tetano
Editor, Senior Moderator
Mayo Clin Proc
. 2020 Sep;95(9):1888-1897.
doi: 10.1016/j.mayocp.2020.06.028. Epub 2020 Jul 19.
Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients
Michael J Joyner[SUP] 1 [/SUP], Katelyn A Bruno[SUP] 2 [/SUP], Stephen A Klassen[SUP] 3 [/SUP], Katie L Kunze[SUP] 4 [/SUP], Patrick W Johnson[SUP] 5 [/SUP], Elizabeth R Lesser[SUP] 5 [/SUP], Chad C Wiggins[SUP] 3 [/SUP], Jonathon W Senefeld[SUP] 3 [/SUP], Allan M Klompas[SUP] 3 [/SUP], David O Hodge[SUP] 5 [/SUP], John R A Shepherd[SUP] 3 [/SUP], Robert F Rea[SUP] 6 [/SUP], Emily R Whelan[SUP] 2 [/SUP], Andrew J Clayburn[SUP] 3 [/SUP], Matthew R Spiegel[SUP] 5 [/SUP], Sarah E Baker[SUP] 3 [/SUP], Kathryn F Larson[SUP] 3 [/SUP], Juan G Ripoll[SUP] 3 [/SUP], Kylie J Andersen[SUP] 3 [/SUP], Matthew R Buras[SUP] 4 [/SUP], Matthew N P Vogt[SUP] 3 [/SUP], Vitaly Herasevich[SUP] 3 [/SUP], Joshua J Dennis[SUP] 3 [/SUP], Riley J Regimbal[SUP] 3 [/SUP], Philippe R Bauer[SUP] 7 [/SUP], Janis E Blair[SUP] 8 [/SUP], Camille M van Buskirk[SUP] 9 [/SUP], Jeffrey L Winters[SUP] 9 [/SUP], James R Stubbs[SUP] 9 [/SUP], Noud van Helmond[SUP] 10 [/SUP], Brian P Butterfield[SUP] 3 [/SUP], Matthew A Sexton[SUP] 3 [/SUP], Juan C Diaz Soto[SUP] 3 [/SUP], Nigel S Paneth[SUP] 11 [/SUP], Nicole C Verdun[SUP] 12 [/SUP], Peter Marks[SUP] 12 [/SUP], Arturo Casadevall[SUP] 13 [/SUP], DeLisa Fairweather[SUP] 2 [/SUP], Rickey E Carter[SUP] 5 [/SUP], R Scott Wright[SUP] 14 [/SUP]
Affiliations
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.
. 2020 Sep;95(9):1888-1897.
doi: 10.1016/j.mayocp.2020.06.028. Epub 2020 Jul 19.
Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients
Michael J Joyner[SUP] 1 [/SUP], Katelyn A Bruno[SUP] 2 [/SUP], Stephen A Klassen[SUP] 3 [/SUP], Katie L Kunze[SUP] 4 [/SUP], Patrick W Johnson[SUP] 5 [/SUP], Elizabeth R Lesser[SUP] 5 [/SUP], Chad C Wiggins[SUP] 3 [/SUP], Jonathon W Senefeld[SUP] 3 [/SUP], Allan M Klompas[SUP] 3 [/SUP], David O Hodge[SUP] 5 [/SUP], John R A Shepherd[SUP] 3 [/SUP], Robert F Rea[SUP] 6 [/SUP], Emily R Whelan[SUP] 2 [/SUP], Andrew J Clayburn[SUP] 3 [/SUP], Matthew R Spiegel[SUP] 5 [/SUP], Sarah E Baker[SUP] 3 [/SUP], Kathryn F Larson[SUP] 3 [/SUP], Juan G Ripoll[SUP] 3 [/SUP], Kylie J Andersen[SUP] 3 [/SUP], Matthew R Buras[SUP] 4 [/SUP], Matthew N P Vogt[SUP] 3 [/SUP], Vitaly Herasevich[SUP] 3 [/SUP], Joshua J Dennis[SUP] 3 [/SUP], Riley J Regimbal[SUP] 3 [/SUP], Philippe R Bauer[SUP] 7 [/SUP], Janis E Blair[SUP] 8 [/SUP], Camille M van Buskirk[SUP] 9 [/SUP], Jeffrey L Winters[SUP] 9 [/SUP], James R Stubbs[SUP] 9 [/SUP], Noud van Helmond[SUP] 10 [/SUP], Brian P Butterfield[SUP] 3 [/SUP], Matthew A Sexton[SUP] 3 [/SUP], Juan C Diaz Soto[SUP] 3 [/SUP], Nigel S Paneth[SUP] 11 [/SUP], Nicole C Verdun[SUP] 12 [/SUP], Peter Marks[SUP] 12 [/SUP], Arturo Casadevall[SUP] 13 [/SUP], DeLisa Fairweather[SUP] 2 [/SUP], Rickey E Carter[SUP] 5 [/SUP], R Scott Wright[SUP] 14 [/SUP]
Affiliations
- PMID: 32861333
- DOI: 10.1016/j.mayocp.2020.06.028
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.