The overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration. This study will enroll adults presenting to the emergency department (ED) with mild, symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization.
Biological: Convalescent Plasma
SARS-CoV-2 convalescent plasma with neutralizing SARS-CoV2 antibodies titers of ≥1:160 administered via intravenous (IV) infusion.
Biological: Saline
Saline with multivitamin administered via intravenous (IV) infusion..
Inclusion Criteria:
- One or more symptoms of COVID-19 illness and laboratory-confirmed SARS-CoV-2 infection
- Has at least one study defined risk factor for severe COVID-19 illness
- Clinical team deems stable for outpatient management without supplemental oxygen
- CP available at the site at the time of enrollment
- Duration of symptoms ≤ 7 days at ED presentation
- Informed consent from subject
Exclusion Criteria:
- Age less than 18 years
- Prisoner or ward of the state
- Presumed unable to complete follow-up assessments
- Prior adverse reaction(s) from blood product transfusion
- Receipt of any blood product within the past 120 days
- Treating clinical team unwilling to administer 300 ml fluid
- Enrollment in another interventional trial for COVID-19 illness
Chandler Regional Medical Center
Chandler, Arizona, United States
Valleywise Health Medical Center
Phoenix, Arizona, United States
UCSD Health La Jolla
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
Stanford University
Stanford, California, United States
Harbor-UCLA Medical Center
Torrance, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
UF Health Shands Hospital
Gainesville, Florida, United States
Jackson Memorial Hospital
Miami, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois Hospital
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Maine Medical Center
Portland, Maine, United States
Tufts Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Newton-Wellesley Hospital
Newton, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of Michigan University Hospital
Ann Arbor, Michigan, United States
Detroit Receiving Hospital
Detroit, Michigan, United States
Harper University Hospital
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Sinai-Grace Hospital
Detroit, Michigan, United States
Spectrum Health Hospitals Butterworth Hospital
Grand Rapids, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
William Beaumont Hospital-Troy
Troy, Michigan, United States
HealthPartners Methodist Hospital
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Barnes Jewish Hospital
Saint Louis, Missouri, United States
Cooper University Hospital
Camden, New Jersey, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
University of New Mexico Hospital
Albuquerque, New Mexico, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Duke University Hospital
Durham, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
OSU Wexner Medical Center
Columbus, Ohio, United States
Mercy St. Vincent Medical Center
Toledo, Ohio, United States
Oregon Health & Science University Hospital
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Einstein Medical Center
Philadelphia, Pennsylvania, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
William P. Clements Jr. University Hospital
Dallas, Texas, United States
Ben Taub General Hospital
Houston, Texas, United States
Memorial Hermann Texas Medical Center
Houston, Texas, United States
University of Utah Healthcare
Salt Lake City, Utah, United States
Froedtert Hospital
Milwaukee, Wisconsin, United States