To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding.
The purpose of this randomized, double-blind, controlled, phase 2 trial is to evaluate the
efficacy of treatment with HCIP in reducing hospitalization and death prior to
hospitalization among outpatient adults who have RNA detection test-confirmed COVID-19 AND
have developed any symptoms of COVID-19 including but not limited to fever, cough, or other
COVID associated symptoms like anosmia. Ambulatory/outpatient adults subjects 18 years of age
or older, regardless of risk factors for severe illness may participate. A total of
approximately 1344 eligible subjects stratified with a target goal (but not binding) of 50:50
in the <65 vs ≥ 65 age range will be randomized in a 1:1 ratio to receive either HCIP or
control plasma.
Biological: SARS-CoV-2 convalescent plasma
SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.
Other Name: Human coronavirus immune plasma (HCIP)
Biological: Plasma from a volunteer donor
Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.
Inclusion Criteria:
- ≥ 18 years of age
- Competent and capable to provide informed consent
- • Positive molecular test for presence of SARS-CoV-2 in fluid collected by saliva for
antigen, oropharyngeal or nasopharyngeal swab
- Experiencing any symptoms of COVID-19 including but not limited to fever(T> 100.5º F),
cough, or other COVID associated symptoms like anosmia
- ≤ 8 days since the first symptoms of COVID-19
- ≤ 8 days since first positive SARS-CoV-2 RNA test
- Able and willing to comply with protocol requirements listed in the informed consent
Exclusion Criteria:
- Hospitalized or expected to be hospitalized within 24 hours of enrollment
- Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion
of the principal investigator, would affect subject safety and/or compliance
- History of prior reactions to transfusion blood products
- Inability to complete therapy with the study product within 24 hours after enrollment
- Receiving any treatment drug for COVID-19 within 14 days prior to screening evaluation
(monoclonal antibodies, compassionate use or study trial related). Steroid treatment
at any time does not affect study eligibility
University of Alabama at Birmingham
Birmingham, Alabama, United States
Center for American Indian Health - Chinle Office
Chinle, Arizona, United States
Mayo Clinic, Phoenix
Phoenix, Arizona, United States
University of Arizona, Phoenix
Tucson, Arizona, United States
University of Arizona, Tuscon
Tucson, Arizona, United States
Center for American Indian Health - Whiteriver Office
Whiteriver, Arizona, 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 Network, Norwalk Hospital
Norwalk, Connecticut, 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
Tulane University
New Orleans, Louisiana, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
The Johns Hopkins University
Baltimore, Maryland, United States
MedStar Washington Hospital Center
Hyattsville, 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
David J Sullivan, MD, Principal Investigator
The Johns Hopkins University