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
More Details
- NCT ID
- NCT04323800
- Status
- Active, not 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).