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0 0.5 1 1.5 2+ Mortality 4% Improvement Relative Risk 7-point scale 19% c19early.org/cp Simonovich et al. NCT04383535 PlasmAr Conv. Plasma RCT LATE Is late treatment with convalescent plasma beneficial for COVID-19? RCT 333 patients in Argentina Improved 7-point scale results with convalescent plasma (not stat. sig., p=0.4) Simonovich et al., NEJM, doi:0.1056/NEJMoa2031304 Favors conv. plasma Favors control
A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia
Simonovich et al., NEJM, doi:0.1056/NEJMoa2031304, PlasmAr, NCT04383535 (history)
Simonovich et al., A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia, NEJM, doi:0.1056/NEJMoa2031304, PlasmAr, NCT04383535
Nov 2020   Source   PDF  
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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) (PlasmAr).
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Abstract: The n e w e ng l a n d j o u r na l of m e dic i n e Original Article 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 BACKGROUND 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. METHODS 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. RESULTS 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​ .­org​.­ar. *A complete list of the PlasmAr Study Group members is provided in the Supplementary Appendix, available at NEJM.org. This article was published on November 24, 2020, at NEJM.org. N Engl J Med 2021;384:619-29. DOI: 10.1056/NEJMoa2031304 Copyright © 2020 Massachusetts Medical Society. CONCLUSIONS 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 nejm.org February 18, 2021 The New England Journal of Medicine Copyright © 2021 Massachusetts Medical Society. All rights reserved. 619 The n e w e..
Late treatment
is less effective
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