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.


  • Coronavirus
  • Convalescence


Eligible Ages
Over 18 Years
Eligible Genders
Accepts Healthy Volunteers

Inclusion Criteria

  1. 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

  1. 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 2
Study Type
Intervention Model
Parallel Assignment
Intervention Model Description
1:1 ratio
Primary Purpose
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
High titer anti-SARS-CoV-2 plasma
Participants with High titer anti-SARS-CoV-2 plasma.
  • Biological: Anti- SARS-CoV-2 Plasma
    SARS-CoV-2 convalescent plasma (1 unit; ~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320
Active Comparator
SARS-CoV-2 non-immune plasma
Participants with SARS-CoV-2 non-immune plasma.
  • Biological: SARS-CoV-2 non-immune Plasma
    Normal human plasma collected prior to December 2019

Recruiting Locations

More Details

Active, not recruiting
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).