
**ID:** FG000
**Title:** Part A-Sotrovimab Gen1: 500 mg IV
#### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.
**ID:** FG001
**Title:** Part A- Sotrovimab Gen2: 500 mg IV
#### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.
**ID:** FG002
**Title:** Part B- Sotrovimab Gen2: 500 mg IV
#### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.
**ID:** FG003
**Title:** Part B- Sotrovimab Gen2: 500 mg IM
#### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.
**ID:** FG004
**Title:** Part C- Sotrovimab Gen2: 500 mg IV
#### Group
**Description:** Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
**ID:** FG005
**Title:** Part C- Sotrovimab Gen2: 250 mg IM
#### Period
**Title:** Part A: Up to Week 24
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 22
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
##### Milestone
**Type:** Treatment Received
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 22
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 22
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
#### Period
**Title:** Part B: Up to Week 36
##### Withdraw
**Type:** Randomized, but did not receive treatment
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 84
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 83
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
##### Milestone
**Type:** Treatment Received
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 84
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 82
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 84
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 81
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
#### Period
**Title:** Part C: Up to Week 36
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 1
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 4
###### Reason
**Group ID:** FG005
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 79
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 78
##### Milestone
**Type:** Treatment Received
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 79
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 78
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 75
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 75
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 3
**Pre-Assignment Details:** Total of 354 participants (30 participants in Part A, 167 participants in Part B, 157 participants in Part C) were enrolled in the study.
**Recruitment Details:** Randomized, parallel group study conducted in non-hospitalized participants with mild to moderate Coronavirus Disease 2019 (COVID-19) who received Sotrovimab (VIR-7831) Generation1 (Gen 1) and Gen2.
**Has Results:** True