Status:
COMPLETED
Convalescent Plasma to Stem Coronavirus (CSSC-001)
Lead Sponsor:
Johns Hopkins University
Conditions:
Coronavirus
Convalescence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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)
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
June 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2021
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04323800
Start Date
June 10 2020
End Date
June 22 2021
Last Update
April 26 2022
Active Locations (25)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Center for American Indian Health - Whiteriver Office
Whiteriver, Arizona, United States, 85941
3
University of California, San Diego
La Jolla, California, United States, 92093
4
University of California, Los Angeles
Los Angeles, California, United States, 90095