Transfusion reactions associated with COVID-19 convalescent plasma therapy for SARSCoV-2 across the Mount Sinai Health System in New York City

ABSTRACT

Background/Case Studies To date, convalescent plasma for the treatment of SARS-CoV-2 has shown effectiveness in severely ill patients in reducing mortality. While studies have demonstrated a low risk of serious adverse events, the comprehensive incidence and nature of the spectrum of transfusion reactions to convalescent plasma is unknown. Here, we retrospectively examine 427 inpatient convalescent plasma transfusions to determine incidence and types of reactions, as well as clinical parameters and risk factors associated with transfusion reactions. Study Design/Methods: Retrospective analysis was performed for 427 transfusions to 215 COVID-19 patients within the Mount Sinai Health System (MSHS), through eIND and EAP approval pathways by the FDA. Transfusions were blindly evaluated by two reviewers and adjudicated by a third reviewer in discordant cases. Patient demographics, clinical, and laboratory parameters were compared and analyzed. Statistical analysis was performed determine the significance of these parameters and univariate logistic regression analysis was performed to assess which independent variables were correlated with a transfusion reaction. Results/Findings: Fifty-five reactions from 427 transfusion events were identified (12.9% incidence), thirteen of which were attributed to transfusion (3.1% incidence). Reactions were classified as underlying COVID-19 (76%), febrile non-hemolytic (10.9%), transfusion-associated circulatory overload (9.1%), allergic (1.8%), and hypotensive (1.8%) reactions. Statistical analysis identified increased transfusion reaction risk for ABO blood group B, Sequential Organ Failure Assessment scores of 12-13, or a cancer diagnosis. A decreased risk was identified for patients in the age group of 80-89 years. Conclusions: Our findings support the use of convalescent plasma as a safe therapeutic option from a transfusion reaction perspective, in the setting of COVID-19. Further studies are needed to confirm the clinical significance of ABO group B, cancer diagnosis, age, and predisposing disease severity in the incidence of transfusion reaction events.