The proposed administrative supplement to the Miami Clinical and Translational Science Institute (CTSI) is a randomized 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-19 patients. However, this trial was developed to obtain scientific evidence to support or reject the hypothesis that CP may be a therapeutic option for COVID-19. The hypothesis underpinning this trial is that compared to placebo, administration of CP will avert respiratory deterioration, the main cause of death, and improve clinical status in patients hospitalized with COVID-19. This trial is being conducted across several sites that have experienced 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 of the global hot spots. This study is within the scope of the existing CTSA award, with its focus on network trials and rapid site initiation and team science, and leverages the Miami CTSI?s focus on mobilizing resources in response to rapidly emerging infectious diseases, proven during the Zika virus in 2015. Miami will serve as a new site in this quickly designed and launched trial, building upon the work already done in NYC to develop a multicenter, well-powered Phase 2 trial via regional collaborations and CTSA consortium partnerships.
The proposed project is a randomized blinded placebo-controlled trial to evaluate the efficacy of treatment with convalescent plasma (CP) in hospitalized patients with COVID-19. The hypothesis underpinning this trial is that compared to placebo, administration of CP will avert respiratory deterioration, the main cause of death, and improve clinical status in patients hospitalized with COVID-19. The study has the potential to greatly impact the manner in which COVID-19 is treated in hospitalized patients, as well as impact the course of vaccine development, and could save lives around the world.
