Convalescent Plasma to Stem Coronavirus (CSSC-001)
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.
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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)
- 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.
- Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 1:1 ratio
- Primary Purpose
- Triple (Participant, Care Provider, Investigator)
High titer anti-SARS-CoV-2 plasma
|Participants with High titer anti-SARS-CoV-2 plasma.||
SARS-CoV-2 non-immune plasma
|Participants with SARS-CoV-2 non-immune plasma.||
- Johns Hopkins University
Study ContactShmuel Shoham, MD
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).