Convalescent Plasma to Stem Coronavirus (CSSC-001)

Completed · Phase 2

Conditions studied: Coronavirus, Convalescence

In brief

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.

Key facts

Study ID

NCT04323800

Run by

Johns Hopkins University

People needed

180

Starts

2020-06-10

Expected to finish

2021-06-22

Last updated by the study team

2022-04-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects must be 18 years of age or older
• 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)

You may not qualify if…

• Receipt of any blood product in past 120 days.
• Medical, psychiatric,cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance.
• Symptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of breath) at time of screening.
• Laboratory evidence of COVID-19 infection at time of screening.
• History or known laboratory evidence of previous COVID-19 infection.
• History of prior reactions to transfusion blood products.
• Inability to complete therapy with the study product within 24 hours after randomization.

Where it is running

• 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 D.C., 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

Full record on ClinicalTrials.gov

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