Convalescent Plasma to Stem Coronavirus: A Randomized Controlled Double-Blinded Phase 2 Study Comparing the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 non-immune plasma) Among Adults Exposed to COVID-19 (CSSC-001)
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. Adults 18 years of age and older with high-risk exposure and at higher risk for severe illness and/or who are health care personnel with high-risk exposure may participate. We will randomize 150 eligible subjects in a 1:1 ratio to receive either high-titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma).
NOTICE: Online training and downloadable documentation for the CSSC 001 and 004 Trials has been moved to https://biostraining.com/COVID/. Please register for the new site for access to these. Any already completed trainings will be filed in the eTMF and do not need to be re-taken.