ABSTRACT
Rationale:The outbreak of COVID-19 in March of 2020 led to the emergent search for treatment options. Passive immune therapy with COVID-19 convalescent plasma (CCP) therapy was utilized as an investigational therapy. We designed an open label study and received an investigational new drug (IND) number from the Food and Drug Administration for the study on April 11, 2020. Methods:Patients with severe COVID-19 were enrolled and identical ABO CCP was administered. CCP was collected from recovered COVID-19 patients by our hospital blood donor services in line with FDA guidelines. Patients could receive up to three doses of CCP and each dose came from a different donor to potentiate therapeutic response. Subjects were followed for 28 days after infusion of COVID-19 convalescent plasma (CCP) in hospital or with weekly phone calls if discharged home. Results:45 patients received CCP through the study period of April 24th through August 21st. The median age was 60 (range: 16-87), and two thirds were male (n=30) with Hispanic predominance (58%). Patients also received supplemental therapies such as remdesivir, tocilizumab, dexamethasone, and inhaled nitric oxide. Twenty-six recipients received 1 dose, 12 received 2 doses, and 7 received 3 doses of CCP all of which were collected internally by the hospital blood donor center. 22 recipients were O positive, 17 were A positive, and 6 were B positive. During their hospital course, 18 patients were on mechanical ventilation, 3 of which were on ECMO, 19 were on high-flow nasal cannula, and 8 were on low-flow nasal cannula as the highest level of oxygen therapy. At the 28 day follow up, 14 patients were deceased (31%), 4 (9%) were still hospitalized, and 27 (60%) were discharged home. Two patients had a suspected transfusion related reaction that resolved with supportive care including diphenhydramine and furosemide. Conclusion:We designed and implemented a pragmatic study to provide a treatment option for patients hospitalized with COVID-19. Sixty percent of our very sick study population survived to hospital discharge and there were only two transient infusion reactions. While larger studies with a control group are necessary to more clearly evaluate the benefit of CCP in COVID-19, our study lays the foundation for the rapid implementation of a Convalescent Plasma Program for possible future pandemics as a bridge to vaccine and therapeutic trials.