Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day 28.
This randomized, controlled, double-blinded phase 2 trial will assess the efficacy and safety
of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as
defined in the inclusion criteria). Adults 18 years of age and older with high risk exposure
as defined by CDC may participate. A total of 500 eligible subjects will be randomized in a
1:1 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2
non-immune plasma).
Biological: Anti- SARS-CoV-2 Plasma
SARS-CoV-2 convalescent plasma (1 unit; ~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320
Biological: SARS-CoV-2 non-immune Plasma
Normal human plasma collected prior to December 2019
Inclusion Criteria
1. Subjects must be 18 years of age or older
2. Close contact exposure (as defined by CDC guidelines) to person with COVID-19 within
96 hours of randomization (and 120 hours of receipt of plasma)
Exclusion Criteria
1. Receipt of any blood product in past 120 days.
2. Medical, psychiatric,cognitive illness or recreational drug/alcohol use that in the
opinion of the principal investigator, would affect subject safety and/or compliance.
3. Symptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of
breath) at time of screening.
4. Laboratory evidence of COVID-19 infection at time of screening.
5. History or known laboratory evidence of previous COVID-19 infection.
6. History of prior reactions to transfusion blood products.
7. Inability to complete therapy with the study product within 24 hours after
randomization.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Center for American Indian Health - Whiteriver Office
Whiteriver, Arizona, United States
University of California, San Diego
La Jolla, California, United States
University of California, Los Angeles
Los Angeles, California, United States
University of California, Irvine Health
Orange, California, United States
Western Connecticut Health Network, Danbury Hospital
Danbury, Connecticut, United States
Western Connecticut Health Netowrk, Norwalk Hospital
Norwalk, Connecticut, United States
MedStar Georgetown University Hospital
Washington, District of Columbia, United States
University of Miami
Coral Gables, Florida, United States
University of Miami Clinical Translational Research Site
Miami, Florida, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
The Johns Hopkins University
Baltimore, Maryland, United States
University of Massachusetts Worcester
Worcester, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Center for American Indian Health - Gallup Office
Gallup, New Mexico, United States
Center for American Indian Health - Shiprock Office
Shiprock, New Mexico, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, United States
University of Rochester
Rochester, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Lifespan/BrownUniversity (Rhode Island Hospital)
Providence, Rhode Island, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
The University of Utah
Salt Lake City, Utah, United States
Shmuel Shoham, MD, Principal Investigator
Johns Hopkins University