Early Outpatient Treatment for Covid-19 with Convalescent Plasma

David J. Sullivan; Kelly A. Gebo; Shmuel Shoham; Evan M. Bloch; Bryan Lau; Aarthi G. Shenoy; Giselle S. Mosnaim; Thomas J. Gniadek; Yuriko Fukuta; Bela Patel; Sonya L. Heath; Adam C. Levine; Barry R. Meisenberg; Emily S. Spivak; Shweta Anjan; Moises A. Huaman; Janis E. Blair; Judith S. Currier; James H. Paxton; Jonathan M. Gerber; Joann R. Petrini; Patrick B. Broderick; William Rausch; Marie Elena Cordisco; Jean Hammel; Benjamin Greenblatt; Valerie C. Cluzet; Daniel Cruser; Kevin Oei; Matthew Abinante; Laura L. Hammitt; Catherine G. Sutcliffe; Donald N. Forthal; Martin S. Zand; Edward R. Cachay; Jay S. Raval; Seble G. Kassaye; E. Colin Foster; Michael Roth; Christi E. Marshall; Anusha Yarava; Karen Lane; Nichol A. McBee; Amy L. Gawad; Nicky Karlen; Atika Singh; Daniel E. Ford; Douglas A. Jabs; Lawrence J. Appel; David M. Shade; Stephan Ehrhardt; Sheriza N. Baksh; Oliver Laeyendecker; Andrew Pekosz; Sabra L. Klein; Arturo Casadevall; Aaron A.R. Tobian; Daniel F. Hanley

doi:10.1056/NEJMoa2119657

Early Outpatient Treatment for Covid-19 with Convalescent Plasma

David J. Sullivan, Kelly A. Gebo, Shmuel Shoham, Evan M. Bloch, Bryan Lau, Aarthi G. Shenoy, Giselle S. Mosnaim, Thomas J. Gniadek, Yuriko Fukuta, Bela Patel, Sonya L. Heath, Adam C. Levine, Barry R. Meisenberg, Emily S. Spivak, Shweta Anjan, Moises A. Huaman, Janis E. Blair, Judith S. Currier, James H. Paxton, Jonathan M. GerberJoann R. Petrini, Patrick B. Broderick, William Rausch, Marie Elena Cordisco, Jean Hammel, Benjamin Greenblatt, Valerie C. Cluzet, Daniel Cruser, Kevin Oei, Matthew Abinante, Laura L. Hammitt, Catherine G. Sutcliffe, Donald N. Forthal, Martin S. Zand, Edward R. Cachay, Jay S. Raval, Seble G. Kassaye, E. Colin Foster, Michael Roth, Christi E. Marshall, Anusha Yarava, Karen Lane, Nichol A. McBee, Amy L. Gawad, Nicky Karlen, Atika Singh, Daniel E. Ford, Douglas A. Jabs, Lawrence J. Appel, David M. Shade, Stephan Ehrhardt, Sheriza N. Baksh, Oliver Laeyendecker, Andrew Pekosz, Sabra L. Klein, Arturo Casadevall, Aaron A.R. Tobian, Daniel F. Hanley

Research output: Contribution to journal › Article › peer-review

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.

Original language	English (US)
Pages (from-to)	1700-1711
Number of pages	12
Journal	New England Journal of Medicine
Volume	386
Issue number	18
DOIs	https://doi.org/10.1056/NEJMoa2119657
State	Published - May 5 2022

ASJC Scopus subject areas

General Medicine

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10.1056/NEJMoa2119657

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Sullivan, D. J., Gebo, K. A., Shoham, S., Bloch, E. M., Lau, B., Shenoy, A. G., Mosnaim, G. S., Gniadek, T. J., Fukuta, Y., Patel, B., Heath, S. L., Levine, A. C., Meisenberg, B. R., Spivak, E. S., Anjan, S., Huaman, M. A., Blair, J. E., Currier, J. S., Paxton, J. H., ... Hanley, D. F. (2022). Early Outpatient Treatment for Covid-19 with Convalescent Plasma. New England Journal of Medicine, 386(18), 1700-1711. https://doi.org/10.1056/NEJMoa2119657

Sullivan, DJ , Gebo, KA , Shoham, S , Bloch, EM , Lau, B, Shenoy, AG, Mosnaim, GS, Gniadek, TJ, Fukuta, Y, Patel, B, Heath, SL, Levine, AC, Meisenberg, BR, Spivak, ES, Anjan, S, Huaman, MA, Blair, JE, Currier, JS, Paxton, JH, Gerber, JM, Petrini, JR, Broderick, PB, Rausch, W, Cordisco, ME, Hammel, J, Greenblatt, B, Cluzet, VC, Cruser, D, Oei, K, Abinante, M, Hammitt, LL , Sutcliffe, CG, Forthal, DN, Zand, MS, Cachay, ER, Raval, JS, Kassaye, SG, Foster, EC, Roth, M, Marshall, CE, Yarava, A, Lane, K , McBee, NA, Gawad, AL, Karlen, N, Singh, A, Ford, DE , Jabs, DA , Appel, LJ , Shade, DM , Ehrhardt, S , Baksh, SN, Laeyendecker, O, Pekosz, A , Klein, SL , Casadevall, A , Tobian, AAR & Hanley, DF 2022, 'Early Outpatient Treatment for Covid-19 with Convalescent Plasma', New England Journal of Medicine, vol. 386, no. 18, pp. 1700-1711. https://doi.org/10.1056/NEJMoa2119657

@article{bd968f9ef0f946978fb86f6b1d494337,

title = "Early Outpatient Treatment for Covid-19 with Convalescent Plasma",

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.",

author = "Sullivan, {David J.} and Gebo, {Kelly A.} and Shmuel Shoham and Bloch, {Evan M.} and Bryan Lau and Shenoy, {Aarthi G.} and Mosnaim, {Giselle S.} and Gniadek, {Thomas J.} and Yuriko Fukuta and Bela Patel and Heath, {Sonya L.} and Levine, {Adam C.} and Meisenberg, {Barry R.} and Spivak, {Emily S.} and Shweta Anjan and Huaman, {Moises A.} and Blair, {Janis E.} and Currier, {Judith S.} and Paxton, {James H.} and Gerber, {Jonathan M.} and Petrini, {Joann R.} and Broderick, {Patrick B.} and William Rausch and Cordisco, {Marie Elena} and Jean Hammel and Benjamin Greenblatt and Cluzet, {Valerie C.} and Daniel Cruser and Kevin Oei and Matthew Abinante and Hammitt, {Laura L.} and Sutcliffe, {Catherine G.} and Forthal, {Donald N.} and Zand, {Martin S.} and Cachay, {Edward R.} and Raval, {Jay S.} and Kassaye, {Seble G.} and Foster, {E. Colin} and Michael Roth and Marshall, {Christi E.} and Anusha Yarava and Karen Lane and McBee, {Nichol A.} and Gawad, {Amy L.} and Nicky Karlen and Atika Singh and Ford, {Daniel E.} and Jabs, {Douglas A.} and Appel, {Lawrence J.} and Shade, {David M.} and Stephan Ehrhardt and Baksh, {Sheriza N.} and Oliver Laeyendecker and Andrew Pekosz and Klein, {Sabra L.} and Arturo Casadevall and Tobian, {Aaron A.R.} and Hanley, {Daniel F.}",

note = "Publisher Copyright: Copyright {\textcopyright} 2022 Massachusetts Medical Society",

year = "2022",

month = may,

day = "5",

doi = "10.1056/NEJMoa2119657",

language = "English (US)",

volume = "386",

pages = "1700--1711",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachussetts Medical Society",

number = "18",

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TY - JOUR

T1 - Early Outpatient Treatment for Covid-19 with Convalescent Plasma

AU - Sullivan, David J.

AU - Gebo, Kelly A.

AU - Shoham, Shmuel

AU - Bloch, Evan M.

AU - Lau, Bryan

AU - Shenoy, Aarthi G.

AU - Mosnaim, Giselle S.

AU - Gniadek, Thomas J.

AU - Fukuta, Yuriko

AU - Patel, Bela

AU - Heath, Sonya L.

AU - Levine, Adam C.

AU - Meisenberg, Barry R.

AU - Spivak, Emily S.

AU - Anjan, Shweta

AU - Huaman, Moises A.

AU - Blair, Janis E.

AU - Currier, Judith S.

AU - Paxton, James H.

AU - Gerber, Jonathan M.

AU - Petrini, Joann R.

AU - Broderick, Patrick B.

AU - Rausch, William

AU - Cordisco, Marie Elena

AU - Hammel, Jean

AU - Greenblatt, Benjamin

AU - Cluzet, Valerie C.

AU - Cruser, Daniel

AU - Oei, Kevin

AU - Abinante, Matthew

AU - Hammitt, Laura L.

AU - Sutcliffe, Catherine G.

AU - Forthal, Donald N.

AU - Zand, Martin S.

AU - Cachay, Edward R.

AU - Raval, Jay S.

AU - Kassaye, Seble G.

AU - Foster, E. Colin

AU - Roth, Michael

AU - Marshall, Christi E.

AU - Yarava, Anusha

AU - Lane, Karen

AU - McBee, Nichol A.

AU - Gawad, Amy L.

AU - Karlen, Nicky

AU - Singh, Atika

AU - Ford, Daniel E.

AU - Jabs, Douglas A.

AU - Appel, Lawrence J.

AU - Shade, David M.

AU - Ehrhardt, Stephan

AU - Baksh, Sheriza N.

AU - Laeyendecker, Oliver

AU - Pekosz, Andrew

AU - Klein, Sabra L.

AU - Casadevall, Arturo

AU - Tobian, Aaron A.R.

AU - Hanley, Daniel F.

PY - 2022/5/5

Y1 - 2022/5/5

N2 - 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.

AB - 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.

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U2 - 10.1056/NEJMoa2119657

DO - 10.1056/NEJMoa2119657

M3 - Article

C2 - 35353960

AN - SCOPUS:85129390032

SN - 0028-4793

VL - 386

SP - 1700

EP - 1711

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 18

ER -

Early Outpatient Treatment for Covid-19 with Convalescent Plasma

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