Convalescent Plasma vs. Standard Plasma for COVID-19

Stony Brook University

Status and phase

Terminated

Phase 2

Phase 1

Conditions

COVID

Treatments

Biological: Standard Donor Plasma

Biological: Convalescent Plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT04344535

SBU-COVID19-ConvalescentPlasma

Details and patient eligibility

About

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.

Enrollment

82 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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