Convalescent Plasma to Stem Coronavirus (CSSC-001)
- Conditions
- ConvalescenceCoronavirus
- Interventions
- Biological: Anti- SARS-CoV-2 PlasmaBiological: SARS-CoV-2 non-immune Plasma
- Registration Number
- NCT04323800
- Lead Sponsor
- Johns Hopkins University
- 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 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High titer anti-SARS-CoV-2 plasma Anti- SARS-CoV-2 Plasma Participants with High titer anti-SARS-CoV-2 plasma. SARS-CoV-2 non-immune plasma SARS-CoV-2 non-immune Plasma Participants with SARS-CoV-2 non-immune plasma.
- Primary Outcome Measures
Name Time Method Efficacy of Treatment at Day 28 as Assessed by Number of Participants Who Develop SARS-Cov-2 Infection Day 28 Comparison of proportions of cumulative incidence of development of SARS-Cov-2 infection (symptoms compatible with infection and/or + molecular testing) regardless of disease severity, following high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to COVID-19.
Safety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Number of Participants With "Serious Adverse Events" Up to Day 28 Number of participants with serious adverse events categorized as either severe infusion reactions or Acute Respiratory Distress Syndrome during the study period.
Safety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Cumulative Incidence of Grade 3 and 4 Adverse Events Up to Day 28 Cumulative incidence of grade 3 and 4 adverse events during the study period evaluated as events per 100 person-years will be used to assess safety of the intervention.
- Secondary Outcome Measures
Name Time Method Number of Participants With Severe Disease Up to 28 days Number of participants with severe disease between the anti-SARS-CoV-2 convalescent plasma and control groups. Severity of disease will be measured using the number of participants with any of the disease severity categories below:
1. Death
2. Requiring mechanical ventilation and/or in ICU
3. non-ICU hospitalization, requiring supplemental oxygen
4. non-ICU hospitalization, not requiring supplemental oxygen
Trial Locations
- Locations (25)
University of Miami
🇺🇸Coral Gables, Florida, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
NorthShore University HealthSystem
🇺🇸Evanston, Illinois, United States
MedStar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
Center for American Indian Health - Whiteriver Office
🇺🇸Whiteriver, Arizona, United States
Western Connecticut Health Network, Danbury Hospital
🇺🇸Danbury, Connecticut, United States
The Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of California, Irvine Health
🇺🇸Orange, California, United States
University of Massachusetts Worcester
🇺🇸Worcester, Massachusetts, 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 New Mexico Health Sciences Center
🇺🇸Albuquerque, New Mexico, United States
University of Rochester
🇺🇸Rochester, New York, United States
Lifespan/BrownUniversity (Rhode Island Hospital)
🇺🇸Providence, Rhode Island, United States
Western Connecticut Health Netowrk, Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
University of California, San Diego
🇺🇸La Jolla, California, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Miami Clinical Translational Research Site
🇺🇸Miami, Florida, United States
Wayne State University
🇺🇸Detroit, Michigan, 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