A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia
RCT 333 hospitalized patients in Argentina, 228 treated with convalescent plasma, showing no significant differences in clinical status or mortality.
risk of death, 4.1% lower, RR 0.96, p = 1.00, treatment 25 of 228 (11.0%), control 12 of 105 (11.4%), NNT 216.
risk of 7-point scale, 19.0% lower, OR 0.81, p = 0.40, treatment 228, control 105, RR approximated with OR.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Simonovich et al., 24 Nov 2020, Randomized Controlled Trial, Argentina, peer-reviewed, 39 authors, average treatment delay 8.0 days, trial NCT04383535 (history)
n e w e ng l a n d j o u r na l
m e dic i n e
A Randomized Trial of Convalescent Plasma
in Covid-19 Severe Pneumonia
V.A. Simonovich, L.D. Burgos Pratx, P. Scibona, M.V. Beruto, M.G. Vallone,
C. Vázquez, N. Savoy, D.H. Giunta, L.G. Pérez, M..L. Sánchez, A.V. Gamarnik,
D.S. Ojeda, D.M. Santoro, P.J. Camino, S. Antelo, K. Rainero, G.P. Vidiella,
E.A. Miyazaki, W. Cornistein, O.A. Trabadelo, F.M. Ross, M. Spotti, G. Funtowicz,
W.E. Scordo, M.H. Losso, I. Ferniot, P.E. Pardo, E. Rodriguez, P. Rucci,
J. Pasquali, N.A. Fuentes, M. Esperatti, G.A. Speroni, E.C. Nannini, A. Matteaccio,
H.G. Michelangelo, D. Follmann, H.C. Lane, and W.H. Belloso,
for the PlasmAr Study Group*
A BS T R AC T
Convalescent plasma is frequently administered to patients with Covid-19 and has
been reported, largely on the basis of observational data, to improve clinical outcomes.
Minimal data are available from adequately powered randomized, controlled trials.
We randomly assigned hospitalized adult patients with severe Covid-19 pneumonia
in a 2:1 ratio to receive convalescent plasma or placebo. The primary outcome was
the patient’s clinical status 30 days after the intervention, as measured on a six-point
ordinal scale ranging from total recovery to death.
A total of 228 patients were assigned to receive convalescent plasma and 105 to
receive placebo. The median time from the onset of symptoms to enrollment in
the trial was 8 days (interquartile range, 5 to 10), and hypoxemia was the most
frequent severity criterion for enrollment. The infused convalescent plasma had a
median titer of 1:3200 of total SARS-CoV-2 antibodies (interquartile range, 1:800 to
1:3200). No patients were lost to follow-up. At day 30 day, no significant difference
was noted between the convalescent plasma group and the placebo group in the
distribution of clinical outcomes according to the ordinal scale (odds ratio, 0.83
(95% confidence interval [CI], 0.52 to 1.35; P = 0.46). Overall mortality was 10.96%
in the convalescent plasma group and 11.43% in the placebo group, for a risk difference of −0.46 percentage points (95% CI, −7.8 to 6.8). Total SARS-CoV-2 antibody
titers tended to be higher in the convalescent plasma group at day 2 after the intervention. Adverse events and serious adverse events were similar in the two groups.
The authors’ full names, academic degrees, and affiliations are listed in the Appendix. Address reprint requests to Dr.
Simonovich at the Clinical Pharmacology
Section, Hospital Italiano de Buenos Aires,
Juan D. Perón 4190 (C1181ACH), Ciudad
Autónoma de Buenos Aires, Argentina,
or at ventura.simonovich@hospitalitaliano
*A complete list of the PlasmAr Study
Group members is provided in the
Supplementary Appendix, available at
This article was published on November
24, 2020, at NEJM.org.
N Engl J Med 2021;384:619-29.
Copyright © 2020 Massachusetts Medical Society.
No significant differences were observed in clinical status or overall mortality between patients treated with convalescent plasma and those who received placebo.
(PlasmAr ClinicalTrials.gov number, NCT04383535.)
n engl j med 384;7
February 18, 2021
The New England Journal of Medicine
Copyright © 2021 Massachusetts Medical Society. All rights reserved.
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