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A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia

Open access
Simonovich, Ventura A., Burgos Pratx, Leandro D., Scibona, Paula, Beruto, María V., Vallone, Marcelo G., Vázquez, Carolina, Savoy, Nadia, Giunta, Diego H., Pérez, Lucía G., Sánchez, Marisa del L., Gamarnik, Andrea Vanesa, Ojeda, Diego S., Santoro, Diego M., Camino, Pablo J., Antelo, Sebastian, Rainero, Karina, Vidiella, Gabriela P., Miyazaki, Erica A., Cornistein, Wanda, Trabadelo, Omar A., Ross, Fernando M., Spotti, Mariano, Funtowicz, Gabriel, Scordo, Walter E., Losso, Marcelo H., Ferniot, Inés, Pardo, Pablo E., Rodriguez, Eulalia, Rucci, Pablo, Pasquali, Julieta, Fuentes, Nora A., Esperatti, Mariano, Speroni, Gerardo A., Nannini, Esteban C., Matteaccio, Alejandra, Michelangelo, Hernán G., Follmann, Dean, Lane, H. Clifford, Belloso, Waldo H.·2021·New England Journal of Medicine

Abstract

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. 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.).

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Metadata

Authors
Simonovich, V. A., Burgos Pratx, L. D., Scibona, P., Beruto, M. V., Vallone, M. G., Vázquez, C., Savoy, N., Giunta, D. H., Pérez, L. G., Sánchez, M. D. L., Gamarnik, A. V., Ojeda, D. S., Santoro, D. M., Camino, P. J., Antelo, S., Rainero, K., Vidiella, G. P., Miyazaki, E. A., Cornistein, W., Trabadelo, O. A., Ross, F. M., Spotti, M., Funtowicz, G., Scordo, W. E., Losso, M. H., Ferniot, I., Pardo, P. E., Rodriguez, E., Rucci, P., Pasquali, J., Fuentes, N. A., Esperatti, M., Speroni, G. A., Nannini, E. C., Matteaccio, A., Michelangelo, H. G., Follmann, D., Lane, H. C., & Belloso, W. H.
Venue
New England Journal of Medicine
Published
2021-02-18
Volume
384
Issue
7
Pages
619-629
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W3110542218
Cited by
907
References
21
FWCI
25.71
Type
journal article
Language
en
Open access
green

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CoChat. (2026). Citation check: A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia. https://app.cochat.ai/papers/10.1056/nejmoa2031304
The paper
Simonovich, V. A., Burgos Pratx, L. D., Scibona, P., Beruto, M. V., Vallone, M. G., Vázquez, C., Savoy, N., Giunta, D. H., Pérez, L. G., Sánchez, M. D. L., Gamarnik, A. V., Ojeda, D. S., Santoro, D. M., Camino, P. J., Antelo, S., Rainero, K., Vidiella, G. P., Miyazaki, E. A., Cornistein, W., . . . Belloso, W. H. (2021). A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2031304

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.