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

Abstract: There are not any scientifically proven or approved therapies for COVID-19. Convalescent plasma (CP), whichis plasma that is obtained from people who have recovered from COVID-19, contains antibodies to SARS-CoV-2, the virus that causes this disease. CP has a long and storied history of improving symptoms and mortalityfrom other pandemic diseases, such as 1918 and 2009 influenza and SARS, as well as a myriad of other toxin-mediated and infectious diseases. Thus, CP is a rationally based and readily available therapeutic option forCOVID-19. There are thousands of people who have recovered from COVID-19 in the New York City area whohave donated their plasma to help others who are suffering from this disease. This project is a collaborativerandomized blinded placebo-controlled trial to evaluate the efficacy of treatment with CP in hospitalized patientswith COVID-19 that is being conducted at three New York University (NYU) Langone Health hospitals inManhattan, Brooklyn and Long Island, Bellevue Hospital Center, and three Montefiore Medical Center (MMC)hospitals in the Bronx. We designed and launched this trial as the pandemic surged in NYC by rapidly developinga multicenter, well-powered Phase 2 trial via regional collaborations established by Einstein-Montefiore andNYU-Langone CTSAs with support from the New York Blood Center (NYBC). The hypothesis underpinning thetrial is that compared to placebo, administration of CP will avert respiratory deterioration, the main cause of deathin patients with COVID-19. The specific aims of this project are: 1) To examine whether CP decreases thelikelihood of respiratory deterioration in patients hospitalized for COVID-19 compared to placebo (saline solution,SS) at 14 days from administration, and 2) To identify associations between quantitative and qualitative SARS-CoV-2 antibody levels and clinical outcomes in patients hospitalized for COVID-19 who receive CP and placebo.The public health benefit of proof of CP efficacy against COVID-19, which has already caused 338,000 infectionsand 21,845 deaths in the United States and 187,250 infections and 1,127 deaths in New York City would be atremendous and public health advance that could save thousands of lives.