Official Title
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
Brief Summary

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.

Enrolling by invitation
COVID

Biological: Convalescent Plasma
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.
Convalescent Donor Plasma

Biological: Standard Donor Plasma
450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
Standard Donor Plasma

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

Stony Brook University Hospital
Stony Brook, New York, 11794

Elliott Bennett-Guerrero, MD
Principal Investigator
Stony Brook Hospital

Stony Brook University
NCT Number