CSSC-004: Convalescent Plasma to Limit Coronavirus-Associated Complications
A Randomized, Double-Blind, Controlled, Phase 2 Study Comparing the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 non-immune) Plasma Among Outpatients with Symptomatic COVID-19
This randomized, double-blind, controlled, phase 2 trial will assess the efficacy and safety of Human Coronavirus Immune Plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms, and duration of nasopharyngeal or oropharyngeal viral shedding. Adults 18 years of age or older, regardless of risk factors for severe illness, may participate. Approximately 1,344 eligible subjects stratified 50:50 in the <65 vs. ≥65 age range will be randomized in a 1:1 ratio to receive either HCIP or control 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.