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 to person with COVID-19 within 96 hours of enrollment (and 120 hours of receipt of plasma) defined as:
- 1 Living in the same household as, being an intimate partner of, or providing care in a non-healthcare setting (such as a home) for a person with symptomatic laboratory-confirmed COVID-19 infection without using recommended precautions for home care and home isolation.
- 2 HCP who have had prolonged close contact with patients with COVID-19 who were not wearing a face mask while HCP nose and mouth were exposed to material potentially infectious with the virus causing COVID-19.
- 3 Being present in the room for procedures that generate aerosols or during which respiratory secretions are likely to be poorly controlled (e.g., cardiopulmonary resuscitation, intubation, extubation, bronchoscopy, nebulizer therapy, sputum induction) on patients with COVID-19 when the healthcare providers' eyes, nose, or mouth were not protected.
- 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 enrollment.
- 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).