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0 0.5 1 1.5 2+ Mortality 50% Improvement Relative Risk Ventilation 50% ICU admission 67% Progression 48% c19early.org/cp Libster et al. NCT04479163 INFANT-COVID-19 Conv. Plasma RCT EARLY Is early treatment with convalescent plasma beneficial for COVID-19? Double-blind RCT 160 patients in Argentina Lower progression with convalescent plasma (p=0.029) Libster et al., NEJM, doi:10.1056/NEJMoa2033700 Favors conv. plasma Favors control
Early High-Titer Plasma Therapy to Prevent Severe Covid-19 in Older Adults
Libster et al., NEJM, doi:10.1056/NEJMoa2033700, INFANT-COVID-19, NCT04479163 (history)
Libster et al., Early High-Titer Plasma Therapy to Prevent Severe Covid-19 in Older Adults, NEJM, doi:10.1056/NEJMoa2033700, INFANT-COVID-19, NCT04479163
Jan 2021   Source   PDF  
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RCT 160 patients >=65 with symptom onset <72 hours, 80 treated with convalescent plasma, showing lower progression to severe disease with treatment.
risk of death, 50.0% lower, RR 0.50, p = 0.43, treatment 2 of 80 (2.5%), control 4 of 80 (5.0%), NNT 40.
risk of mechanical ventilation, 50.0% lower, RR 0.50, p = 0.43, treatment 2 of 80 (2.5%), control 4 of 80 (5.0%), NNT 40.
risk of ICU admission, 67.0% lower, RR 0.33, p = 0.17, treatment 2 of 80 (2.5%), control 6 of 80 (7.5%), NNT 20.
risk of progression, 48.0% lower, RR 0.52, p = 0.03, treatment 13 of 80 (16.2%), control 25 of 80 (31.2%), NNT 6.7.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Libster et al., 6 Jan 2021, Double Blind Randomized Controlled Trial, Argentina, peer-reviewed, 56 authors, trial NCT04479163 (history) (INFANT-COVID-19).
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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 Early High-Titer Plasma Therapy to Prevent Severe Covid-19 in Older Adults R. Libster, G. Pérez Marc, D. Wappner, S. Coviello, A. Bianchi, V. Braem, I. Esteban, M.T. Caballero, C. Wood, M. Berrueta, A. Rondan, G. Lescano, P. Cruz, Y. Ritou, V. Fernández Viña, D. Álvarez Paggi, S. Esperante, A. Ferreti, G. Ofman, Á. Ciganda, R. Rodriguez, J. Lantos, R. Valentini, N. Itcovici, A. Hintze, M.L. Oyarvide, C. Etchegaray, A. Neira, I. Name, J. Alfonso, R. López Castelo, G. Caruso, S. Rapelius, F. Alvez, F. Etchenique, F. Dimase, D. Alvarez, S.S. Aranda, C. Sánchez Yanotti, J. De Luca, S. Jares Baglivo, S. Laudanno, F. Nowogrodzki, R. Larrea, M. Silveyra, G. Leberzstein, A. Debonis, J. Molinos, M. González, E. Perez, N. Kreplak, S. Pastor Argüello, L. Gibbons, F. Althabe, E. Bergel, and F.P. Polack, for the Fundación INFANT–COVID-19 Group*​​ A BS T R AC T BACKGROUND The authors’ full names, academic degrees, and affiliations are listed in the Appendix. Address reprint requests to Dr. Polack at Fundación INFANT, Gavilan 94, Buenos Aires (1406), Argentina, or at ­fpolack@​­infant​.­org​.­ar. Therapies to interrupt the progression of early coronavirus disease 2019 (Covid-19) remain elusive. Among them, convalescent plasma administered to hospitalized patients has been unsuccessful, perhaps because antibodies should be administered earlier in the course of illness. *The Fundación INFANT–COVID-19 Group members are listed in the Supplementary Appendix, available with the full text of this article at NEJM.org. We conducted a randomized, double-blind, placebo-controlled trial of convalescent plasma with high IgG titers against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in older adult patients within 72 hours after the onset of mild Covid-19 symptoms. The primary end point was severe respiratory disease, defined as a respiratory rate of 30 breaths per minute or more, an oxygen saturation of less than 93% while the patient was breathing ambient air, or both. The trial was stopped early at 76% of its projected sample size because cases of Covid-19 in the trial region decreased considerably and steady enrollment of trial patients became virtually impossible. Drs. Libster and Pérez Marc contributed equally to this article. This is the New England Journal of Medicine version of record, which includes all Journal editing and enhancements. The Author Final Manuscript, which is the author’s version after external peer review and before publication in the Journal, is available under a CC BY license at PMC7793608. This article was published on January 6, 2021, at NEJM.org. N Engl J Med 2021;384:610-8. DOI: 10.1056/NEJMoa2033700 Copyright © 2021 Massachusetts Medical Society. METHODS RESULTS A total of 160 patients underwent randomization. In the intention-to-treat population, severe respiratory disease developed in 13 of 80 patients (16%) who received convalescent plasma and 25 of 80 patients (31%) who received placebo (relative risk, 0.52; 95% confidence interval [CI], 0.29 to 0.94; P = 0.03), with a relative risk reduction of 48%. A modified intention-to-treat analysis that excluded 6 patients who had a primary end-point event before infusion of convalescent plasma or placebo showed a larger effect size (relative risk, 0.40; 95% CI, 0.20 to 0.81). No solicited adverse events were observed. CONCLUSIONS Early administration of high-titer convalescent plasma..
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