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.
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.
Biological: Standard Donor Plasma
450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
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
Stony Brook University Hospital
Stony Brook, New York, United States
Elliott Bennett-Guerrero, MD, Principal Investigator
Stony Brook Hospital