Early Outpatient Treatment for Covid-19 with Convalescent Plasma
Sullivan et al.
, Early Outpatient Treatment for Covid-19 with Convalescent Plasma
, New England Journal of Medicine, doi:10.1056/NEJMoa2119657 (date from earlier preprint), NCT04373460
RCT 1,181 outpatients in the USA, mean 6 days from symptom onset, showing lower hospitalization with treatment. NCT04373460 (history)
risk of death, 85.7% lower, RR 0.14, p = 0.12, treatment 0 of 592 (0.0%), control 3 of 589 (0.5%), NNT 196, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of ICU admission, 25.4% lower, RR 0.75, p = 0.73, treatment 3 of 592 (0.5%), control 4 of 589 (0.7%), NNT 580.
risk of hospitalization, 54.3% lower, RR 0.46, p = 0.005, treatment 17 of 592 (2.9%), control 37 of 589 (6.3%), NNT 29.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Sullivan et al., 21 Dec 2021, Double Blind Randomized Controlled Trial, USA, peer-reviewed, 58 authors, study period 3 June, 2020 - 1 October, 2021, average treatment delay 6.0 days, trial NCT04373460 (history)
Abstract: T h e n e w e ng l a n d j o u r na l o f m e dic i n e
Early Outpatient Treatment for Covid-19
with Convalescent Plasma
D.J. Sullivan, K.A. Gebo, S. Shoham, E.M. Bloch, B. Lau, A.G. Shenoy,
G.S. Mosnaim, T.J. Gniadek, Y. Fukuta, B. Patel, S.L. Heath, A.C. Levine,
B.R. Meisenberg, E.S. Spivak, S. Anjan, M.A. Huaman, J.E. Blair, J.S. Currier,
J.H. Paxton, J.M. Gerber, J.R. Petrini, P.B. Broderick, W. Rausch, M.-E. Cordisco,
J. Hammel, B. Greenblatt, V.C. Cluzet, D. Cruser, K. Oei, M. Abinante,
L.L. Hammitt, C.G. Sutcliffe, D.N. Forthal, M.S. Zand, E.R. Cachay, J.S. Raval,
S.G. Kassaye, E.C. Foster, M. Roth, C.E. Marshall, A. Yarava, K. Lane, N.A. McBee,
A.L. Gawad, N. Karlen, A. Singh, D.E. Ford, D.A. Jabs, L.J. Appel, D.M. Shade,
S. Ehrhardt, S.N. Baksh, O. Laeyendecker, A. Pekosz, S.L. Klein, A. Casadevall,
A.A.R. Tobian, and D.F. Hanley
A BS T R AC T
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.
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.
The authors’ full names, academic degrees, and affiliations are listed in the Appendix. Dr. Sullivan can be contacted at
email@example.com or at Rm. W4606, Johns
Hopkins Bloomberg School of Public
Health, Department of Molecular Microbiology and Immunology, 615 N. Wolfe St.,
Baltimore, MD 21205.
Drs. Sullivan, Gebo, Casadevall, Tobian,
and Hanley contributed equally to this
This article was published on March 30,
2022, at NEJM.org.
Copyright © 2022 Massachusetts Medical Society.
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 controlplasma group) occurred in participants who were not hospitalized.
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;..
is less effective
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