## Protocol Section
### Identification Module
**NCT ID:** NCT04497779

**Brief Title:** Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma

**Official Title:** Evaluation of Coronavirus Disease 19 (COVID-19) Convalescent Plasma

#### Organization Study ID Info
**ID:** 20204
#### Organization
**Class:** OTHER
**Full Name:** City of Hope Medical Center
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2020-04000
**Type:** REGISTRY
**Domain:** City of Hope Medical Center
**ID:** 20204
**Type:** OTHER
**ID:** P30CA033572
**Link:** https://reporter.nih.gov/quickSearch/P30CA033572
**Type:** NIH
**Domain:** Translational Genomics Research Institute (TGen)
**ID:** TGen
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-06-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-16

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-06-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-07-13

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2020-08-04
**Type:** ACTUAL
**Study First Submit Date:** 2020-06-29
**Study First Submit QC Date:** 2020-07-31
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

**Class:** OTHER

**Name:** California Institute for Regenerative Medicine (CIRM)

#### Lead Sponsor

**Class:** OTHER

**Name:** City of Hope Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Plasma from patients who have recovered from coronavirus disease 2019 (COVID-19) is referred to as COVID-19 convalescent plasma (CCP), and may contain antibodies against SARS-CoV-2, the virus responsible for COVID-19. CCP infusion is being evaluated as a therapeutic or prophylactic approach in COVID-19 patients. The goal of this study is to help develop a bank of convalescent plasma in California, especially in medically underserved communities particularly affected by the disease. In parallel, CCP administered to COVID-19 patients will be collected and analyzed to determine whether the antibody profile correlates with clinical outcome. The purpose of this non-therapeutic study is to learn more about the CCP antibody profile and the effect it may have in treating COVID-19 infection.

**Detailed Description:** PRIMARY OBJECTIVES:

I. Establish a testing service for screening prospective donors of coronavirus disease 2019 (COVID-19) convalescent plasma (CCP).

II. Characterize the titer and neutralizing properties of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies in CCP.

III. Correlate the SARS-CoV-2 antibody characteristics in CCP with the outcome in severely ill COVID-19 patients treated with CCP.

EXPLORATORY OBJECTIVES:

I. Facilitate the recruitment of CCP donors in medically underserved areas.

II. Develop high-throughput methods for detection/characterization of SARS-CoV-2 neutralizing and non-neutralizing antibodies.

III. Develop a bank of convalescent plasma that would be available for future studies relating to the content of CCP.

IV. Study the impact of antibody levels, donor characteristics and patient characteristics on outcome in COVID-19 patients treated with CCP.

V. Procure blood samples from COVID-19 convalescent volunteers for future COVID-19-related studies.

OUTLINE:

PROSPECTIVE CCP DONORS: Participants undergo collection of blood and/or nasopharyngeal swabs at the time of screening. Participants' medical records are reviewed.

CONVALESCENT BLOOD DONORS WHO CHOOSE NOT TO DONATE CCP: Participants undergo collection of blood sample at the time of screening. Participants' medical records are reviewed.

CCP RECIPIENTS: Patients undergo collection collection of blood samples at baseline, between CCP unit infusions, 24 hours after last CCP infusion, and between 14-28 after last CCP infusion. Patients' medical records are reviewed.

### Conditions Module

**Conditions:**

- Asymptomatic COVID-19 Infection Laboratory-Confirmed

- Symptomatic COVID-19 Infection Laboratory-Confirmed

### Design Module

#### Bio Spec

**Description:** Nasopharyngeal swab, blood samples

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 95

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** PROSPECTIVE CCP DONORS: Participants undergo collection of blood and/or nasopharyngeal swabs at the time of screening. Participants' medical records are reviewed.

CONVALESCENT BLOOD DONORS WHO CHOOSE NOT TO DONATE CCP: Participants undergo collection of blood sample at the time of screening. Participants' medical records are reviewed.

CCP RECIPIENTS: Patients undergo collection of blood samples at baseline, 12-24 hours after each CCP infusion, and 7 days after last CCP infusion. Patients' medical records are reviewed.

**Intervention Names:**

- Procedure: Biospecimen Collection

- Other: Diagnostic Laboratory Biomarker Analysis

- Other: Electronic Health Record Review

- Other: Questionnaire Administration

**Label:** Screening (biospecimen collection, medical record review, CCP)

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Screening (biospecimen collection, medical record review, CCP)

**Description:** Undergo collection of blood and/or nasopharyngeal swabs

**Name:** Biospecimen Collection

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Screening (biospecimen collection, medical record review, CCP)

**Description:** Correlative studies

**Name:** Diagnostic Laboratory Biomarker Analysis

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Screening (biospecimen collection, medical record review, CCP)

**Description:** Donors and recipients have their medical records reviewed.

**Name:** Electronic Health Record Review

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Screening (biospecimen collection, medical record review, CCP)

**Description:** Ancillary studies

**Name:** Questionnaire Administration

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** Patient can stay at the hospital for up to 28 days post-CCP infusion

**Measure:** Duration of hospitalization (days)

**Time Frame:** Up to 28 days post-CCP infusion

**Description:** Will be assessed on a 7-point ordinal scale.

**Measure:** Time to clinical improvement (days)

**Time Frame:** Up to 28 days post-CCP infusion

#### Primary Outcomes

**Description:** Will be assayed for severe acute respiratory syndrome (SARS-CoV-2) immunoassay, coronavirus (CoV) PepSeq assay, and SARS-CoV-2 lenti-based neutralizing antibody titer.

**Measure:** Convalescent plasma (CCP) units infused in coronavirus disease-2019 (COVID-19) patients

**Time Frame:** Up to 12 months after enrollment

**Description:** Will naturally be compared to reported data from the other studies. Analysis will focus on demonstrating that the antibody content of donor plasma increases the odds of surviving past day 28. Will also develop a nomogram for the probability of success (alive at day 28), accounting for patient, donor material and donor antibody characteristics measurable covariates.

**Measure:** All-cause mortality

**Time Frame:** At day 28 post-CCP infusion

**Description:** Will be examined to see how this relates to the duration of hospitalization.

**Measure:** Donor antibody levels

**Time Frame:** Up to 28 days post-CCP infusion

#### Secondary Outcomes

**Description:** Will be assessed on a 7-point ordinal scale, as recommended by the WHO patient outcome R\&D Blueprint Group.

**Measure:** Incidence of adverse events

**Time Frame:** Up to 28 days post-CCP infusion

**Description:** Will be assessed on a 7-point ordinal scale. The scale is as follows:

1. Death;
2. Hospitalized, on invasive mechanical ventilation or ECMO;
3. Hospitalized, on non-invasive ventilation or high flow oxygen devices;
4. Hospitalized, requiring low flow 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 (other than per protocol RDV administration);
7. Not hospitalized

**Measure:** CCP recipient outcomes

**Time Frame:** Up to 28 days post-CCP infusion

### Eligibility Module

**Eligibility Criteria:** For COVID-19 convalescent individuals:

* Age: ≥ 18 years
* Evidence of COVID-19 documented by a laboratory test either by: a diagnostic test (e.g., a NP swab) at the time of illness OR a positive serological test for SARS-CoV-2 antibodies after recovery, if prior diagnostic testing was not performed at the time COVID-19 was suspected.

Note: If volunteers can't provide evidence of COVID-19, but are otherwise eligible, then we will test them for SARS-CoV-2 antibodies to confirm eligibility.

* Be willing to complete a pre-screening questionnaire
* Be willing to donate blood samples
* Permit medical record review
* For prospective CCP donors only: weigh more than 110 pounds and be in general good health

For (COVID-19 convalescent plasma (CCP) recipients:

* Be enrolled in a clinical trial involving the infusion of CCP for the treatment of COVID-19.
* Be willing to provide blood samples
* Permit medical record review

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with diagnosis of laboratory-confirmed COVID-19 infection

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Duarte

**Country:** United States

**Facility:** City of Hope Medical Center

**State:** California

**Zip:** 91010

#### Overall Officials

**Official 1:**

**Affiliation:** City of Hope Medical Center

**Name:** John Zaia

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract 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

- ID: D000009784

- Term: Occupational 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

- Abbrev: BC24

- Name: Occupational Diseases

### Condition Browse Module - Browse Leaves

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: COVID-19

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M20490

- Name: Coronavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M10777

- Name: Laboratory Infection

- Relevance: HIGH

- As Found: Infection Laboratory-

- ID: M22700

- Name: Disease Attributes

- 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: 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

- ID: M12719

- Name: Occupational Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000086382

- Term: COVID-19

- ID: D000007757

- Term: Laboratory Infection

### Misc Info Module

- Version Holder: 2024-05-24
