Convalescent Plasma to Stem Coronavirus (CSSC-001)
Purpose
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.
Conditions
- Coronavirus
- Convalescence
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Subjects must be 18 years of age or older 2. 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. 2. Medical, psychiatric,cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance. 3. Symptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of breath) at time of screening. 4. Laboratory evidence of COVID-19 infection at time of screening. 5. History or known laboratory evidence of previous COVID-19 infection. 6. History of prior reactions to transfusion blood products. 7. Inability to complete therapy with the study product within 24 hours after randomization.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 1:1 ratio
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental High titer anti-SARS-CoV-2 plasma |
Participants with High titer anti-SARS-CoV-2 plasma. |
|
Active Comparator SARS-CoV-2 non-immune plasma |
Participants with SARS-CoV-2 non-immune plasma. |
|
Recruiting Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
Birmingham, Alabama 35294
Center for American Indian Health - Whiteriver Office
Whiteriver, Arizona 85941
Whiteriver, Arizona 85941
University of California, San Diego
La Jolla, California 92093
La Jolla, California 92093
University of California, Los Angeles
Los Angeles, California 90095
Los Angeles, California 90095
University of California, Irvine Health
Orange, California 92868
Orange, California 92868
Western Connecticut Health Network, Danbury Hospital
Danbury, Connecticut 06810
Danbury, Connecticut 06810
Contact:
Marie Elena Cordisco
203-739-7353
Marie Elena Cordisco
203-739-7353
Western Connecticut Health Netowrk, Norwalk Hospital
Norwalk, Connecticut 06856
Norwalk, Connecticut 06856
Contact:
Marie Elena Cordisco
203-739-7353
Marie Elena Cordisco
203-739-7353
MedStar Georgetown University Hospital
Washington, District of Columbia 20007
Washington, District of Columbia 20007
University of Miami Clinical Translational Research Site
Miami, Florida 33136
Miami, Florida 33136
NorthShore University HealthSystem
Evanston, Illinois 60201
Evanston, Illinois 60201
Anne Arundel Medical Center
Annapolis, Maryland 21401
Annapolis, Maryland 21401
The Johns Hopkins University
Baltimore, Maryland 21205
Baltimore, Maryland 21205
University of Massachusetts Worcester
Worcester, Massachusetts 01655
Worcester, Massachusetts 01655
Wayne State University
Detroit, Michigan 48202
Detroit, Michigan 48202
Center for American Indian Health - Gallup Office
Gallup, New Mexico 87301
Gallup, New Mexico 87301
Center for American Indian Health - Shiprock Office
Shiprock, New Mexico 87420
Shiprock, New Mexico 87420
Vassar Brothers Medical Center
Poughkeepsie, New York 12601
Poughkeepsie, New York 12601
Contact:
William Rausch
845-483-6323
William Rausch
845-483-6323
University of Rochester
Rochester, New York 14642
Rochester, New York 14642
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Lifespan/BrownUniversity (Rhode Island Hospital)
Providence, Rhode Island 02903
Providence, Rhode Island 02903
University of Texas Health Science Center at Houston
Houston, Texas 77030
Houston, Texas 77030
More Details
- NCT ID
- NCT04323800
- Status
- Recruiting
- Sponsor
- Johns Hopkins University
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).