Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Other: Diagnostic Laboratory Biomarker Analysis
* Other: Electronic Health Record Review
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Screening (biospecimen collection, medical record review, CCP)<br>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. | Procedure: Biospecimen Collection<br>* Undergo collection of blood and/or nasopharyngeal swabs<br>Other: Diagnostic Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Electronic Health Record Review<br>* Donors and recipients have their medical records reviewed.<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Convalescent plasma (CCP) units infused in coronavirus disease-2019 (COVID-19) patients | 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. | Up to 12 months after enrollment | 
| All-cause mortality | 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. | At day 28 post-CCP infusion | 
| Donor antibody levels | Will be examined to see how this relates to the duration of hospitalization. | Up to 28 days post-CCP infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Will be assessed on a 7-point ordinal scale, as recommended by the WHO patient outcome R&D Blueprint Group. | Up to 28 days post-CCP infusion | 
| CCP recipient outcomes | Will be assessed on a 7-point ordinal scale. The scale is as follows: Death; Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring low flow supplemental oxygen; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per protocol RDV administration); Not hospitalized | Up to 28 days post-CCP infusion |