Convalescent Plasma vs. Standard Plasma for COVID-19

Study Overview
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Brief Summary
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The purpose of this study is to find out if transfusion of blood plasma containing antibodies against COVID-19 (anti-SARS-CoV-2), which were donated from a patient who recovered from COVID-19 infection, is safe and can treat COVID-19 in hospitalized patients. Antibodies are blood proteins produced by the body in response to a virus and can remain in the person's bloodstream (plasma) for a long time after they recover. Transferring plasma from a person who recovered from COVID-19 may help neutralize the virus in sick patients' blood, and/or reduce the chances of the infection getting worse.

Official Title
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Convalescent Plasma to Reduce Complications Associated With COVID-19 Infection: A Randomized Trial Comparing the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma vs. Standard Plasma in Hospitalized Patients With COVID- 19 Infection

Conditions
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COVID

Intervention / Treatment
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* Biological: Convalescent Plasma
* Biological: Standard Donor Plasma


Participation Criteria
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Eligibility Criteria
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There are 2 groups of research subjects: plasma donor and recipients Volunteer plasma donors can donate Convalescent Plasma if they: have adequate antibody levels against COVID-19 per FDA Guidelines have had no symptoms of COVID-19 for at least 14 days meet routine plasma donation criteria Inclusion Criteria for Plasma Recipients: Adults 18 years of age or older Hospitalized with PCR+ COVID-19 infection If female must not be pregnant and/or breastfeeding. Exclusion Criteria for Plasma Recipients: Unable to randomize patient within 14 days of admission to Stony Brook Hospital (or any other hospital if a transfer to Stony Brook Hospital). In the treating physician's opinion, the patient cannot tolerate a 450-550 mL infusion of plasma over up to 8 hours (4 hours max per unit), even if prophylaxed with intravenous diuretic Contraindication to transfusion or history of prior reactions to blood transfusions

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Convalescent Donor Plasma<br> | Biological: Convalescent Plasma<br>* 450-550 mL of plasma containing anti-SARS-CoV-2 antibody titer ideally > 1:320, but meeting minimum titer per FDA Guidelines for convalescent plasma.<br>|
| Placebo Comparator: Standard Donor Plasma<br> | Biological: Standard Donor Plasma<br>* 450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 Day Ventilator Free Days | Number of days a patient is receiving mechanical invasive ventilation through 28 days post randomization. Patients who die during this time period are assigned 0 ventilator free days. | 28 days post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90 Day All-cause Mortality | All cause mortality from randomization until 90 days post randomization | 90 days |