## Protocol Section
### Identification Module
**NCT ID:** NCT04401579

**Brief Title:** Adaptive COVID-19 Treatment Trial 2 (ACTT-2)

**Official Title:** A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults (ACTT-2)

#### Organization Study ID Info
**ID:** 20-0006 ACTT-2
#### Organization
**Class:** NIH
**Full Name:** National Institute of Allergy and Infectious Diseases (NIAID)
### Status Module
#### Completion Date
**Date:** 2020-07-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-03-14

**Type:** ACTUAL

**Last Update Submit Date:** 2022-03-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-07-31

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2021-04-26

**Type:** ACTUAL

**Results First Submit Date:** 2021-02-25

**Results First Submit QC Date:** 2021-04-22

#### Start Date
**Date:** 2020-05-08

**Type:** ACTUAL

**Status Verified Date:** 2020-04

#### Study First Post Date
**Date:** 2020-05-26
**Type:** ACTUAL
**Study First Submit Date:** 2020-05-22
**Study First Submit QC Date:** 2020-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** NIH

**Name:** National Institute of Allergy and Infectious Diseases (NIAID)

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** False

### Description Module

**Brief Summary:** ACTT-2 will evaluate the combination of baricitinib and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and oropharyngeal (OP) swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary outcome is time to recovery by Day 29.

**Detailed Description:** This study is an adaptive randomized double-blind placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. New arms can be introduced according to scientific and public health needs. There will be interim monitoring to allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. This adaptive platform is used to rapidly evaluate different therapeutics in a population of those hospitalized with moderate to severe COVID-19. The platform will provide a common framework sharing a similar population, design, endpoints, and safety oversight. New stages with new therapeutics can be introduced. One independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data in all stages to make recommendations about early study closure or changes to study arms.

ACTT-2 will evaluate the combination of baricitinib and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and oropharyngeal (OP) swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone.

All subjects will undergo a series of efficacy, safety, and laboratory assessments. Safety laboratory tests and blood (serum and plasma) research samples and oropharyngeal (OP) swabs will be obtained on Days 1 (prior to infusion) and Days 3, 5, 8, and 11 (while hospitalized). OP swabs and blood (serum only) plus safety laboratory tests will be collected on Day 15 and 29 (if the subject attends an in-person visit or are still hospitalized).

The primary outcome is time to recovery by Day 29. A key secondary outcome evaluates treatment-related improvements in the 8-point ordinal scale at Day 15. Each stage may prioritize different secondary endpoints for the purpose of multiple comparison analyses.

Contacts:

20-0006 Central Contact

Telephone: 1 (301) 7617948

Email: DMIDClinicalTrials@niaid.nih.gov

### Conditions Module

**Conditions:**

- COVID-19

**Keywords:**

- Adaptive

- COVID-19

- Efficacy

- Multicenter

- novel coronavirus

- Safety

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 1033

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.

**Intervention Names:**

- Drug: Remdesivir

- Drug: Baricitinib

**Label:** Remdesivir plus Baricitinib

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.

**Intervention Names:**

- Other: Placebo

- Drug: Remdesivir

**Label:** Remdesivir plus Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Remdesivir plus Placebo

**Description:** The matching Baricitinib placebo contains lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The coating for the placebo tablet is identical to that of the corresponding active tablet.

**Name:** Placebo

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Remdesivir plus Baricitinib

- Remdesivir plus Placebo

**Description:** Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.

**Name:** Remdesivir

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Remdesivir plus Baricitinib

**Description:** Baricitinib is a Janus kinase (JAK) inhibitor with the chemical name \[1-(ethylsulfonyl)-3-(4-(7Hpyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)azetidin-3-yl\]acetonitrile Each tablet contains 2 mg of baricitinib and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

**Name:** Baricitinib

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.

**Measure:** Time to Recovery

**Time Frame:** Day 1 through Day 29

**Description:** Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.

**Measure:** Time to Recovery by Race

**Time Frame:** Day 1 through Day 29

**Description:** Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.

**Measure:** Time to Recovery by Ethnicity

**Time Frame:** Day 1 through Day 29

**Description:** Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.

**Measure:** Time to Recovery by Sex

**Time Frame:** Day 1 through Day 29

#### Secondary Outcomes

**Description:** Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

**Measure:** Change From Baseline in Alanine Transaminase (ALT)

**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29

**Description:** Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

**Measure:** Change From Baseline in Aspartate Transaminase (AST)

**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29

**Description:** Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

**Measure:** Change From Baseline in Creatinine

**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29

**Description:** Blood to evaluate serum glucose was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

**Measure:** Change From Baseline in Glucose

**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29

**Description:** Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

**Measure:** Change From Baseline in Hemoglobin

**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29

**Description:** Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

**Measure:** Change From Baseline in Platelets

**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29

**Description:** Blood to evaluate INR was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

**Measure:** Change From Baseline in Prothrombin International Normalized Ratio (INR)

**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29

**Description:** Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

**Measure:** Change From Baseline in Total Bilirubin

**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29

**Description:** Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

**Measure:** Change From Baseline in White Blood Cell Count (WBC)

**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29

**Description:** BBlood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

**Measure:** Change From Baseline in Neutrophils

**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29

**Description:** Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

**Measure:** Change From Baseline in Lymphocytes

**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29

**Description:** Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

**Measure:** Change From Baseline in Monocytes

**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29

**Description:** Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

**Measure:** Change From Baseline in Basophils

**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29

**Description:** Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

**Measure:** Change From Baseline in Eosinophils

**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29

**Description:** The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome.

**Measure:** Change in National Early Warning Score (NEWS) From Baseline

**Time Frame:** Days 1, 3, 5, 8, 11, 15, 22, and 29

**Description:** Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.

**Measure:** Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)

**Time Frame:** Day 1 through Day 29

**Description:** An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.

**Measure:** Percentage of Participants Reporting Serious Adverse Events (SAEs)

**Time Frame:** Day 1 through Day 29

**Description:** Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.

**Measure:** Duration of Hospitalization

**Time Frame:** Day 1 through Day 29

**Description:** Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die

**Measure:** Duration of New Non-invasive Ventilation or High Flow Oxygen Use

**Time Frame:** Day 1 through Day 29

**Description:** Duration of new oxygen use was measured in days among participants who were not on oxygen at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die

**Measure:** Duration of New Oxygen Use

**Time Frame:** Day 1 through Day 29

**Description:** Duration of new ventilator or ECMO use was measured in days among participants who were not on a ventilator or ECMO at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die

**Measure:** Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use

**Time Frame:** Day 1 through Day 29

**Description:** Duration of oxygen use was measured in days among participants who were on oxygen in based, calculated in two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.

**Measure:** Duration of Oxygen Use

**Time Frame:** Day 1 through Day 29

**Description:** Participants may have been discontinued from investigational therapeutics due to discharge or death. The halting or slowing of the infusion for any reason was collected, as was missed doses in the series of 10 doses of Remdesivir, or in the 14 doses of Baricitinib/placebo.

**Measure:** Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics

**Time Frame:** Day 1 through Day 14

**Description:** The percentage of participants requiring new ventilator or ECMO use was determined as the percentage not on a ventilator or ECMO at baseline

**Measure:** Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use

**Time Frame:** Day 1 through Day 29

**Description:** The percentage of participants requiring new oxygen use was determined as the percentage of participants not requiring oxygen at baseline

**Measure:** Percentage of Participants Requiring New Oxygen Use

**Time Frame:** Day 1 through Day 29

**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. A positive change indicates a worsening and a negative change is an improvement.

**Measure:** Mean Change in the Ordinal Scale

**Time Frame:** Day 1, 3, 5, 8, 11, 15, 22, and 29

**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Data was imputed using last observation carried forward or worst possible score based on hospitalization status (2 if not hospitalized, 7 if hospitalized) when there was a change in hospitalization status since last score. Deaths were imputed as an 8.

**Measure:** Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15

**Time Frame:** Day 15

**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

**Measure:** Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1

**Time Frame:** Day 1

**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

**Measure:** Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3

**Time Frame:** Day 3

**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

**Measure:** Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5

**Time Frame:** Day 5

**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

**Measure:** Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8

**Time Frame:** Day 8

**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

**Measure:** Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11

**Time Frame:** Day 11

**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

**Measure:** Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22

**Time Frame:** Day 22

**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

**Measure:** Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29

**Time Frame:** Day 29

**Description:** The mortality rate was determined as the proportion of participants who died by study Day 15. The proportions reported are Kaplan-Meier estimates.

**Measure:** 14-day Participant Mortality

**Time Frame:** Day 1 through Day 15

**Description:** The mortality rate was determined as the proportion of participants who died by study Day 29. The proportions reported are Kaplan-Meier estimates.

**Measure:** 28-day Participant Mortality

**Time Frame:** Day 1 through Day 29

**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Time to improvement by at least one category was determined for each participant

**Measure:** Time to an Improvement of One Category Using an Ordinal Scale

**Time Frame:** Day 1 through Day 29

**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Time to improvement by at least two categories was determined for each participant

**Measure:** Time to an Improvement of Two Categories Using an Ordinal Scale

**Time Frame:** Day 1 through Day 29

**Description:** The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome. The time to discharge or a NEWS of less than or equal to 2 was determined for each participant.

**Measure:** Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First

**Time Frame:** Day 1 through Day 29

**Description:** Blood to evaluate CRP was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

**Measure:** Change From Baseline in C-reactive Protein (CRP)

**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29

**Description:** Blood to evaluate d-dimer concentration was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

**Measure:** Change From Baseline in D-dimer Concentration

**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Admitted to a hospital with symptoms suggestive of COVID-19.
2. Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
3. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
4. Male or non-pregnant female adult \> / = 18 years of age at time of enrollment.
5. Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen, as documented by either of the following:

   * PCR positive in sample collected \< 72 hours prior to randomization; OR
   * PCR positive in sample collected \>/= 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking \>24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
6. Illness of any duration, and at least one of the following:

   * Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
   * SpO2 \< / = 94% on room air, OR
   * Requiring supplemental oxygen, OR
   * Requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
7. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29.
8. Agrees to not participate in another clinical trial for the treatment of COVID-19 through Day 29.

Exclusion Criteria:

1. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \> 5 times the upper limit of normal.
2. Estimated glomerular filtration rate (eGFR) \< 30 ml/min or patient is receiving hemodialysis or hemofiltration at time of screening.
3. Neutropenia (absolute neutrophil count \<1000 cells/microliter) (\<1.0 x 103/microliter or \<1.0 GI/L).
4. Lymphopenia (absolute lymphocyte count \<200 cells/microliter) (\<0.20 x 103/microliter or \<0.20 GI/L)
5. Pregnancy or breast feeding.
6. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.
7. Allergy to any study medication.
8. Received three or more doses of remdesivir, including the loading dose, outside of the study under the EUA (or similar mechanism) for COVID-19.
9. Received convalescent plasma or intravenous immunoglobulin \[IVIg\]) for COVID-19, the current illness for which they are being enrolled.
10. Received small molecule tyrosine kinase inhibitors (e.g. baricitinib, imatibib, genfinitib), in the 1 week prior to screening
11. Received monoclonal antibodies targeting cytokines (e.g., TNF inhibitors, anti-interleukin-1 \[IL-1\], anti-IL-6 \[tocilizumab or sarilumab\]), or T-cells (e.g., abatacept) in the 4 weeks prior to screening.
12. Received monoclonal antibodies targeting B-cell (e.g., rituximab, and including any targeting multiple cell lines including B-cells) in the 3 months prior to screening.
13. Received other immunosuppressants in the 4 weeks prior to screening and in the judgement of the investigator, the risk of immunosuppression with baricitinib is larger than the risk of COVID-19.
14. Received \>/= 20 mg/day of prednisone or equivalent for \>/=14 consecutive days in the 4 weeks prior to screening.
15. Use of probenecid that cannot be discontinued at study enrollment.
16. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening required).
17. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
18. Have received any live vaccine (that is, live attenuated) within 4 weeks before screening, or intend to receive a live vaccine (or live attenuated) during the study. Note: Use of non-live (inactivated) vaccinations is allowed for all subjects.
19. Have a history of VTE (deep vein thrombosis \[DVT\] or pulmonary embolism \[PE\]) within 12 weeks prior to screening or have a history of recurrent (\>1) VTE (DVT/PE).
20. Immunocompromised patients, patients with a chronic medical condition, or those taking a medication that cannot be discontinued at enrollment, who, in the judgment of PI, are at increased risk for serious infections or other safety concerns given the study products.

**Maximum Age:** 99 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Birmingham

**Country:** United States

**Facility:** University of Alabama at Birmingham School of Medicine - Infectious Disease

**State:** Alabama

**Zip:** 35233

**Location 2:**

**City:** La Jolla

**Country:** United States

**Facility:** University of California San Diego Health - Jacobs Medical Center

**State:** California

**Zip:** 29037

**Location 3:**

**City:** Los Angeles

**Country:** United States

**Facility:** University of California Los Angeles Medical Center - Westwood Clinic

**State:** California

**Zip:** 90095

**Location 4:**

**City:** Orange

**Country:** United States

**Facility:** University of California Irvine Medical Center - Infectious Disease

**State:** California

**Zip:** 92868-3298

**Location 5:**

**City:** Palo Alto

**Country:** United States

**Facility:** VA Palo Alto Health Care System - Infectious Diseases

**State:** California

**Zip:** 94304-1207

**Location 6:**

**City:** Palo Alto

**Country:** United States

**Facility:** Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases

**State:** California

**Zip:** 94304-1503

**Location 7:**

**City:** Sacramento

**Country:** United States

**Facility:** University of California Davis Medical Center - Internal Medicine - Infectious Disease

**State:** California

**Zip:** 95817-1460

**Location 8:**

**City:** San Diego

**Country:** United States

**Facility:** Naval Medical Center San Diego - Infectious Disease Clinic

**State:** California

**Zip:** 92314

**Location 9:**

**City:** San Francisco

**Country:** United States

**Facility:** University of California San Francisco - Zuckerberg San Francisco General Hospital - Division of Human Immunodeficiency Virus, Infectious Disease, and Global Medicine

**State:** California

**Zip:** 94110-2859

**Location 10:**

**City:** West Hollywood

**Country:** United States

**Facility:** Cedars Sinai Medical Center

**State:** California

**Zip:** 90048-1804

**Location 11:**

**City:** Aurora

**Country:** United States

**Facility:** Eastern Colorado Health Care System

**State:** Colorado

**Zip:** 80045

**Location 12:**

**City:** Denver

**Country:** United States

**Facility:** Denver Health Division of Hospital Medicine - Main Campus

**State:** Colorado

**Zip:** 80204

**Location 13:**

**City:** Washington

**Country:** United States

**Facility:** Georgetown University Medical Center - Division of Infectious Diseases

**State:** District of Columbia

**Zip:** 20007

**Location 14:**

**City:** Gainesville

**Country:** United States

**Facility:** University of Florida Health - Shands Hospital - Division of Infectious Diseases and Global Medicine

**State:** Florida

**Zip:** 32610

**Location 15:**

**City:** Miami

**Country:** United States

**Facility:** University of Miami Miller School of Medicine - Infectious Diseases

**State:** Florida

**Zip:** 33136

**Location 16:**

**City:** Decatur

**Country:** United States

**Facility:** Emory Vaccine Center - The Hope Clinic

**State:** Georgia

**Zip:** 30030-1705

**Location 17:**

**City:** Decatur

**Country:** United States

**Facility:** Atlanta VA Medical Center - Infectious Diseases Clinic

**State:** Georgia

**Zip:** 30033

**Location 18:**

**City:** Chicago

**Country:** United States

**Facility:** Northwestern Hospital - Infectious Disease

**State:** Illinois

**Zip:** 60611-2908

**Location 19:**

**City:** Chicago

**Country:** United States

**Facility:** University of Illinois at Chicago College of Medicine - Division of Infectious Diseases

**State:** Illinois

**Zip:** 60612

**Location 20:**

**City:** Indianapolis

**Country:** United States

**Facility:** Indiana University School of Medicine - Infectious Diseases

**State:** Indiana

**Zip:** 46202

**Location 21:**

**City:** Kenner

**Country:** United States

**Facility:** Ochsner Medical Center - Kenner - Department of Infectious Diseases

**State:** Louisiana

**Zip:** 70065

**Location 22:**

**City:** New Orleans

**Country:** United States

**Facility:** Southeast Louisiana Veterans Health Care System (SLVHCS) - Section of Infectious Diseases

**State:** Louisiana

**Zip:** 70119

**Location 23:**

**City:** Baltimore

**Country:** United States

**Facility:** University of Maryland School of Medicine - Center for Vaccine Development - Baltimore

**State:** Maryland

**Zip:** 21201

**Location 24:**

**City:** Baltimore

**Country:** United States

**Facility:** Johns Hopkins Hospital - Medicine - Infectious Diseases

**State:** Maryland

**Zip:** 21287-0005

**Location 25:**

**City:** Bethesda

**Country:** United States

**Facility:** Walter Reed National Military Medical Center

**State:** Maryland

**Zip:** 20889

**Location 26:**

**City:** Bethesda

**Country:** United States

**Facility:** National Institutes of Health - Clinical Center, National Institute of Allergy and Infectious Diseases Laboratory Of Immunoregulation, Clinical Research Section

**State:** Maryland

**Zip:** 20892-1504

**Location 27:**

**City:** Boston

**Country:** United States

**Facility:** Massachusetts General Hospital - Infectious Diseases

**State:** Massachusetts

**Zip:** 02114-2621

**Location 28:**

**City:** Worcester

**Country:** United States

**Facility:** University of Massachusetts Medical School - Infectious Diseases and Immunology

**State:** Massachusetts

**Zip:** 01655-0002

**Location 29:**

**City:** Minneapolis

**Country:** United States

**Facility:** University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine

**State:** Minnesota

**Zip:** 55455-0341

**Location 30:**

**City:** Saint Louis

**Country:** United States

**Facility:** Saint Louis University - Center for Vaccine Development

**State:** Missouri

**Zip:** 63104-1015

**Location 31:**

**City:** Omaha

**Country:** United States

**Facility:** University of Nebraska Medical Center - Infectious Diseases

**State:** Nebraska

**Zip:** 68198-5400

**Location 32:**

**City:** Albuquerque

**Country:** United States

**Facility:** University of New Mexico Clinical and Translational Science Center

**State:** New Mexico

**Zip:** 87106

**Location 33:**

**City:** Bronx

**Country:** United States

**Facility:** Montefiore Medical Center - Infectious Diseases

**State:** New York

**Zip:** 10467-2401

**Location 34:**

**City:** New York

**Country:** United States

**Facility:** New York University School of Medicine - Langone Medical Center - Microbiology - Parasitology

**State:** New York

**Zip:** 10016

**Location 35:**

**City:** Rochester

**Country:** United States

**Facility:** University of Rochester Medical Center - Vaccine Research Unit

**State:** New York

**Zip:** 14642-0001

**Location 36:**

**City:** Durham

**Country:** United States

**Facility:** Duke Human Vaccine Institute - Duke Vaccine and Trials Unit

**State:** North Carolina

**Zip:** 27704

**Location 37:**

**City:** Fort Bragg

**Country:** United States

**Facility:** Womack Army Medical Center - Pulmonary and Respiratory Services

**State:** North Carolina

**Zip:** 28310

**Location 38:**

**City:** Portland

**Country:** United States

**Facility:** Kaiser Permanente Northwest - Center for Health Research

**State:** Oregon

**Zip:** 97227

**Location 39:**

**City:** Hershey

**Country:** United States

**Facility:** Penn State Health Milton S. Hershey Medical Center - Division of Infectious Diseases

**State:** Pennsylvania

**Zip:** 17033

**Location 40:**

**City:** Philadelphia

**Country:** United States

**Facility:** University of Pennsylvania Perelman School of Medicine - Penn Institute for Immunology

**State:** Pennsylvania

**Zip:** 19104-4863

**Location 41:**

**City:** Nashville

**Country:** United States

**Facility:** Vanderbilt University Medical Center - Infectious Diseases

**State:** Tennessee

**Zip:** 37232-0011

**Location 42:**

**City:** Dallas

**Country:** United States

**Facility:** Baylor Scott & White Health - Baylor University Medical Center - North Texas Infectious Disease Consultants

**State:** Texas

**Zip:** 75246

**Location 43:**

**City:** Dallas

**Country:** United States

**Facility:** University of Texas Southwestern Medical Center - Internal Medicine - Infectious Diseases

**State:** Texas

**Zip:** 75390-8884

**Location 44:**

**City:** Fort Sam Houston

**Country:** United States

**Facility:** Brooke Army Medical Center

**State:** Texas

**Zip:** 78234

**Location 45:**

**City:** Galveston

**Country:** United States

**Facility:** University of Texas Medical Branch - Division of Infectious Disease

**State:** Texas

**Zip:** 77555-0435

**Location 46:**

**City:** Houston

**Country:** United States

**Facility:** Baylor College of Medicine - Molecular Virology and Microbiology

**State:** Texas

**Zip:** 77030-3411

**Location 47:**

**City:** San Antonio

**Country:** United States

**Facility:** University of Texas Health Science Center at San Antonio - Infectious Diseases

**State:** Texas

**Zip:** 78229-3901

**Location 48:**

**City:** Salt Lake City

**Country:** United States

**Facility:** University of Utah - Infectious Diseases

**State:** Utah

**Zip:** 84132

**Location 49:**

**City:** Charlottesville

**Country:** United States

**Facility:** University of Virginia - Acute Care Surgery

**State:** Virginia

**Zip:** 22908-0816

**Location 50:**

**City:** Portsmouth

**Country:** United States

**Facility:** Naval Medical Center Portsmouth - Infectious Disease Division

**State:** Virginia

**Zip:** 23708

**Location 51:**

**City:** Kirkland

**Country:** United States

**Facility:** EvergreenHealth Infectious Disease Service

**State:** Washington

**Zip:** 98034

**Location 52:**

**City:** Spokane

**Country:** United States

**Facility:** Providence Sacred Heart Medical Center

**State:** Washington

**Zip:** 99204

**Location 53:**

**City:** Tacoma

**Country:** United States

**Facility:** Madigan Army Medical Center - Infectious Disease Clinic

**State:** Washington

**Zip:** 98431

**Location 54:**

**City:** Copenhagen

**Country:** Denmark

**Facility:** University of Copenhagen - Centre of Excellence for Health, Immunity and Infections (CHIP) - Department of Infectious Diseases

**Zip:** 2100

**Location 55:**

**City:** Tokyo

**Country:** Japan

**Facility:** National Center for Global Health and Medicine Hospital - Disease Control and Prevention Center

**Zip:** 162-8655

**Location 56:**

**City:** Bundang-gu Seongnam-si

**Country:** Korea, Republic of

**Facility:** Seoul National University Bundang Hospital - Division of Infectious Diseases

**Zip:** 13620

**Location 57:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Seoul National University Hospital

**Zip:** 03080

**Location 58:**

**City:** Mexico City

**Country:** Mexico

**Facility:** Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán - Departamento de Infectologia

**Zip:** 14080

**Location 59:**

**City:** Mexico City

**Country:** Mexico

**Facility:** Instituto Nacional de Enfermedades Respiratorias (INER) - Ismael Cosío Villegas

**Zip:** 14080

**Location 60:**

**City:** Singapore

**Country:** Singapore

**Facility:** National University Health System - Division of Infectious Diseases

**Zip:** 119228

**Location 61:**

**City:** Singapore

**Country:** Singapore

**Facility:** National Centre for Infectious Diseases (NCID)

**Zip:** 308442

**Location 62:**

**City:** Singapore

**Country:** Singapore

**Facility:** Changi General Hospital - Clinical Trials and Research Unit (CTRU)

**Zip:** 529889

**Location 63:**

**City:** Singapore

**Country:** Singapore

**Facility:** Ng Teng Fong General Hospital - Infectious Disease Service

**Zip:** 609606

**Location 64:**

**City:** Barcelona

**Country:** Spain

**Facility:** Hospital Clinic Barcelona, Servicio de Salud Internacional

**State:** Cataluña

**Zip:** 08036

**Location 65:**

**City:** Barcelona

**Country:** Spain

**Facility:** Hospital Germans Trias i Pujol - Servei Malalties Infeccioses

**State:** Cataluña

**Zip:** 08916

**Location 66:**

**City:** Madrid

**Country:** Spain

**Facility:** Hospital Clinico San Carlos - Enfermedades Infecciosas

**Zip:** 28040

**Location 67:**

**City:** Brighton

**Country:** United Kingdom

**Facility:** Royal Sussex County Hospital - Department of Intensive Care Medicine

**Location 68:**

**City:** City Of London

**Country:** United Kingdom

**Facility:** Saint Thomas' Hospital - Directorate of Infection

**Location 69:**

**City:** Leeds

**Country:** United Kingdom

**Facility:** St. James's University Hospital - Infectious Diseases

**Location 70:**

**City:** Newcastle Upon Tyne

**Country:** United Kingdom

**Facility:** Royal Victoria Infirmary - Department of Infectious Diseases

**Location 71:**

**City:** Oxford

**Country:** United Kingdom

**Facility:** John Radcliffe Hospital

### References Module

#### References

**Citation:** Kramer A, Prinz C, Fichtner F, Fischer AL, Thieme V, Grundeis F, Spagl M, Seeber C, Piechotta V, Metzendorf MI, Golinski M, Moerer O, Stephani C, Mikolajewska A, Kluge S, Stegemann M, Laudi S, Skoetz N. Janus kinase inhibitors for the treatment of COVID-19. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD015209. doi: 10.1002/14651858.CD015209.

**PMID:** 35695334

**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

**Citation:** Kalil AC, Patterson TF, Mehta AK, Tomashek KM, Wolfe CR, Ghazaryan V, Marconi VC, Ruiz-Palacios GM, Hsieh L, Kline S, Tapson V, Iovine NM, Jain MK, Sweeney DA, El Sahly HM, Branche AR, Regalado Pineda J, Lye DC, Sandkovsky U, Luetkemeyer AF, Cohen SH, Finberg RW, Jackson PEH, Taiwo B, Paules CI, Arguinchona H, Erdmann N, Ahuja N, Frank M, Oh MD, Kim ES, Tan SY, Mularski RA, Nielsen H, Ponce PO, Taylor BS, Larson L, Rouphael NG, Saklawi Y, Cantos VD, Ko ER, Engemann JJ, Amin AN, Watanabe M, Billings J, Elie MC, Davey RT, Burgess TH, Ferreira J, Green M, Makowski M, Cardoso A, de Bono S, Bonnett T, Proschan M, Deye GA, Dempsey W, Nayak SU, Dodd LE, Beigel JH; ACTT-2 Study Group Members. Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19. N Engl J Med. 2021 Mar 4;384(9):795-807. doi: 10.1056/NEJMoa2031994. Epub 2020 Dec 11.

**PMID:** 33306283

**Citation:** Azzi Y, Bartash R, Scalea J, Loarte-Campos P, Akalin E. COVID-19 and Solid Organ Transplantation: A Review Article. Transplantation. 2021 Jan 1;105(1):37-55. doi: 10.1097/TP.0000000000003523.

**PMID:** 33148977

## Document Section

### Large Document Module

#### Large Docs

- Date: 2020-05-25

- Filename: Prot_002.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 1939179

- Type Abbrev: Prot

- Upload Date: 2021-02-25T13:00

- Date: 2020-08-20

- Filename: SAP_003.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 4745170

- Type Abbrev: SAP

- Upload Date: 2021-02-25T13:02

- Date: 2020-06-04

- Filename: ICF_001.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 295917

- Type Abbrev: ICF

- Upload Date: 2020-08-11T09:35

## 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: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: NaAg

- Name: Natriuretic Agents

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: HB

- Name: Herbal and Botanical

### Intervention Browse Module - Browse Leaves

- ID: M5524

- Name: Carboxymethylcellulose Sodium

- Relevance: LOW

- As Found: Unknown

- ID: M11342

- Name: Mannitol

- Relevance: LOW

- As Found: Unknown

- ID: M198097

- Name: Pyrazole

- Relevance: LOW

- As Found: Unknown

- ID: M6263

- Name: Coal Tar

- Relevance: LOW

- As Found: Unknown

- ID: M3777

- Name: Ethanol

- Relevance: LOW

- As Found: Unknown

- ID: M341633

- Name: GS-441524

- Relevance: LOW

- As Found: Unknown

- ID: M223520

- Name: Titanium dioxide

- Relevance: LOW

- As Found: Unknown

- ID: M341627

- Name: Remdesivir

- Relevance: HIGH

- As Found: Path

- ID: M107438

- Name: Betadex

- Relevance: LOW

- As Found: Unknown

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: T404

- Name: Lecithin

- Relevance: LOW

- As Found: Unknown

- ID: T294

- Name: Soy Bean

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000606551

- Term: Remdesivir

### Misc Info Module

#### Submission Tracking

##### First MCP Info

###### Post Date

- Date: 2021-03-09

- Type: ACTUAL

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.

#### Event Groups

**Group ID:** EG000

**Title:** Remdesivir Plus Baricitinib

**Deaths Num Affected:** 24

**Deaths Num At Risk:** 515

**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.

**ID:** EG000

**Other Num Affected:** 147

**Other Num at Risk:** 507

**Serious Number Affected:** 88

**Serious Number At Risk:** 507

**Title:** Remdesivir Plus Baricitinib

**Group ID:** EG001

**Title:** Remdesivir Plus Placebo

**Deaths Num Affected:** 37

**Deaths Num At Risk:** 518

**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.

**ID:** EG001

**Other Num Affected:** 164

**Other Num at Risk:** 509

**Serious Number Affected:** 109

**Serious Number At Risk:** 509

**Title:** Remdesivir Plus Placebo

**Frequency Threshold:** 5

#### Other Events

**Term:** Glomerular filtration rate decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (23.0)

**Term:** Hyperglycaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (23.0)

**Term:** Haemoglobin decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (23.0)

**Term:** Lymphocyte count decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (23.0)

**Term:** Anaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

**Term:** Blood glucose increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (23.0)

**Term:** Acute kidney injury

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (23.0)

#### Serious Events

**Term:** Respiratory failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 29

**Num At Risk:** 507

**Num Events:** 30

**Group ID:** EG001

**Num Affected:** 37

**Num At Risk:** 509

**Num Events:** 38

**Term:** Acute respiratory failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 18

**Num At Risk:** 507

**Num Events:** 18

**Group ID:** EG001

**Num Affected:** 16

**Num At Risk:** 509

**Num Events:** 16

**Term:** Acute kidney injury

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 507

**Num Events:** 5

**Group ID:** EG001

**Num Affected:** 11

**Num At Risk:** 509

**Num Events:** 11

**Term:** Acute respiratory distress syndrome

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 507

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 10

**Num At Risk:** 509

**Num Events:** 10

**Term:** Septic shock

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 507

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 8

**Num At Risk:** 509

**Num Events:** 8

**Term:** Hypotension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 507

**Num Events:** 6

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 509

**Num Events:** 5

**Term:** Respiratory distress

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 7

**Num At Risk:** 507

**Num Events:** 8

**Group ID:** EG001

**Num Affected:** 7

**Num At Risk:** 509

**Num Events:** 7

**Term:** Pneumonia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 507

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 8

**Num At Risk:** 509

**Num Events:** 8

**Term:** Multiple organ dysfunction syndrome

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 507

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 509

**Num Events:** 6

**Term:** Pulmonary embolism

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 507

**Num Events:** 5

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Hypoxia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 507

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 509

**Num Events:** 4

**Term:** Shock

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 507

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 509

**Num Events:** 4

**Term:** Cardiac arrest

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 507

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 509

**Num Events:** 3

**Term:** Dyspnoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 507

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 509

**Num Events:** 4

**Term:** Pneumothorax

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 509

**Num Events:** 4

**Term:** Sepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 507

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 509

**Num Events:** 5

**Term:** Renal failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 509

**Num Events:** 5

**Term:** Pulseless electrical activity

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 507

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Anaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 509

**Num Events:** 2

**Term:** Cerebrovascular accident

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 509

**Num Events:** 2

**Term:** Encephalopathy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 509

**Num Events:** 2

**Term:** Alanine aminotransferase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 509

**Num Events:** 3

**Term:** Chest pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 507

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Cardio-respiratory arrest

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Deep vein thrombosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Respiratory arrest

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Aspartate aminotransferase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 509

**Num Events:** 2

**Term:** Asthenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Cardiac failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Dehydration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Distributive shock

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Gastrointestinal haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Guillain-Barre syndrome

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Intervertebral discitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Leukopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Lower respiratory tract infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Lymphocyte count decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Nervous system disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Non-cardiac chest pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Pneumonia aspiration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Procedural hypotension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Prostatic abscess

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Sickle cell anaemia with crisis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Sinus tachycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Thrombophlebitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Urinary tract infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Visual impairment

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Term:** Abdominal pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Acidosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Aortic valve stenosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Arrhythmia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Aspergillus infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Atrial fibrillation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Atrioventricular block

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Blood creatinine increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Blood glucose decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Bradycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Diabetic ketoacidosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Embolism venous

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Endotracheal intubation complication

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 2

**Term:** Fall

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Haematoma muscle

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Haemoglobin decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Haemorrhage intracranial

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Hepatic haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Hepatitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Hyperkalaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Hypersensitivity

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Hypoglycaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Injection site induration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Left ventricular failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Lung abscess

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Lymphopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Metabolic acidosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Oedema peripheral

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Overdose

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Pneumomediastinum

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Presyncope

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Right ventricular dysfunction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Subdural haematoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Tachypnoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 509

**Num Events:** 2

**Term:** Troponin increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Urosepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 507

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 509

**Num Events:** 1

**Term:** Lipoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (23.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 507

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 509

**Time Frame:** Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 515

**Group ID:** BG001

**Value:** 518

**Group ID:** BG002

**Value:** 1033

**Units:** Participants

### Group

**ID:** BG000

**Title:** Remdesivir Plus Baricitinib

**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.

### Group

**ID:** BG001

**Title:** Remdesivir Plus Placebo

**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 368

#### Measurement

**Group ID:** BG001

**Value:** 360

#### Measurement

**Group ID:** BG002

**Value:** 728

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 147

#### Measurement

**Group ID:** BG001

**Value:** 158

#### Measurement

**Group ID:** BG002

**Value:** 305

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 15.4

**Value:** 55.0

#### Measurement

**Group ID:** BG001

**Spread:** 16.0

**Value:** 55.8

#### Measurement

**Group ID:** BG002

**Spread:** 15.7

**Value:** 55.4

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 196

#### Measurement

**Group ID:** BG001

**Value:** 185

#### Measurement

**Group ID:** BG002

**Value:** 381

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 319

#### Measurement

**Group ID:** BG001

**Value:** 333

#### Measurement

**Group ID:** BG002

**Value:** 652

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 263

#### Measurement

**Group ID:** BG001

**Value:** 268

#### Measurement

**Group ID:** BG002

**Value:** 531

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 246

#### Measurement

**Group ID:** BG001

**Value:** 240

#### Measurement

**Group ID:** BG002

**Value:** 486

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 10

#### Measurement

**Group ID:** BG002

**Value:** 16

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 10

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

#### Measurement

**Group ID:** BG000

**Value:** 49

#### Measurement

**Group ID:** BG001

**Value:** 52

#### Measurement

**Group ID:** BG002

**Value:** 101

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 11

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 77

#### Measurement

**Group ID:** BG001

**Value:** 79

#### Measurement

**Group ID:** BG002

**Value:** 156

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 251

#### Measurement

**Group ID:** BG001

**Value:** 245

#### Measurement

**Group ID:** BG002

**Value:** 496

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 132

#### Measurement

**Group ID:** BG001

**Value:** 127

#### Measurement

**Group ID:** BG002

**Value:** 259

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 11

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 22

**Class Title:** South Korea

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 22

#### Measurement

**Group ID:** BG002

**Value:** 44

**Class Title:** Singapore

#### Measurement

**Group ID:** BG000

**Value:** 441

#### Measurement

**Group ID:** BG001

**Value:** 444

#### Measurement

**Group ID:** BG002

**Value:** 885

**Class Title:** United States

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Class Title:** Japan

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 9

**Class Title:** Denmark

#### Measurement

**Group ID:** BG000

**Value:** 35

#### Measurement

**Group ID:** BG001

**Value:** 33

#### Measurement

**Group ID:** BG002

**Value:** 68

**Class Title:** Mexico

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Class Title:** United Kingdom

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 3

**Class Title:** Spain

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 176

#### Measurement

**Group ID:** BG001

**Value:** 191

#### Measurement

**Group ID:** BG002

**Value:** 367

**Category Title:** Severe Disease Severity

#### Measurement

**Group ID:** BG000

**Value:** 339

#### Measurement

**Group ID:** BG001

**Value:** 327

#### Measurement

**Group ID:** BG002

**Value:** 666

**Category Title:** Moderate Disease Severity

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 6
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
### Measure 7
**Description:** Severe disease was defined as hospitalized, requiring extracorporeal membrane oxygenation (ECMO), invasive or non-invasive ventilation, or high flow oxygen Moderate disease was defined as hospitalized, requiring supplemental oxygen or not requiring supplemental oxygen.

Disease severity was as defined at the time or randomization.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Disease severity
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** LTE60
**Restrictive Agreement:** True
### Point of Contact
**Email:** jbeigel@niaid.nih.gov
**Organization:** NIAID
**Phone:** 3014519881
**Title:** John Beigel, MD
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 1.00
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.31
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.047
**P-Value Comment:** 
**Parameter Type:** Cox Proportional Hazard
**Parameter Value:** 1.15
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### 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
#### Analysis
**CI Lower Limit:** -12
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Risk Difference (RD)
**Parameter Value:** -6
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 18
#### Analysis
**CI Lower Limit:** -10
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Risk Difference (RD)
**Parameter Value:** -5
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### 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
#### Analysis
**CI Lower Limit:** 1.01
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.57
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.44
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 1.26
**Statistical Comment:** 
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** 
### Outcome Measure 29
### Outcome Measure 30
### Outcome Measure 31
### Outcome Measure 32
### Outcome Measure 33
### Outcome Measure 34
### Outcome Measure 35
### Outcome Measure 36
### Outcome Measure 37
### Outcome Measure 38
#### Analysis
**CI Lower Limit:** 1.06
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.39
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.002
**P-Value Comment:** 
**Parameter Type:** Cox Proportional Hazard
**Parameter Value:** 1.21
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 39
#### Analysis
**CI Lower Limit:** 1.05
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.38
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.005
**P-Value Comment:** 
**Parameter Type:** Cox Proportional Hazard
**Parameter Value:** 1.20
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 40
#### Analysis
**CI Lower Limit:** 1.07
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.44
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.003
**P-Value Comment:** 
**Parameter Type:** Cox Proportional Hazard
**Parameter Value:** 1.24
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 41
### Outcome Measure 42
### Outcome Measure 43
#### Analysis
**CI Lower Limit:** 0.73
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.68
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** This analysis is for Asian participants.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Cox Proportional Hazard
**Parameter Value:** 1.11
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.75
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.50
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** This analysis is for Black or African American participants.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Cox Proportional Hazard
**Parameter Value:** 1.06
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.93
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.37
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** This analysis is for White participants.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Cox Proportional Hazard
**Parameter Value:** 1.13
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 1.03
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.74
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** This analysis is for Race of Other participants.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Cox Proportional Hazard
**Parameter Value:** 1.34
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 44
#### Analysis
**CI Lower Limit:** 1.08
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.60
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** This analysis is for Not Hispanic or Latino participants
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Cox Proportional Hazard
**Parameter Value:** 1.31
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.89
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.31
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** This analysis is for Hispanic or Latino participants.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Cox Proportional Hazard
**Parameter Value:** 1.08
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 45
#### Analysis
**CI Lower Limit:** 1.04
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.46
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** This analysis is for Male participants.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Cox Proportional Hazard
**Parameter Value:** 1.23
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.85
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.32
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** This analysis is for Female participants.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Cox Proportional Hazard
**Parameter Value:** 1.06
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6.0
- **Spread:** 
- **Upper Limit:** 8.0
- **Value:** 7.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7.0
- **Spread:** 
- **Upper Limit:** 9.0
- **Value:** 8.0
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 37.1
- **Upper Limit:** 
- **Value:** 3.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 30.1
- **Upper Limit:** 
- **Value:** 2.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 491
- **Group ID:** OG001
- **Value:** 491
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 104.4
- **Upper Limit:** 
- **Value:** 16.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 40.9
- **Upper Limit:** 
- **Value:** 8.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 407
- **Group ID:** OG001
- **Value:** 406
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 45.2
- **Upper Limit:** 
- **Value:** 7.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 46.9
- **Upper Limit:** 
- **Value:** 7.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 268
- **Group ID:** OG001
- **Value:** 284
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 37.5
- **Upper Limit:** 
- **Value:** 0.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 70.2
- **Upper Limit:** 
- **Value:** 7.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 187
- **Group ID:** OG001
- **Value:** 201
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 61.5
- **Upper Limit:** 
- **Value:** 5.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 55.1
- **Upper Limit:** 
- **Value:** 3.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 250
- **Group ID:** OG001
- **Value:** 270
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 43.0
- **Upper Limit:** 
- **Value:** -5.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 116.1
- **Upper Limit:** 
- **Value:** 2.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 256
- **Group ID:** OG001
- **Value:** 255
**Units:** Participants
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 72.4
- **Upper Limit:** 
- **Value:** 3.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 126.4
- **Upper Limit:** 
- **Value:** 2.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 486
- **Group ID:** OG001
- **Value:** 487
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 413.1
- **Upper Limit:** 
- **Value:** 27.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 48.3
- **Upper Limit:** 
- **Value:** 2.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 404
- **Group ID:** OG001
- **Value:** 403
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 38.4
- **Upper Limit:** 
- **Value:** -5.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 42.3
- **Upper Limit:** 
- **Value:** -4.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 265
- **Group ID:** OG001
- **Value:** 282
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 46.4
- **Upper Limit:** 
- **Value:** -10.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 208.3
- **Upper Limit:** 
- **Value:** 6.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 185
- **Group ID:** OG001
- **Value:** 200
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 110.1
- **Upper Limit:** 
- **Value:** -6.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 91.0
- **Upper Limit:** 
- **Value:** -3.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 246
- **Group ID:** OG001
- **Value:** 266
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 46.7
- **Upper Limit:** 
- **Value:** -17.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 291.1
- **Upper Limit:** 
- **Value:** 2.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 251
- **Group ID:** OG001
- **Value:** 251
**Units:** Participants
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.465
- **Upper Limit:** 
- **Value:** -0.036
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.362
- **Upper Limit:** 
- **Value:** -0.019
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 494
- **Group ID:** OG001
- **Value:** 495
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.475
- **Upper Limit:** 
- **Value:** -0.078
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.556
- **Upper Limit:** 
- **Value:** 0.001
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 412
- **Group ID:** OG001
- **Value:** 410
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.570
- **Upper Limit:** 
- **Value:** -0.082
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.958
- **Upper Limit:** 
- **Value:** 0.129
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 270
- **Group ID:** OG001
- **Value:** 285
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.798
- **Upper Limit:** 
- **Value:** -0.055
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.037
- **Upper Limit:** 
- **Value:** 0.194
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 190
- **Group ID:** OG001
- **Value:** 202
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.714
- **Upper Limit:** 
- **Value:** -0.042
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.662
- **Upper Limit:** 
- **Value:** 0.094
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 254
- **Group ID:** OG001
- **Value:** 273
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.678
- **Upper Limit:** 
- **Value:** -0.034
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.511
- **Upper Limit:** 
- **Value:** 0.033
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 260
- **Group ID:** OG001
- **Value:** 257
**Units:** Participants
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 56.4
- **Upper Limit:** 
- **Value:** -17.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 54.0
- **Upper Limit:** 
- **Value:** -6.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 493
- **Group ID:** OG001
- **Value:** 493
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 59.7
- **Upper Limit:** 
- **Value:** -15.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 58.4
- **Upper Limit:** 
- **Value:** -1.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 412
- **Group ID:** OG001
- **Value:** 409
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 78.9
- **Upper Limit:** 
- **Value:** -16.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 73.7
- **Upper Limit:** 
- **Value:** 5.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 270
- **Group ID:** OG001
- **Value:** 284
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 72.3
- **Upper Limit:** 
- **Value:** -8.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 66.2
- **Upper Limit:** 
- **Value:** 1.2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 190
- **Group ID:** OG001
- **Value:** 203
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 69.8
- **Upper Limit:** 
- **Value:** -11.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 68.3
- **Upper Limit:** 
- **Value:** 0.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 252
- **Group ID:** OG001
- **Value:** 271
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 66.5
- **Upper Limit:** 
- **Value:** -4.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 60.3
- **Upper Limit:** 
- **Value:** -2.2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 257
- **Group ID:** OG001
- **Value:** 256
**Units:** Participants
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.05
- **Upper Limit:** 
- **Value:** -0.46
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.51
- **Upper Limit:** 
- **Value:** -0.34
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 493
- **Group ID:** OG001
- **Value:** 494
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.23
- **Upper Limit:** 
- **Value:** -0.62
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.13
- **Upper Limit:** 
- **Value:** -0.64
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 410
- **Group ID:** OG001
- **Value:** 409
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.61
- **Upper Limit:** 
- **Value:** -0.93
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.47
- **Upper Limit:** 
- **Value:** -1.08
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 270
- **Group ID:** OG001
- **Value:** 284
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.85
- **Upper Limit:** 
- **Value:** -1.29
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.88
- **Upper Limit:** 
- **Value:** -1.62
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 189
- **Group ID:** OG001
- **Value:** 199
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.87
- **Upper Limit:** 
- **Value:** -0.96
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.38
- **Upper Limit:** 
- **Value:** -1.12
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 253
- **Group ID:** OG001
- **Value:** 267
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.87
- **Upper Limit:** 
- **Value:** -0.54
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.25
- **Upper Limit:** 
- **Value:** -0.77
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 260
- **Group ID:** OG001
- **Value:** 254
**Units:** Participants
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 54.0
- **Upper Limit:** 
- **Value:** 55.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 51.6
- **Upper Limit:** 
- **Value:** 52.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 493
- **Group ID:** OG001
- **Value:** 494
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 87.8
- **Upper Limit:** 
- **Value:** 116.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 86.9
- **Upper Limit:** 
- **Value:** 106.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 410
- **Group ID:** OG001
- **Value:** 409
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 137.4
- **Upper Limit:** 
- **Value:** 197.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 128.5
- **Upper Limit:** 
- **Value:** 158.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 269
- **Group ID:** OG001
- **Value:** 284
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 156.0
- **Upper Limit:** 
- **Value:** 229.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 146.4
- **Upper Limit:** 
- **Value:** 145.7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 189
- **Group ID:** OG001
- **Value:** 199
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 158.8
- **Upper Limit:** 
- **Value:** 175.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 134.9
- **Upper Limit:** 
- **Value:** 111.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 252
- **Group ID:** OG001
- **Value:** 267
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 95.8
- **Upper Limit:** 
- **Value:** 16.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 107.9
- **Upper Limit:** 
- **Value:** 36.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 260
- **Group ID:** OG001
- **Value:** 254
**Units:** Participants
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.13
- **Upper Limit:** 
- **Value:** -0.03
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.59
- **Upper Limit:** 
- **Value:** 0.05
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 447
- **Group ID:** OG001
- **Value:** 439
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.25
- **Upper Limit:** 
- **Value:** 0.02
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.65
- **Upper Limit:** 
- **Value:** 0.08
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 360
- **Group ID:** OG001
- **Value:** 370
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.96
- **Upper Limit:** 
- **Value:** 0.01
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.98
- **Upper Limit:** 
- **Value:** 0.08
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 244
- **Group ID:** OG001
- **Value:** 250
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.65
- **Upper Limit:** 
- **Value:** 0.04
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.04
- **Upper Limit:** 
- **Value:** 0.03
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 162
- **Group ID:** OG001
- **Value:** 175
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.25
- **Upper Limit:** 
- **Value:** -0.04
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.91
- **Upper Limit:** 
- **Value:** -0.08
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 222
- **Group ID:** OG001
- **Value:** 241
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.55
- **Upper Limit:** 
- **Value:** -0.12
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.99
- **Upper Limit:** 
- **Value:** -0.03
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 232
- **Group ID:** OG001
- **Value:** 232
**Units:** Participants
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.32
- **Upper Limit:** 
- **Value:** -0.06
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.43
- **Upper Limit:** 
- **Value:** -0.01
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 490
- **Group ID:** OG001
- **Value:** 491
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.37
- **Upper Limit:** 
- **Value:** -0.04
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.42
- **Upper Limit:** 
- **Value:** 0.01
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 407
- **Group ID:** OG001
- **Value:** 405
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.41
- **Upper Limit:** 
- **Value:** -0.06
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.66
- **Upper Limit:** 
- **Value:** 0.01
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 268
- **Group ID:** OG001
- **Value:** 284
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.43
- **Upper Limit:** 
- **Value:** -0.08
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.19
- **Upper Limit:** 
- **Value:** 0.08
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 187
- **Group ID:** OG001
- **Value:** 201
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.37
- **Upper Limit:** 
- **Value:** -0.10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.20
- **Upper Limit:** 
- **Value:** 0.08
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 250
- **Group ID:** OG001
- **Value:** 270
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.36
- **Upper Limit:** 
- **Value:** -0.10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.91
- **Upper Limit:** 
- **Value:** 0.01
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 256
- **Group ID:** OG001
- **Value:** 254
**Units:** Participants
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.020
- **Upper Limit:** 
- **Value:** -0.831
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.588
- **Upper Limit:** 
- **Value:** -0.037
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 493
- **Group ID:** OG001
- **Value:** 494
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.399
- **Upper Limit:** 
- **Value:** -0.276
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.238
- **Upper Limit:** 
- **Value:** 0.392
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 410
- **Group ID:** OG001
- **Value:** 409
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.006
- **Upper Limit:** 
- **Value:** 0.663
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.536
- **Upper Limit:** 
- **Value:** 1.606
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 270
- **Group ID:** OG001
- **Value:** 284
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.683
- **Upper Limit:** 
- **Value:** 1.869
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.419
- **Upper Limit:** 
- **Value:** 2.938
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 189
- **Group ID:** OG001
- **Value:** 199
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.125
- **Upper Limit:** 
- **Value:** 0.694
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.741
- **Upper Limit:** 
- **Value:** 2.162
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 253
- **Group ID:** OG001
- **Value:** 267
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.532
- **Upper Limit:** 
- **Value:** -0.364
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.176
- **Upper Limit:** 
- **Value:** 0.712
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 260
- **Group ID:** OG001
- **Value:** 254
**Units:** Participants
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.234
- **Upper Limit:** 
- **Value:** -1.925
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.787
- **Upper Limit:** 
- **Value:** -0.333
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 488
- **Group ID:** OG001
- **Value:** 493
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8.092
- **Upper Limit:** 
- **Value:** -1.334
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.630
- **Upper Limit:** 
- **Value:** -0.204
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 408
- **Group ID:** OG001
- **Value:** 404
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9.695
- **Upper Limit:** 
- **Value:** -0.813
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.665
- **Upper Limit:** 
- **Value:** 1.139
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 268
- **Group ID:** OG001
- **Value:** 282
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8.881
- **Upper Limit:** 
- **Value:** -0.046
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.152
- **Upper Limit:** 
- **Value:** 1.847
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 186
- **Group ID:** OG001
- **Value:** 196
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.844
- **Upper Limit:** 
- **Value:** -1.192
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.995
- **Upper Limit:** 
- **Value:** 1.414
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 249
- **Group ID:** OG001
- **Value:** 267
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.735
- **Upper Limit:** 
- **Value:** -1.708
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.205
- **Upper Limit:** 
- **Value:** -0.656
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 257
- **Group ID:** OG001
- **Value:** 253
**Units:** Participants
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.290
- **Upper Limit:** 
- **Value:** 0.503
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.844
- **Upper Limit:** 
- **Value:** 0.074
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 488
- **Group ID:** OG001
- **Value:** 493
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.540
- **Upper Limit:** 
- **Value:** 0.620
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.838
- **Upper Limit:** 
- **Value:** 0.205
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 408
- **Group ID:** OG001
- **Value:** 404
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.094
- **Upper Limit:** 
- **Value:** 0.515
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.366
- **Upper Limit:** 
- **Value:** 0.304
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 268
- **Group ID:** OG001
- **Value:** 282
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.204
- **Upper Limit:** 
- **Value:** 0.541
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.709
- **Upper Limit:** 
- **Value:** 0.409
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 186
- **Group ID:** OG001
- **Value:** 196
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.579
- **Upper Limit:** 
- **Value:** 0.687
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.684
- **Upper Limit:** 
- **Value:** 0.718
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 249
- **Group ID:** OG001
- **Value:** 267
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.293
- **Upper Limit:** 
- **Value:** 0.653
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.996
- **Upper Limit:** 
- **Value:** 0.927
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 257
- **Group ID:** OG001
- **Value:** 253
**Units:** Participants
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.810
- **Upper Limit:** 
- **Value:** 0.004
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.750
- **Upper Limit:** 
- **Value:** 0.062
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 487
- **Group ID:** OG001
- **Value:** 493
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.053
- **Upper Limit:** 
- **Value:** 0.094
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.013
- **Upper Limit:** 
- **Value:** 0.153
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 408
- **Group ID:** OG001
- **Value:** 404
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.948
- **Upper Limit:** 
- **Value:** 0.105
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.758
- **Upper Limit:** 
- **Value:** 0.279
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 268
- **Group ID:** OG001
- **Value:** 282
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.439
- **Upper Limit:** 
- **Value:** 0.210
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.512
- **Upper Limit:** 
- **Value:** 0.378
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 186
- **Group ID:** OG001
- **Value:** 196
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.591
- **Upper Limit:** 
- **Value:** 0.256
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.606
- **Upper Limit:** 
- **Value:** 0.329
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 249
- **Group ID:** OG001
- **Value:** 267
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.434
- **Upper Limit:** 
- **Value:** 0.108
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.745
- **Upper Limit:** 
- **Value:** 0.212
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 257
- **Group ID:** OG001
- **Value:** 253
**Units:** Participants
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.039
- **Upper Limit:** 
- **Value:** 0.000
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.050
- **Upper Limit:** 
- **Value:** 0.001
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 483
- **Group ID:** OG001
- **Value:** 492
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.070
- **Upper Limit:** 
- **Value:** 0.007
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.044
- **Upper Limit:** 
- **Value:** 0.006
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 402
- **Group ID:** OG001
- **Value:** 402
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.055
- **Upper Limit:** 
- **Value:** 0.011
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.075
- **Upper Limit:** 
- **Value:** 0.017
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 265
- **Group ID:** OG001
- **Value:** 281
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.063
- **Upper Limit:** 
- **Value:** 0.014
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.063
- **Upper Limit:** 
- **Value:** 0.022
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 185
- **Group ID:** OG001
- **Value:** 195
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.085
- **Upper Limit:** 
- **Value:** 0.026
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.104
- **Upper Limit:** 
- **Value:** 0.037
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 247
- **Group ID:** OG001
- **Value:** 265
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.045
- **Upper Limit:** 
- **Value:** 0.022
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.092
- **Upper Limit:** 
- **Value:** 0.036
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 257
- **Group ID:** OG001
- **Value:** 250
**Units:** Participants
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.135
- **Upper Limit:** 
- **Value:** 0.050
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.201
- **Upper Limit:** 
- **Value:** 0.039
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 484
- **Group ID:** OG001
- **Value:** 492
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.402
- **Upper Limit:** 
- **Value:** 0.104
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.257
- **Upper Limit:** 
- **Value:** 0.075
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 405
- **Group ID:** OG001
- **Value:** 403
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.126
- **Upper Limit:** 
- **Value:** 0.088
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.232
- **Upper Limit:** 
- **Value:** 0.086
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 265
- **Group ID:** OG001
- **Value:** 281
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.119
- **Upper Limit:** 
- **Value:** 0.078
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.299
- **Upper Limit:** 
- **Value:** 0.115
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 185
- **Group ID:** OG001
- **Value:** 195
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.231
- **Upper Limit:** 
- **Value:** 0.121
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.163
- **Upper Limit:** 
- **Value:** 0.109
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 247
- **Group ID:** OG001
- **Value:** 264
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.171
- **Upper Limit:** 
- **Value:** 0.192
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.267
- **Upper Limit:** 
- **Value:** 0.205
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 257
- **Group ID:** OG001
- **Value:** 251
**Units:** Participants
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.5
- **Upper Limit:** 
- **Value:** -0.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.6
- **Upper Limit:** 
- **Value:** -0.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.8
- **Upper Limit:** 
- **Value:** -0.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.8
- **Upper Limit:** 
- **Value:** -0.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.9
- **Upper Limit:** 
- **Value:** -1.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.3
- **Upper Limit:** 
- **Value:** -0.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.2
- **Upper Limit:** 
- **Value:** -1.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.5
- **Upper Limit:** 
- **Value:** -1.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.3
- **Upper Limit:** 
- **Value:** -2.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.9
- **Upper Limit:** 
- **Value:** -1.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.8
- **Upper Limit:** 
- **Value:** -2.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.6
- **Upper Limit:** 
- **Value:** -1.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.3
- **Upper Limit:** 
- **Value:** -2.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.0
- **Upper Limit:** 
- **Value:** -1.4
**Title:** 
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 36.5
- **Spread:** 
- **Upper Limit:** 45.3
- **Value:** 40.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 42.4
- **Spread:** 
- **Upper Limit:** 51.2
- **Value:** 46.8
**Title:** 
#### Outcome Measure 18
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 12.9
- **Spread:** 
- **Upper Limit:** 19.5
- **Value:** 16.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 17.6
- **Spread:** 
- **Upper Limit:** 24.8
- **Value:** 21.0
**Title:** 
#### Outcome Measure 19
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5
- **Spread:** 
- **Upper Limit:** 15
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5
- **Spread:** 
- **Upper Limit:** 20
- **Value:** 8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 515
- **Group ID:** OG001
- **Value:** 518
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5
- **Spread:** 
- **Upper Limit:** 13
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5
- **Spread:** 
- **Upper Limit:** 15
- **Value:** 8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 491
- **Group ID:** OG001
- **Value:** 481
**Units:** Participants
#### Outcome Measure 20
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3
- **Spread:** 
- **Upper Limit:** 15
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 11
- **Value:** 4.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 70
- **Group ID:** OG001
- **Value:** 82
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3
- **Spread:** 
- **Upper Limit:** 10
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 7
- **Value:** 4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 65
- **Group ID:** OG001
- **Value:** 72
**Units:** Participants
#### Outcome Measure 21
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 6
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 6
- **Value:** 3
**Title:** 
#### Outcome Measure 22
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 8
- **Spread:** 
- **Upper Limit:** 28
- **Value:** 16
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 12
- **Spread:** 
- **Upper Limit:** 28
- **Value:** 27
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 46
- **Group ID:** OG001
- **Value:** 70
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6
- **Spread:** 
- **Upper Limit:** 22
- **Value:** 13
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 10
- **Spread:** 
- **Upper Limit:** 27
- **Value:** 20
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 39
- **Group ID:** OG001
- **Value:** 52
**Units:** Participants
#### Outcome Measure 23
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4
- **Spread:** 
- **Upper Limit:** 27
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4
- **Spread:** 
- **Upper Limit:** 28
- **Value:** 12
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 445
- **Group ID:** OG001
- **Value:** 446
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4
- **Spread:** 
- **Upper Limit:** 24
- **Value:** 9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4
- **Spread:** 
- **Upper Limit:** 28
- **Value:** 10
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 421
- **Group ID:** OG001
- **Value:** 409
**Units:** Participants
#### Outcome Measure 24
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 50
- **Spread:** 
- **Upper Limit:** 59
- **Value:** 55
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 47
- **Spread:** 
- **Upper Limit:** 55
- **Value:** 51
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 2
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 62
- **Spread:** 
- **Upper Limit:** 70
- **Value:** 66
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 55
- **Spread:** 
- **Upper Limit:** 64
- **Value:** 59
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 3
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 3
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 13
- **Spread:** 
- **Upper Limit:** 20
- **Value:** 16
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 14
- **Spread:** 
- **Upper Limit:** 21
- **Value:** 18
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 20
- **Spread:** 
- **Upper Limit:** 27
- **Value:** 23
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 23
- **Spread:** 
- **Upper Limit:** 31
- **Value:** 27
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 26
- **Spread:** 
- **Upper Limit:** 34
- **Value:** 30
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 30
- **Spread:** 
- **Upper Limit:** 38
- **Value:** 34
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 5
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3
- **Spread:** 
- **Upper Limit:** 6
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 6
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3
- **Spread:** 
- **Upper Limit:** 7
- **Value:** 5
**Title:** 
#### Outcome Measure 25
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 8
- **Spread:** 
- **Upper Limit:** 13
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 12
- **Spread:** 
- **Upper Limit:** 19
- **Value:** 15
**Title:** 
#### Outcome Measure 26
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 15
- **Spread:** 
- **Upper Limit:** 34
- **Value:** 23
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 30
- **Spread:** 
- **Upper Limit:** 52
- **Value:** 40
**Title:** 
#### Outcome Measure 27
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.5
- **Upper Limit:** 
- **Value:** 0.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.6
- **Upper Limit:** 
- **Value:** 0.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.7
- **Upper Limit:** 
- **Value:** 0.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.7
- **Upper Limit:** 
- **Value:** 0.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.9
- **Upper Limit:** 
- **Value:** -0.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.9
- **Upper Limit:** 
- **Value:** -0.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.0
- **Upper Limit:** 
- **Value:** -0.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.0
- **Upper Limit:** 
- **Value:** -0.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.9
- **Upper Limit:** 
- **Value:** -2.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.0
- **Upper Limit:** 
- **Value:** -1.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.9
- **Upper Limit:** 
- **Value:** -2.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.1
- **Upper Limit:** 
- **Value:** -2.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.9
- **Upper Limit:** 
- **Value:** -2.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.1
- **Upper Limit:** 
- **Value:** -2.5
**Title:** 
#### Outcome Measure 28
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 5
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 7
- **Spread:** 
- **Upper Limit:** 12
- **Value:** 9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 13
- **Spread:** 
- **Upper Limit:** 19
- **Value:** 16
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3
- **Spread:** 
- **Upper Limit:** 6
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 6
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6
- **Spread:** 
- **Upper Limit:** 11
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7
- **Spread:** 
- **Upper Limit:** 13
- **Value:** 10
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4
- **Spread:** 
- **Upper Limit:** 8
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 5
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 3
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 2
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 30
- **Spread:** 
- **Upper Limit:** 39
- **Value:** 34
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 28
- **Spread:** 
- **Upper Limit:** 36
- **Value:** 31
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 30
- **Spread:** 
- **Upper Limit:** 39
- **Value:** 34
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 28
- **Spread:** 
- **Upper Limit:** 36
- **Value:** 32
**Title:** 
#### Outcome Measure 29
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 8
- **Spread:** 
- **Upper Limit:** 13
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 9
- **Spread:** 
- **Upper Limit:** 14
- **Value:** 11
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 17
- **Spread:** 
- **Upper Limit:** 24
- **Value:** 20
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 18
- **Spread:** 
- **Upper Limit:** 26
- **Value:** 22
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 52
- **Spread:** 
- **Upper Limit:** 60
- **Value:** 56
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 49
- **Spread:** 
- **Upper Limit:** 58
- **Value:** 53
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 11
- **Spread:** 
- **Upper Limit:** 17
- **Value:** 14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 11
- **Spread:** 
- **Upper Limit:** 17
- **Value:** 14
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
**Title:** 
#### Outcome Measure 30
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 12
- **Spread:** 
- **Upper Limit:** 18
- **Value:** 15
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 13
- **Spread:** 
- **Upper Limit:** 20
- **Value:** 16
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 18
- **Spread:** 
- **Upper Limit:** 25
- **Value:** 22
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 18
- **Spread:** 
- **Upper Limit:** 25
- **Value:** 22
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 41
- **Spread:** 
- **Upper Limit:** 50
- **Value:** 45
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 40
- **Spread:** 
- **Upper Limit:** 49
- **Value:** 44
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 13
- **Spread:** 
- **Upper Limit:** 20
- **Value:** 16
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 12
- **Spread:** 
- **Upper Limit:** 18
- **Value:** 14
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 2
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 3
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 2
**Title:** 
#### Outcome Measure 31
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 2
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 12
- **Spread:** 
- **Upper Limit:** 19
- **Value:** 15
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 15
- **Spread:** 
- **Upper Limit:** 21
- **Value:** 18
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 14
- **Spread:** 
- **Upper Limit:** 20
- **Value:** 17
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 15
- **Spread:** 
- **Upper Limit:** 22
- **Value:** 18
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 31
- **Spread:** 
- **Upper Limit:** 39
- **Value:** 35
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 29
- **Spread:** 
- **Upper Limit:** 37
- **Value:** 33
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 16
- **Spread:** 
- **Upper Limit:** 22
- **Value:** 19
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 12
- **Spread:** 
- **Upper Limit:** 18
- **Value:** 15
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 2
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 2
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 8
- **Spread:** 
- **Upper Limit:** 13
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 10
- **Spread:** 
- **Upper Limit:** 16
- **Value:** 13
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 5
- **Value:** 3
**Title:** 
#### Outcome Measure 32
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 2
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 2
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 11
- **Spread:** 
- **Upper Limit:** 17
- **Value:** 13
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 15
- **Spread:** 
- **Upper Limit:** 22
- **Value:** 18
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 8
- **Spread:** 
- **Upper Limit:** 14
- **Value:** 11
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 9
- **Spread:** 
- **Upper Limit:** 15
- **Value:** 12
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 15
- **Spread:** 
- **Upper Limit:** 22
- **Value:** 18
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 15
- **Spread:** 
- **Upper Limit:** 22
- **Value:** 18
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 10
- **Spread:** 
- **Upper Limit:** 16
- **Value:** 12
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7
- **Spread:** 
- **Upper Limit:** 13
- **Value:** 10
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 2
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 2
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 35
- **Spread:** 
- **Upper Limit:** 44
- **Value:** 40
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 32
- **Spread:** 
- **Upper Limit:** 41
- **Value:** 36
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 5
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3
- **Spread:** 
- **Upper Limit:** 6
- **Value:** 4
**Title:** 
#### Outcome Measure 33
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 2
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 9
- **Spread:** 
- **Upper Limit:** 14
- **Value:** 11
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 13
- **Spread:** 
- **Upper Limit:** 20
- **Value:** 16
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5
- **Spread:** 
- **Upper Limit:** 9
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5
- **Spread:** 
- **Upper Limit:** 9
- **Value:** 7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 10
- **Spread:** 
- **Upper Limit:** 15
- **Value:** 12
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 8
- **Spread:** 
- **Upper Limit:** 13
- **Value:** 10
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6
- **Spread:** 
- **Upper Limit:** 11
- **Value:** 9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5
- **Spread:** 
- **Upper Limit:** 9
- **Value:** 7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 2
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 2
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 2
- **Value:** 0.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 2
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 52
- **Spread:** 
- **Upper Limit:** 60
- **Value:** 56
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 48
- **Spread:** 
- **Upper Limit:** 56
- **Value:** 52
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 5
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3
- **Spread:** 
- **Upper Limit:** 6
- **Value:** 4
**Title:** 
#### Outcome Measure 34
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3
- **Spread:** 
- **Upper Limit:** 6
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5
- **Spread:** 
- **Upper Limit:** 9
- **Value:** 6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4
- **Spread:** 
- **Upper Limit:** 8
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7
- **Spread:** 
- **Upper Limit:** 12
- **Value:** 9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 5
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 3
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 5
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3
- **Spread:** 
- **Upper Limit:** 7
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 3
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 21
- **Spread:** 
- **Upper Limit:** 28
- **Value:** 24
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 21
- **Spread:** 
- **Upper Limit:** 29
- **Value:** 25
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 40
- **Spread:** 
- **Upper Limit:** 49
- **Value:** 44
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 33
- **Spread:** 
- **Upper Limit:** 42
- **Value:** 37
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 6
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 5
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6
- **Spread:** 
- **Upper Limit:** 11
- **Value:** 9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 8
- **Spread:** 
- **Upper Limit:** 13
- **Value:** 10
**Title:** 
#### Outcome Measure 35
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3
- **Spread:** 
- **Upper Limit:** 7
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5
- **Spread:** 
- **Upper Limit:** 10
- **Value:** 7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 5
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5
- **Spread:** 
- **Upper Limit:** 9
- **Value:** 7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 3
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 3
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 5
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 5
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 2
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 2
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 20
- **Spread:** 
- **Upper Limit:** 27
- **Value:** 23
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 20
- **Spread:** 
- **Upper Limit:** 27
- **Value:** 23
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 44
- **Spread:** 
- **Upper Limit:** 53
- **Value:** 49
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 39
- **Spread:** 
- **Upper Limit:** 47
- **Value:** 43
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 3
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 9
- **Spread:** 
- **Upper Limit:** 15
- **Value:** 12
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 10
- **Spread:** 
- **Upper Limit:** 16
- **Value:** 13
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 1
- **Value:** 0.2
**Title:** 
#### Outcome Measure 36
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.01
- **Spread:** 
- **Upper Limit:** 0.03
- **Value:** 0.02
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.02
- **Spread:** 
- **Upper Limit:** 0.05
- **Value:** 0.03
**Title:** 
#### Outcome Measure 37
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.03
- **Spread:** 
- **Upper Limit:** 0.08
- **Value:** 0.05
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.06
- **Spread:** 
- **Upper Limit:** 0.11
- **Value:** 0.08
**Title:** 
#### Outcome Measure 38
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5.0
- **Spread:** 
- **Upper Limit:** 7.0
- **Value:** 6.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7.0
- **Spread:** 
- **Upper Limit:** 9.0
- **Value:** 8.0
**Title:** 
#### Outcome Measure 39
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 12.0
- **Spread:** 
- **Upper Limit:** 13.0
- **Value:** 12.0
- **Comment:** Due to a large number of subjects improving 13 days post randomization there is little variability at the 50th percentile and the methodology described by Klein and Moeschberger (1997) is unable to compute a confidence interval
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 13.0
**Title:** 
#### Outcome Measure 40
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6.0
- **Spread:** 
- **Upper Limit:** 7.0
- **Value:** 6.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.0
- **Spread:** 
- **Upper Limit:** 9.0
- **Value:** 7.0
**Title:** 
#### Outcome Measure 41
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 169.442
- **Upper Limit:** 
- **Value:** -23.035
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 102.661
- **Upper Limit:** 
- **Value:** -18.671
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 446
- **Group ID:** OG001
- **Value:** 455
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 110.364
- **Upper Limit:** 
- **Value:** -58.935
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 150.076
- **Upper Limit:** 
- **Value:** -30.908
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 368
- **Group ID:** OG001
- **Value:** 367
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 104.943
- **Upper Limit:** 
- **Value:** -78.411
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 125.254
- **Upper Limit:** 
- **Value:** -62.038
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 241
- **Group ID:** OG001
- **Value:** 250
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 124.751
- **Upper Limit:** 
- **Value:** -103.789
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 159.184
- **Upper Limit:** 
- **Value:** -88.881
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 159
- **Group ID:** OG001
- **Value:** 181
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 110.502
- **Upper Limit:** 
- **Value:** -122.339
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 155.762
- **Upper Limit:** 
- **Value:** -112.588
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 221
- **Group ID:** OG001
- **Value:** 240
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 115.243
- **Upper Limit:** 
- **Value:** -131.333
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 268.733
- **Upper Limit:** 
- **Value:** -122.342
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 217
- **Group ID:** OG001
- **Value:** 219
**Units:** Participants
#### Outcome Measure 42
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.062
- **Upper Limit:** 
- **Value:** -0.374
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.663
- **Upper Limit:** 
- **Value:** 0.384
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 436
- **Group ID:** OG001
- **Value:** 432
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 10.968
- **Upper Limit:** 
- **Value:** 0.053
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.978
- **Upper Limit:** 
- **Value:** -0.149
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 352
- **Group ID:** OG001
- **Value:** 347
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9.994
- **Upper Limit:** 
- **Value:** -0.271
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.387
- **Upper Limit:** 
- **Value:** 0.351
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 227
- **Group ID:** OG001
- **Value:** 230
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 12.779
- **Upper Limit:** 
- **Value:** 0.622
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.283
- **Upper Limit:** 
- **Value:** 0.309
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 153
- **Group ID:** OG001
- **Value:** 160
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 11.352
- **Upper Limit:** 
- **Value:** -0.988
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.579
- **Upper Limit:** 
- **Value:** -0.422
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 215
- **Group ID:** OG001
- **Value:** 230
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 27.229
- **Upper Limit:** 
- **Value:** 0.774
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 10.386
- **Upper Limit:** 
- **Value:** -0.219
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 223
- **Group ID:** OG001
- **Value:** 206
**Units:** Participants
#### Outcome Measure 43
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 7.0
- **Spread:** 
- **Upper Limit:** 13.0
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 9.0
- **Spread:** 
- **Upper Limit:** 13.0
- **Value:** 10.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 49
- **Group ID:** OG001
- **Value:** 52
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5.0
- **Spread:** 
- **Upper Limit:** 8.0
- **Value:** 7.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.0
- **Spread:** 
- **Upper Limit:** 8.0
- **Value:** 6.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 77
- **Group ID:** OG001
- **Value:** 79
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5.0
- **Spread:** 
- **Upper Limit:** 8.0
- **Value:** 7.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.0
- **Spread:** 
- **Upper Limit:** 9.0
- **Value:** 7.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 251
- **Group ID:** OG001
- **Value:** 245
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6.0
- **Spread:** 
- **Upper Limit:** 8.0
- **Value:** 7.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.0
- **Spread:** 
- **Upper Limit:** 11.0
- **Value:** 8.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 138
- **Group ID:** OG001
- **Value:** 142
**Units:** Participants
#### Outcome Measure 44
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6.0
- **Spread:** 
- **Upper Limit:** 8.0
- **Value:** 7.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7.0
- **Spread:** 
- **Upper Limit:** 10.0
- **Value:** 9.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 246
- **Group ID:** OG001
- **Value:** 240
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6.0
- **Spread:** 
- **Upper Limit:** 8.0
- **Value:** 7.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.0
- **Spread:** 
- **Upper Limit:** 9.0
- **Value:** 7.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 263
- **Group ID:** OG001
- **Value:** 268
**Units:** Participants
#### Outcome Measure 45
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6.0
- **Spread:** 
- **Upper Limit:** 8.0
- **Value:** 7.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7.0
- **Spread:** 
- **Upper Limit:** 11.0
- **Value:** 9.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 319
- **Group ID:** OG001
- **Value:** 333
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6.0
- **Spread:** 
- **Upper Limit:** 8.0
- **Value:** 7.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.0
- **Spread:** 
- **Upper Limit:** 7.0
- **Value:** 7.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 196
- **Group ID:** OG001
- **Value:** 185
**Units:** Participants
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The intent-to-treat (ITT) population includes all participants who were randomized
**Reporting Status:** POSTED
**Time Frame:** Day 1 through Day 29
**Title:** Time to Recovery
**Type:** PRIMARY
**Unit of Measure:** Days
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 2
**Description:** Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
**Reporting Status:** POSTED
**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29
**Title:** Change From Baseline in Alanine Transaminase (ALT)
**Type:** SECONDARY
**Unit of Measure:** Units/Liter (U/L)
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 3
**Description:** Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
**Reporting Status:** POSTED
**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29
**Title:** Change From Baseline in Aspartate Transaminase (AST)
**Type:** SECONDARY
**Unit of Measure:** Units/Liter (U/L)
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 4
**Description:** Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
**Reporting Status:** POSTED
**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29
**Title:** Change From Baseline in Creatinine
**Type:** SECONDARY
**Unit of Measure:** milligrams/deciliter (mg/dL)
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 5
**Description:** Blood to evaluate serum glucose was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
**Reporting Status:** POSTED
**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29
**Title:** Change From Baseline in Glucose
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 6
**Description:** Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
**Reporting Status:** POSTED
**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29
**Title:** Change From Baseline in Hemoglobin
**Type:** SECONDARY
**Unit of Measure:** grams/deciliter (g/dL)
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 7
**Description:** Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
**Reporting Status:** POSTED
**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29
**Title:** Change From Baseline in Platelets
**Type:** SECONDARY
**Unit of Measure:** 10^9 cells/liter
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 8
**Description:** Blood to evaluate INR was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
**Reporting Status:** POSTED
**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29
**Title:** Change From Baseline in Prothrombin International Normalized Ratio (INR)
**Type:** SECONDARY
**Unit of Measure:** ratio
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 9
**Description:** Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
**Reporting Status:** POSTED
**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29
**Title:** Change From Baseline in Total Bilirubin
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 10
**Description:** Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
**Reporting Status:** POSTED
**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29
**Title:** Change From Baseline in White Blood Cell Count (WBC)
**Type:** SECONDARY
**Unit of Measure:** 10^9 cells/liter
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 11
**Description:** BBlood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
**Reporting Status:** POSTED
**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29
**Title:** Change From Baseline in Neutrophils
**Type:** SECONDARY
**Unit of Measure:** 10^9 cells/liter
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 12
**Description:** Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
**Reporting Status:** POSTED
**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29
**Title:** Change From Baseline in Lymphocytes
**Type:** SECONDARY
**Unit of Measure:** 10^9 cells/liter
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 13
**Description:** Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
**Reporting Status:** POSTED
**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29
**Title:** Change From Baseline in Monocytes
**Type:** SECONDARY
**Unit of Measure:** 10^9 cells/liter
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 14
**Description:** Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
**Reporting Status:** POSTED
**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29
**Title:** Change From Baseline in Basophils
**Type:** SECONDARY
**Unit of Measure:** 10^9 cells/liter
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 15
**Description:** Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
**Reporting Status:** POSTED
**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29
**Title:** Change From Baseline in Eosinophils
**Type:** SECONDARY
**Unit of Measure:** 10^9 cells/liter
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 16
**Description:** The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The intent-to-treat (ITT) population includes all participants who were randomized with data at baseline and at each timepoint. Missing values were imputed using Last Observation Carried Forward.
**Reporting Status:** POSTED
**Time Frame:** Days 1, 3, 5, 8, 11, 15, 22, and 29
**Title:** Change in National Early Warning Score (NEWS) From Baseline
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 17
**Description:** Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The safety population includes all participants with available data post baseline, analyzed as treated.
**Reporting Status:** POSTED
**Time Frame:** Day 1 through Day 29
**Title:** Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 18
**Description:** An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The safety population includes all participants with available data post baseline, analyzed as treated.
**Reporting Status:** POSTED
**Time Frame:** Day 1 through Day 29
**Title:** Percentage of Participants Reporting Serious Adverse Events (SAEs)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 19
**Description:** Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** The intent-to-treat (ITT) population includes all participants who were randomized
**Reporting Status:** POSTED
**Time Frame:** Day 1 through Day 29
**Title:** Duration of Hospitalization
**Type:** SECONDARY
**Unit of Measure:** Days
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 20
**Description:** Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** The analysis population is restricted to randomized participants who were not on non-invasive ventilation or high-flow oxygen at baseline but who subsequently required non-invasive or high-flow oxygen.
**Reporting Status:** POSTED
**Time Frame:** Day 1 through Day 29
**Title:** Duration of New Non-invasive Ventilation or High Flow Oxygen Use
**Type:** SECONDARY
**Unit of Measure:** Days
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 21
**Description:** Duration of new oxygen use was measured in days among participants who were not on oxygen at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** The analysis population is restricted to randomized participants who were not on oxygen at baseline but who subsequently required oxygen.
**Reporting Status:** POSTED
**Time Frame:** Day 1 through Day 29
**Title:** Duration of New Oxygen Use
**Type:** SECONDARY
**Unit of Measure:** Days
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 22
**Description:** Duration of new ventilator or ECMO use was measured in days among participants who were not on a ventilator or ECMO at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** The analysis population is restricted to randomized participants not on a ventilator or ECMO at baseline but who subsequently required a ventilator or ECMO.
**Reporting Status:** POSTED
**Time Frame:** Day 1 through Day 29
**Title:** Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use
**Type:** SECONDARY
**Unit of Measure:** Days
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 23
**Description:** Duration of oxygen use was measured in days among participants who were on oxygen in based, calculated in two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** The analysis population is restricted to randomized participants who were on oxygen at baseline.
**Reporting Status:** POSTED
**Time Frame:** Day 1 through Day 29
**Title:** Duration of Oxygen Use
**Type:** SECONDARY
**Unit of Measure:** Days
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 24
**Description:** Participants may have been discontinued from investigational therapeutics due to discharge or death. The halting or slowing of the infusion for any reason was collected, as was missed doses in the series of 10 doses of Remdesivir, or in the 14 doses of Baricitinib/placebo.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The intent-to-treat (ITT) population includes all participants who were randomized
**Reporting Status:** POSTED
**Time Frame:** Day 1 through Day 14
**Title:** Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 25
**Description:** The percentage of participants requiring new ventilator or ECMO use was determined as the percentage not on a ventilator or ECMO at baseline
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The analysis population is restricted to randomized participants not on a ventilator or ECMO at baseline.
**Reporting Status:** POSTED
**Time Frame:** Day 1 through Day 29
**Title:** Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 26
**Description:** The percentage of participants requiring new oxygen use was determined as the percentage of participants not requiring oxygen at baseline
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The analysis population is restricted to randomized participants not requiring oxygen at baseline.
**Reporting Status:** POSTED
**Time Frame:** Day 1 through Day 29
**Title:** Percentage of Participants Requiring New Oxygen Use
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 27
**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. A positive change indicates a worsening and a negative change is an improvement.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The intent-to-treat (ITT) population includes all participants who were randomized reporting a clinical score. Missing values were imputed using Last Observation Carried Forward.
**Reporting Status:** POSTED
**Time Frame:** Day 1, 3, 5, 8, 11, 15, 22, and 29
**Title:** Mean Change in the Ordinal Scale
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 28
**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Data was imputed using last observation carried forward or worst possible score based on hospitalization status (2 if not hospitalized, 7 if hospitalized) when there was a change in hospitalization status since last score. Deaths were imputed as an 8.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The intent-to-treat (ITT) population includes all participants who were randomized.
**Reporting Status:** POSTED
**Time Frame:** Day 15
**Title:** Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 29
**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The intent-to-treat (ITT) population includes all participants who were randomized
**Reporting Status:** POSTED
**Time Frame:** Day 1
**Title:** Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 30
**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The intent-to-treat (ITT) population includes all participants who were randomized
**Reporting Status:** POSTED
**Time Frame:** Day 3
**Title:** Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 31
**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The intent-to-treat (ITT) population includes all participants who were randomized
**Reporting Status:** POSTED
**Time Frame:** Day 5
**Title:** Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 32
**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The intent-to-treat (ITT) population includes all participants who were randomized
**Reporting Status:** POSTED
**Time Frame:** Day 8
**Title:** Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 33
**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The intent-to-treat (ITT) population includes all participants who were randomized
**Reporting Status:** POSTED
**Time Frame:** Day 11
**Title:** Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 34
**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The intent-to-treat (ITT) population includes all participants who were randomized
**Reporting Status:** POSTED
**Time Frame:** Day 22
**Title:** Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 35
**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The intent-to-treat (ITT) population includes all participants who were randomized
**Reporting Status:** POSTED
**Time Frame:** Day 29
**Title:** Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 36
**Description:** The mortality rate was determined as the proportion of participants who died by study Day 15. The proportions reported are Kaplan-Meier estimates.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The ITT population consists of all participants as randomized.
**Reporting Status:** POSTED
**Time Frame:** Day 1 through Day 15
**Title:** 14-day Participant Mortality
**Type:** SECONDARY
**Unit of Measure:** proportion of participants
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 37
**Description:** The mortality rate was determined as the proportion of participants who died by study Day 29. The proportions reported are Kaplan-Meier estimates.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The ITT population includes all participants as randomized.
**Reporting Status:** POSTED
**Time Frame:** Day 1 through Day 29
**Title:** 28-day Participant Mortality
**Type:** SECONDARY
**Unit of Measure:** proportion of participants
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 38
**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Time to improvement by at least one category was determined for each participant
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The ITT population includes all participants as randomized
**Reporting Status:** POSTED
**Time Frame:** Day 1 through Day 29
**Title:** Time to an Improvement of One Category Using an Ordinal Scale
**Type:** SECONDARY
**Unit of Measure:** Days
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 39
**Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Time to improvement by at least two categories was determined for each participant
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The ITT population includes all participants as randomized
**Reporting Status:** POSTED
**Time Frame:** Day 1 through Day 29
**Title:** Time to an Improvement of Two Categories Using an Ordinal Scale
**Type:** SECONDARY
**Unit of Measure:** Days
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 40
**Description:** The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome. The time to discharge or a NEWS of less than or equal to 2 was determined for each participant.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The ITT population includes participants as randomized, and restricted to those with a baseline NEWS score of 2 or greater.
**Reporting Status:** POSTED
**Time Frame:** Day 1 through Day 29
**Title:** Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First
**Type:** SECONDARY
**Unit of Measure:** Days
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 41
**Description:** Blood to evaluate CRP was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
**Reporting Status:** POSTED
**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29
**Title:** Change From Baseline in C-reactive Protein (CRP)
**Type:** SECONDARY
**Unit of Measure:** mg/L
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 42
**Description:** Blood to evaluate d-dimer concentration was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
**Reporting Status:** POSTED
**Time Frame:** Days 1, 3, 5, 8, 11, 15 and 29
**Title:** Change From Baseline in D-dimer Concentration
**Type:** SECONDARY
**Unit of Measure:** mg/L
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 43
**Description:** Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The intent-to-treat (ITT) population includes all participants who were randomized
**Reporting Status:** POSTED
**Time Frame:** Day 1 through Day 29
**Title:** Time to Recovery by Race
**Type:** PRIMARY
**Unit of Measure:** Days
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 44
**Description:** Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The intent-to-treat (ITT) population includes all participants who were randomized and for whom ethnicity was reported
**Reporting Status:** POSTED
**Time Frame:** Day 1 through Day 29
**Title:** Time to Recovery by Ethnicity
**Type:** PRIMARY
**Unit of Measure:** Days
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
#### Outcome Measure 45
**Description:** Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The intent-to-treat (ITT) population includes all participants who were randomized
**Reporting Status:** POSTED
**Time Frame:** Day 1 through Day 29
**Title:** Time to Recovery by Sex
**Type:** PRIMARY
**Unit of Measure:** Days
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG000
**Title:** Remdesivir Plus Baricitinib
##### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
**ID:** OG001
**Title:** Remdesivir Plus Placebo
### Participant Flow Module
#### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.

Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.

Baricitinib: Baricitinib is a Janus kinase (JAK) inhibitor with the chemical name \[1-(ethylsulfonyl)-3-(4-(7Hpyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)azetidin-3-yl\]acetonitrile Each tablet contains 2 mg of baricitinib and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
**ID:** FG000
**Title:** Remdesivir Plus Baricitinib
#### Group
**Description:** 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.

Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.

Placebo: The matching Baricitinib placebo contains lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The coating for the placebo tablet is identical to that of the corresponding active tablet
**ID:** FG001
**Title:** Remdesivir Plus Placebo
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 23
###### Reason
**Group ID:** FG001
**Number of Subjects:** 36
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 40
###### Reason
**Group ID:** FG001
**Number of Subjects:** 41
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 8
###### Reason
**Group ID:** FG001
**Number of Subjects:** 16
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Became ineligible after enrollment
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Enrolled but treatment not administered
###### Reason
**Group ID:** FG000
**Number of Subjects:** 7
###### Reason
**Group ID:** FG001
**Number of Subjects:** 9
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Scheduling error
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Transferred to another hospital
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 515
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 518
##### Milestone
**Type:** Treated
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 507
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 509
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 431
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 408
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 84
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 110
**Recruitment Details:** Participants were recruited at the participating sites from those admitted with symptoms of COVID-19 confirmed by PCR. Enrollment occurred between 08May2020 and 01Jul2020.
**Has Results:** True