Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients

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.

Figure 1

Participation in the US COVID-19 Convalescent Plasma Expanded Access Program (EAP) including data extracted on June 11, 2020. Choropleth map displaying the number of cumulatively enrolled patients in the EAP within each state, with lower enrollment values displayed in a lighter hue of green and higher enrollment values displayed in a darker hue of green. Registered acute care facilities are represented as filled yellow circles, with larger circles indicating greater number of registered facilities within the metropolitan area of a city. The choropleth map does not display data from US territories, including registered facilities in Puerto Rico, Guam, and Northern Mariana Islands.

Figure 2

Seven-day mortality rate in patients transfused with COVID-19 convalescent plasma stratified by week since initiation of the US COVID-19 Convalescent Plasma Expanded Access Program (EAP). Each green bar indicates the 7-day mortality rate stratified by the patients enrolled during a given week since the initiation of the EAP.