tetano
Editor, Senior Moderator
N Engl J Med
. 2022 Mar 30.
doi: 10.1056/NEJMoa2119657. Online ahead of print.
Early Outpatient Treatment for Covid-19 with Convalescent Plasma
David J Sullivan[SUP] 1 [/SUP], Kelly A Gebo[SUP] 1 [/SUP], Shmuel Shoham[SUP] 1 [/SUP], Evan M Bloch[SUP] 1 [/SUP], Bryan Lau[SUP] 1 [/SUP], Aarthi G Shenoy[SUP] 1 [/SUP], Giselle S Mosnaim[SUP] 1 [/SUP], Thomas J Gniadek[SUP] 1 [/SUP], Yuriko Fukuta[SUP] 1 [/SUP], Bela Patel[SUP] 1 [/SUP], Sonya L Heath[SUP] 1 [/SUP], Adam C Levine[SUP] 1 [/SUP], Barry R Meisenberg[SUP] 1 [/SUP], Emily S Spivak[SUP] 1 [/SUP], Shweta Anjan[SUP] 1 [/SUP], Moises A Huaman[SUP] 1 [/SUP], Janis E Blair[SUP] 1 [/SUP], Judith S Currier[SUP] 1 [/SUP], James H Paxton[SUP] 1 [/SUP], Jonathan M Gerber[SUP] 1 [/SUP], Joann R Petrini[SUP] 1 [/SUP], Patrick B Broderick[SUP] 1 [/SUP], William Rausch[SUP] 1 [/SUP], Marie-Elena Cordisco[SUP] 1 [/SUP], Jean Hammel[SUP] 1 [/SUP], Benjamin Greenblatt[SUP] 1 [/SUP], Valerie C Cluzet[SUP] 1 [/SUP], Daniel Cruser[SUP] 1 [/SUP], Kevin Oei[SUP] 1 [/SUP], Matthew Abinante[SUP] 1 [/SUP], Laura L Hammitt[SUP] 1 [/SUP], Catherine G Sutcliffe[SUP] 1 [/SUP], Donald N Forthal[SUP] 1 [/SUP], Martin S Zand[SUP] 1 [/SUP], Edward R Cachay[SUP] 1 [/SUP], Jay S Raval[SUP] 1 [/SUP], Seble G Kassaye[SUP] 1 [/SUP], E Colin Foster[SUP] 1 [/SUP], Michael Roth[SUP] 1 [/SUP], Christi E Marshall[SUP] 1 [/SUP], Anusha Yarava[SUP] 1 [/SUP], Karen Lane[SUP] 1 [/SUP], Nichol A McBee[SUP] 1 [/SUP], Amy L Gawad[SUP] 1 [/SUP], Nicky Karlen[SUP] 1 [/SUP], Atika Singh[SUP] 1 [/SUP], Daniel E Ford[SUP] 1 [/SUP], Douglas A Jabs[SUP] 1 [/SUP], Lawrence J Appel[SUP] 1 [/SUP], David M Shade[SUP] 1 [/SUP], Stephan Ehrhardt[SUP] 1 [/SUP], Sheriza N Baksh[SUP] 1 [/SUP], Oliver Laeyendecker[SUP] 1 [/SUP], Andrew Pekosz[SUP] 1 [/SUP], Sabra L Klein[SUP] 1 [/SUP], Arturo Casadevall[SUP] 1 [/SUP], Aaron A R Tobian[SUP] 1 [/SUP], Daniel F Hanley[SUP] 1 [/SUP]
Affiliations
Abstract
Background: Polyclonal convalescent plasma may be obtained from donors who have recovered from coronavirus disease 2019 (Covid-19). The efficacy of this plasma in preventing serious complications in outpatients with recent-onset Covid-19 is uncertain.
Methods: In this multicenter, double-blind, randomized, controlled trial, we evaluated the efficacy and safety of Covid-19 convalescent plasma, as compared with control plasma, in symptomatic adults (≥18 years of age) who had tested positive for severe acute respiratory syndrome coronavirus 2, regardless of their risk factors for disease progression or vaccination status. Participants were enrolled within 8 days after symptom onset and received a transfusion within 1 day after randomization. The primary outcome was Covid-19-related hospitalization within 28 days after transfusion.
Results: Participants were enrolled from June 3, 2020, through October 1, 2021. A total of 1225 participants underwent randomization, and 1181 received a transfusion. In the prespecified modified intention-to-treat analysis that included only participants who received a transfusion, the primary outcome occurred in 17 of 592 participants (2.9%) who received convalescent plasma and 37 of 589 participants (6.3%) who received control plasma (absolute risk reduction, 3.4 percentage points; 95% confidence interval, 1.0 to 5.8; P = 0.005), which corresponded to a relative risk reduction of 54%. Evidence of efficacy in vaccinated participants cannot be inferred from these data because 53 of the 54 participants with Covid-19 who were hospitalized were unvaccinated and 1 participant was partially vaccinated. A total of 16 grade 3 or 4 adverse events (7 in the convalescent-plasma group and 9 in the control-plasma group) occurred in participants who were not hospitalized.
Conclusions: In participants with Covid-19, most of whom were unvaccinated, the administration of convalescent plasma within 9 days after the onset of symptoms reduced the risk of disease progression leading to hospitalization. (Funded by the Department of Defense and others; CSSC-004 ClinicalTrials.gov number, NCT04373460.).
. 2022 Mar 30.
doi: 10.1056/NEJMoa2119657. Online ahead of print.
Early Outpatient Treatment for Covid-19 with Convalescent Plasma
David J Sullivan[SUP] 1 [/SUP], Kelly A Gebo[SUP] 1 [/SUP], Shmuel Shoham[SUP] 1 [/SUP], Evan M Bloch[SUP] 1 [/SUP], Bryan Lau[SUP] 1 [/SUP], Aarthi G Shenoy[SUP] 1 [/SUP], Giselle S Mosnaim[SUP] 1 [/SUP], Thomas J Gniadek[SUP] 1 [/SUP], Yuriko Fukuta[SUP] 1 [/SUP], Bela Patel[SUP] 1 [/SUP], Sonya L Heath[SUP] 1 [/SUP], Adam C Levine[SUP] 1 [/SUP], Barry R Meisenberg[SUP] 1 [/SUP], Emily S Spivak[SUP] 1 [/SUP], Shweta Anjan[SUP] 1 [/SUP], Moises A Huaman[SUP] 1 [/SUP], Janis E Blair[SUP] 1 [/SUP], Judith S Currier[SUP] 1 [/SUP], James H Paxton[SUP] 1 [/SUP], Jonathan M Gerber[SUP] 1 [/SUP], Joann R Petrini[SUP] 1 [/SUP], Patrick B Broderick[SUP] 1 [/SUP], William Rausch[SUP] 1 [/SUP], Marie-Elena Cordisco[SUP] 1 [/SUP], Jean Hammel[SUP] 1 [/SUP], Benjamin Greenblatt[SUP] 1 [/SUP], Valerie C Cluzet[SUP] 1 [/SUP], Daniel Cruser[SUP] 1 [/SUP], Kevin Oei[SUP] 1 [/SUP], Matthew Abinante[SUP] 1 [/SUP], Laura L Hammitt[SUP] 1 [/SUP], Catherine G Sutcliffe[SUP] 1 [/SUP], Donald N Forthal[SUP] 1 [/SUP], Martin S Zand[SUP] 1 [/SUP], Edward R Cachay[SUP] 1 [/SUP], Jay S Raval[SUP] 1 [/SUP], Seble G Kassaye[SUP] 1 [/SUP], E Colin Foster[SUP] 1 [/SUP], Michael Roth[SUP] 1 [/SUP], Christi E Marshall[SUP] 1 [/SUP], Anusha Yarava[SUP] 1 [/SUP], Karen Lane[SUP] 1 [/SUP], Nichol A McBee[SUP] 1 [/SUP], Amy L Gawad[SUP] 1 [/SUP], Nicky Karlen[SUP] 1 [/SUP], Atika Singh[SUP] 1 [/SUP], Daniel E Ford[SUP] 1 [/SUP], Douglas A Jabs[SUP] 1 [/SUP], Lawrence J Appel[SUP] 1 [/SUP], David M Shade[SUP] 1 [/SUP], Stephan Ehrhardt[SUP] 1 [/SUP], Sheriza N Baksh[SUP] 1 [/SUP], Oliver Laeyendecker[SUP] 1 [/SUP], Andrew Pekosz[SUP] 1 [/SUP], Sabra L Klein[SUP] 1 [/SUP], Arturo Casadevall[SUP] 1 [/SUP], Aaron A R Tobian[SUP] 1 [/SUP], Daniel F Hanley[SUP] 1 [/SUP]
Affiliations
- PMID: 35353960
- DOI: 10.1056/NEJMoa2119657
Abstract
Background: Polyclonal convalescent plasma may be obtained from donors who have recovered from coronavirus disease 2019 (Covid-19). The efficacy of this plasma in preventing serious complications in outpatients with recent-onset Covid-19 is uncertain.
Methods: In this multicenter, double-blind, randomized, controlled trial, we evaluated the efficacy and safety of Covid-19 convalescent plasma, as compared with control plasma, in symptomatic adults (≥18 years of age) who had tested positive for severe acute respiratory syndrome coronavirus 2, regardless of their risk factors for disease progression or vaccination status. Participants were enrolled within 8 days after symptom onset and received a transfusion within 1 day after randomization. The primary outcome was Covid-19-related hospitalization within 28 days after transfusion.
Results: Participants were enrolled from June 3, 2020, through October 1, 2021. A total of 1225 participants underwent randomization, and 1181 received a transfusion. In the prespecified modified intention-to-treat analysis that included only participants who received a transfusion, the primary outcome occurred in 17 of 592 participants (2.9%) who received convalescent plasma and 37 of 589 participants (6.3%) who received control plasma (absolute risk reduction, 3.4 percentage points; 95% confidence interval, 1.0 to 5.8; P = 0.005), which corresponded to a relative risk reduction of 54%. Evidence of efficacy in vaccinated participants cannot be inferred from these data because 53 of the 54 participants with Covid-19 who were hospitalized were unvaccinated and 1 participant was partially vaccinated. A total of 16 grade 3 or 4 adverse events (7 in the convalescent-plasma group and 9 in the control-plasma group) occurred in participants who were not hospitalized.
Conclusions: In participants with Covid-19, most of whom were unvaccinated, the administration of convalescent plasma within 9 days after the onset of symptoms reduced the risk of disease progression leading to hospitalization. (Funded by the Department of Defense and others; CSSC-004 ClinicalTrials.gov number, NCT04373460.).
