Safety Update

Abstract

Objective To provide an update on key safety metrics after transfusion of convalescent plasma in hospitalized coronavirus 2019 (COVID-19) patients, having previously demonstrated safety in 5000 hospitalized patients. Patients and Methods From April 3 to June 2, 2020, the US Food and Drug Administration Expanded Access Program for COVID-19 convalescent plasma transfused a convenience sample of 20,000 hospitalized patients with COVID-19 convalescent plasma. Results The incidence of all serious adverse events was low; these included transfusion reactions (n = 78; <1%), thromboembolic or thrombotic events (n = 113; <1%), and cardiac events (n=677, ~3%). Notably, the vast majority of the thromboembolic or thrombotic events (n=75) and cardiac events (n=597) were judged to be unrelated to the plasma transfusion per se. The 7-day mortality rate was 13.0% (12.5%, 13.4%), and was higher among more critically ill patients relative to less ill counterparts, including patients admitted to the intensive care unit versus those not admitted (15.6 vs 9.3%), mechanically ventilated versus not ventilated (18.3% vs 9.9%), and with septic shock or multiple organ dysfunction/failure versus those without dysfunction/failure (21.7% vs 11.5%). Conclusion These updated data provide robust evidence that transfusion of convalescent plasma is safe in hospitalized patients with COVID-19, and support the notion that earlier administration of plasma within the clinical course of COVID-19 is more likely to reduce mortality.

Convalescent plasma is ineffective for covid-19

“…10 The authors of the safety update on the first 20 000 recipients said their results provided "robust evidence that transfusion of CP [convalescent plasma] is safe." 11 However, close examination reveals that adjudication of the "relatedness" of serious adverse thrombotic and cardiac events was conducted by the treating physician, with no defined protocol and no independent review. 11 Most of the 677 cardiac events (88.2%) and 113 thrombotic events (66.3%) were judged not to be related to transfusion, and these events were therefore excluded from the reported adverse event rates.…”

Overview of the Pathogenesis and Treatment of SARS-CoV-2 for Clinicians: A Comprehensive Literature Review

“…However, this trial was terminated early and therefore the sample was insufficient to determine subtle clinical differences among the treatment arms [48]. In addition, a safety analysis conducted on 20,000 patients who received convalescent plasma through the National Extended Access Program revealed that although adverse events were uncommon (<1%), they did include transfusionassociated circulatory overload (TACO), transfusion-related acute lung injury (TRALI), allergic reactions, and death [49].…”

Convalescent plasma appears efficacious and safe in COVID-19

“…33 The trial was further expanded to over 20,000 patients and the latest update demonstrated a mortality rate of 8.6%, which was far less than the previous findings of 14.9%. 34 Although these trials successfully demonstrated the safety of CP therapy, its efficacy was not studied. These trials also lacked a control arm against which to compare the findings.…”