Convalescent Plasma to Limit Coronavirus Associated Complications: Randomized Blinded Phase 2 Study Comparing Efficacy and Safety of Anti-SARS-CoV-2 Plasma to Placebo in COVID-19 Hospitalized Patients

PROJECT Summary: The proposed administrative supplement to the Miami Clinical and Translational Science Institute (CTSI) is arandomized blinded placebo-controlled trial to evaluate the efficacy of treatment with convalescent plasma(CP) in hospitalized patients with COVID-19. Studies have shown that CP is safe for transfusion in COVID-19patients. However, this trial was developed to obtain scientific evidence to support or reject the hypothesis thatCP may be a therapeutic option for COVID-19. The hypothesis underpinning this trial is that compared toplacebo, administration of CP will avert respiratory deterioration, the main cause of death, and improve clinicalstatus in patients hospitalized with COVID-19. This trial is being conducted across several sites that haveexperienced rapidly rising numbers of COVID-19 cases, including Miami, Florida, New York City, New York,and Houston Texas. Miami is the new epicenter of the COVID-19 pandemic in the United States, and one ofthe global hot spots. This study is within the scope of the existing CTSA award, with its focus on network trialsand rapid site initiation and team science, and leverages the Miami CTSI's focus on mobilizing resources inresponse to rapidly emerging infectious diseases, proven during the Zika virus in 2015. Miami will serve as anew site in this quickly designed and launched trial, building upon the work already done in NYC to develop amulticenter, well-powered Phase 2 trial via regional collaborations and CTSA consortium partnerships.