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

Simonovich et al., NEJM, doi:10.1056/NEJMoa2031304, PlasmAr, NCT04383535
Nov 2020  
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Mortality 4% Improvement Relative Risk 7-point scale 19% Conv. Plasma  PlasmAr  LATE TREATMENT  RCT Is late treatment with convalescent plasma beneficial for COVID-19? RCT 333 patients in Argentina (May - August 2020) Improved 7-point scale results with convalescent plasma (not stat. sig., p=0.4) c19early.org Simonovich et al., NEJM, November 2020 Favorsconv. plasma Favorscontrol 0 0.5 1 1.5 2+
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, study period 28 May, 2020 - 27 August, 2020, average treatment delay 8.0 days, trial NCT04383535 (history) (PlasmAr).
This PaperConv. PlasmaAll
A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia
M.D Ventura A Simonovich, M.D Leandro D Burgos Pratx, M.D Paula Scibona, M.D María V Beruto, M.D Marcelo G Vallone, M.D Carolina Vázquez, M.D Nadia Savoy, M.D Diego H Giunta, M..L Lucía G Pérez, M.D Marisa Del L Sánchez, M.D Andrea Vanesa Gamarnik, Ph.D Diego S Ojeda, Ph.D Diego M Santoro, M.D Pablo J Camino, M.D Sebastian Antelo, M.D Karina Rainero, M.D Gabriela P Vidiella, M.D Erica A Miyazaki, M.D Wanda Cornistein, M.D Omar A Trabadelo, M.D Fernando M Ross, M.D Mariano Spotti, Gabriel Funtowicz, M.D Walter E Scordo, M.D Marcelo H Losso, M.D Inés Ferniot, M.D Pablo E Pardo, M.D Eulalia Rodriguez, M.D Pablo Rucci, M.D Julieta Pasquali, M.D Nora A Fuentes, M.D Mariano Esperatti, Ph.D Gerardo A Speroni, M.D Esteban C Nannini, M.D Alejandra Matteaccio, M.D Hernán G Michelangelo, Dean Follmann, Ph.D H Clifford Lane, Waldo H Belloso
New England Journal of Medicine, doi:10.1056/nejmoa2031304
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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' 'Department of Virology, Leloir Institute Foundation, Buenos ' 'Aires (A.V.G., D.S.O.), the Departments of Transfusional ' 'Medicine (K.R.),...'}]}, { 'given': 'Erica A.', 'family': 'Miyazaki', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Clinical Pharmacology Section (V.A.S., P.S., M.V.B., ' 'N.S.), Intermediate Care Unit (M.G.V., C.V., H.G.M.), and ' 'Infectious Diseases Section (M.L.S.), Department of Internal ' 'Medicine, and the Departments of Research (V.A.S., D.H.G., ' 'L.G.P., W.H.B.) and Transfusional Medicine (L.D.B.P., D.M.S., ' 'P.J.C., S.A.), Hospital Italiano de Buenos Aires, Buenos Aires; ' 'Department of Virology, Leloir Institute Foundation, Buenos ' 'Aires (A.V.G., D.S.O.), the Departments of Transfusional ' 'Medicine (K.R.),...'}]}, { 'given': 'Wanda', 'family': 'Cornistein', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Clinical Pharmacology Section (V.A.S., P.S., M.V.B., ' 'N.S.), Intermediate Care Unit (M.G.V., C.V., H.G.M.), and ' 'Infectious Diseases Section (M.L.S.), Department of Internal ' 'Medicine, and the Departments of Research (V.A.S., D.H.G., ' 'L.G.P., W.H.B.) and Transfusional Medicine (L.D.B.P., D.M.S., ' 'P.J.C., S.A.), Hospital Italiano de Buenos Aires, Buenos Aires; ' 'Department of Virology, Leloir Institute Foundation, Buenos ' 'Aires (A.V.G., D.S.O.), the Departments of Transfusional ' 'Medicine (K.R.),...'}]}, { 'given': 'Omar A.', 'family': 'Trabadelo', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Clinical Pharmacology Section (V.A.S., P.S., M.V.B., ' 'N.S.), Intermediate Care Unit (M.G.V., C.V., H.G.M.), and ' 'Infectious Diseases Section (M.L.S.), Department of Internal ' 'Medicine, and the Departments of Research (V.A.S., D.H.G., ' 'L.G.P., W.H.B.) and Transfusional Medicine (L.D.B.P., D.M.S., ' 'P.J.C., S.A.), Hospital Italiano de Buenos Aires, Buenos Aires; ' 'Department of Virology, Leloir Institute Foundation, Buenos ' 'Aires (A.V.G., D.S.O.), the Departments of Transfusional ' 'Medicine (K.R.),...'}]}, { 'given': 'Fernando M.', 'family': 'Ross', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Clinical Pharmacology Section (V.A.S., P.S., M.V.B., ' 'N.S.), Intermediate Care Unit (M.G.V., C.V., H.G.M.), and ' 'Infectious Diseases Section (M.L.S.), Department of Internal ' 'Medicine, and the Departments of Research (V.A.S., D.H.G., ' 'L.G.P., W.H.B.) and Transfusional Medicine (L.D.B.P., D.M.S., ' 'P.J.C., S.A.), Hospital Italiano de Buenos Aires, Buenos Aires; ' 'Department of Virology, Leloir Institute Foundation, Buenos ' 'Aires (A.V.G., D.S.O.), the Departments of Transfusional ' 'Medicine (K.R.),...'}]}, { 'given': 'Mariano', 'family': 'Spotti', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Clinical Pharmacology Section (V.A.S., P.S., M.V.B., ' 'N.S.), Intermediate Care Unit (M.G.V., C.V., H.G.M.), and ' 'Infectious Diseases Section (M.L.S.), Department of Internal ' 'Medicine, and the Departments of Research (V.A.S., D.H.G., ' 'L.G.P., W.H.B.) and Transfusional Medicine (L.D.B.P., D.M.S., ' 'P.J.C., S.A.), Hospital Italiano de Buenos Aires, Buenos Aires; ' 'Department of Virology, Leloir Institute Foundation, Buenos ' 'Aires (A.V.G., D.S.O.), the Departments of Transfusional ' 'Medicine (K.R.),...'}]}, { 'given': 'Gabriel', 'family': 'Funtowicz', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Clinical Pharmacology Section (V.A.S., P.S., M.V.B., ' 'N.S.), Intermediate Care Unit (M.G.V., C.V., H.G.M.), and ' 'Infectious Diseases Section (M.L.S.), Department of Internal ' 'Medicine, and the Departments of Research (V.A.S., D.H.G., ' 'L.G.P., W.H.B.) and Transfusional Medicine (L.D.B.P., D.M.S., ' 'P.J.C., S.A.), Hospital Italiano de Buenos Aires, Buenos Aires; ' 'Department of Virology, Leloir Institute Foundation, Buenos ' 'Aires (A.V.G., D.S.O.), the Departments of Transfusional ' 'Medicine (K.R.),...'}]}, { 'given': 'Walter E.', 'family': 'Scordo', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Clinical Pharmacology Section (V.A.S., P.S., M.V.B., ' 'N.S.), Intermediate Care Unit (M.G.V., C.V., H.G.M.), and ' 'Infectious Diseases Section (M.L.S.), Department of Internal ' 'Medicine, and the Departments of Research (V.A.S., D.H.G., ' 'L.G.P., W.H.B.) and Transfusional Medicine (L.D.B.P., D.M.S., ' 'P.J.C., S.A.), Hospital Italiano de Buenos Aires, Buenos Aires; ' 'Department of Virology, Leloir Institute Foundation, Buenos ' 'Aires (A.V.G., D.S.O.), the Departments of Transfusional ' 'Medicine (K.R.),...'}]}, { 'given': 'Marcelo H.', 'family': 'Losso', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Clinical Pharmacology Section (V.A.S., P.S., M.V.B., ' 'N.S.), Intermediate Care Unit (M.G.V., C.V., H.G.M.), and ' 'Infectious Diseases Section (M.L.S.), Department of Internal ' 'Medicine, and the Departments of Research (V.A.S., D.H.G., ' 'L.G.P., W.H.B.) and Transfusional Medicine (L.D.B.P., D.M.S., ' 'P.J.C., S.A.), Hospital Italiano de Buenos Aires, Buenos Aires; ' 'Department of Virology, Leloir Institute Foundation, Buenos ' 'Aires (A.V.G., D.S.O.), the Departments of Transfusional ' 'Medicine (K.R.),...'}]}, { 'given': 'Inés', 'family': 'Ferniot', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Clinical Pharmacology Section (V.A.S., P.S., M.V.B., ' 'N.S.), Intermediate Care Unit (M.G.V., C.V., H.G.M.), and ' 'Infectious Diseases Section (M.L.S.), Department of Internal ' 'Medicine, and the Departments of Research (V.A.S., D.H.G., ' 'L.G.P., W.H.B.) and Transfusional Medicine (L.D.B.P., D.M.S., ' 'P.J.C., S.A.), Hospital Italiano de Buenos Aires, Buenos Aires; ' 'Department of Virology, Leloir Institute Foundation, Buenos ' 'Aires (A.V.G., D.S.O.), the Departments of Transfusional ' 'Medicine (K.R.),...'}]}, { 'given': 'Pablo E.', 'family': 'Pardo', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Clinical Pharmacology Section (V.A.S., P.S., M.V.B., ' 'N.S.), Intermediate Care Unit (M.G.V., C.V., H.G.M.), and ' 'Infectious Diseases Section (M.L.S.), Department of Internal ' 'Medicine, and the Departments of Research (V.A.S., D.H.G., ' 'L.G.P., W.H.B.) and Transfusional Medicine (L.D.B.P., D.M.S., ' 'P.J.C., S.A.), Hospital Italiano de Buenos Aires, Buenos Aires; ' 'Department of Virology, Leloir Institute Foundation, Buenos ' 'Aires (A.V.G., D.S.O.), the Departments of Transfusional ' 'Medicine (K.R.),...'}]}, { 'given': 'Eulalia', 'family': 'Rodriguez', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Clinical Pharmacology Section (V.A.S., P.S., M.V.B., ' 'N.S.), Intermediate Care Unit (M.G.V., C.V., H.G.M.), and ' 'Infectious Diseases Section (M.L.S.), Department of Internal ' 'Medicine, and the Departments of Research (V.A.S., D.H.G., ' 'L.G.P., W.H.B.) and Transfusional Medicine (L.D.B.P., D.M.S., ' 'P.J.C., S.A.), Hospital Italiano de Buenos Aires, Buenos Aires; ' 'Department of Virology, Leloir Institute Foundation, Buenos ' 'Aires (A.V.G., D.S.O.), the Departments of Transfusional ' 'Medicine (K.R.),...'}]}, { 'given': 'Pablo', 'family': 'Rucci', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Clinical Pharmacology Section (V.A.S., P.S., M.V.B., ' 'N.S.), Intermediate Care Unit (M.G.V., C.V., H.G.M.), and ' 'Infectious Diseases Section (M.L.S.), Department of Internal ' 'Medicine, and the Departments of Research (V.A.S., D.H.G., ' 'L.G.P., W.H.B.) and Transfusional Medicine (L.D.B.P., D.M.S., ' 'P.J.C., S.A.), Hospital Italiano de Buenos Aires, Buenos Aires; ' 'Department of Virology, Leloir Institute Foundation, Buenos ' 'Aires (A.V.G., D.S.O.), the Departments of Transfusional ' 'Medicine (K.R.),...'}]}, { 'given': 'Julieta', 'family': 'Pasquali', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Clinical Pharmacology Section (V.A.S., P.S., M.V.B., ' 'N.S.), Intermediate Care Unit (M.G.V., C.V., H.G.M.), and ' 'Infectious Diseases Section (M.L.S.), Department of Internal ' 'Medicine, and the Departments of Research (V.A.S., D.H.G., ' 'L.G.P., W.H.B.) and Transfusional Medicine (L.D.B.P., D.M.S., ' 'P.J.C., S.A.), Hospital Italiano de Buenos Aires, Buenos Aires; ' 'Department of Virology, Leloir Institute Foundation, Buenos ' 'Aires (A.V.G., D.S.O.), the Departments of Transfusional ' 'Medicine (K.R.),...'}]}, { 'ORCID': 'http://orcid.org/0000-0002-4893-3374', 'authenticated-orcid': False, 'given': 'Nora A.', 'family': 'Fuentes', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Clinical Pharmacology Section (V.A.S., P.S., M.V.B., ' 'N.S.), Intermediate Care Unit (M.G.V., C.V., H.G.M.), and ' 'Infectious Diseases Section (M.L.S.), Department of Internal ' 'Medicine, and the Departments of Research (V.A.S., D.H.G., ' 'L.G.P., W.H.B.) and Transfusional Medicine (L.D.B.P., D.M.S., ' 'P.J.C., S.A.), Hospital Italiano de Buenos Aires, Buenos Aires; ' 'Department of Virology, Leloir Institute Foundation, Buenos ' 'Aires (A.V.G., D.S.O.), the Departments of Transfusional ' 'Medicine (K.R.),...'}]}, { 'given': 'Mariano', 'family': 'Esperatti', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Clinical Pharmacology Section (V.A.S., P.S., M.V.B., ' 'N.S.), Intermediate Care Unit (M.G.V., C.V., H.G.M.), and ' 'Infectious Diseases Section (M.L.S.), Department of Internal ' 'Medicine, and the Departments of Research (V.A.S., D.H.G., ' 'L.G.P., W.H.B.) and Transfusional Medicine (L.D.B.P., D.M.S., ' 'P.J.C., S.A.), Hospital Italiano de Buenos Aires, Buenos Aires; ' 'Department of Virology, Leloir Institute Foundation, Buenos ' 'Aires (A.V.G., D.S.O.), the Departments of Transfusional ' 'Medicine (K.R.),...'}]}, { 'given': 'Gerardo A.', 'family': 'Speroni', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Clinical Pharmacology Section (V.A.S., P.S., M.V.B., ' 'N.S.), Intermediate Care Unit (M.G.V., C.V., H.G.M.), and ' 'Infectious Diseases Section (M.L.S.), Department of Internal ' 'Medicine, and the Departments of Research (V.A.S., D.H.G., ' 'L.G.P., W.H.B.) and Transfusional Medicine (L.D.B.P., D.M.S., ' 'P.J.C., S.A.), Hospital Italiano de Buenos Aires, Buenos Aires; ' 'Department of Virology, Leloir Institute Foundation, Buenos ' 'Aires (A.V.G., D.S.O.), the Departments of Transfusional ' 'Medicine (K.R.),...'}]}, { 'given': 'Esteban C.', 'family': 'Nannini', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Clinical Pharmacology Section (V.A.S., P.S., M.V.B., ' 'N.S.), Intermediate Care Unit (M.G.V., C.V., H.G.M.), and ' 'Infectious Diseases Section (M.L.S.), Department of Internal ' 'Medicine, and the Departments of Research (V.A.S., D.H.G., ' 'L.G.P., W.H.B.) and Transfusional Medicine (L.D.B.P., D.M.S., ' 'P.J.C., S.A.), Hospital Italiano de Buenos Aires, Buenos Aires; ' 'Department of Virology, Leloir Institute Foundation, Buenos ' 'Aires (A.V.G., D.S.O.), the Departments of Transfusional ' 'Medicine (K.R.),...'}]}, { 'given': 'Alejandra', 'family': 'Matteaccio', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Clinical Pharmacology Section (V.A.S., P.S., M.V.B., ' 'N.S.), Intermediate Care Unit (M.G.V., C.V., H.G.M.), and ' 'Infectious Diseases Section (M.L.S.), Department of Internal ' 'Medicine, and the Departments of Research (V.A.S., D.H.G., ' 'L.G.P., W.H.B.) and Transfusional Medicine (L.D.B.P., D.M.S., ' 'P.J.C., S.A.), Hospital Italiano de Buenos Aires, Buenos Aires; ' 'Department of Virology, Leloir Institute Foundation, Buenos ' 'Aires (A.V.G., D.S.O.), the Departments of Transfusional ' 'Medicine (K.R.),...'}]}, { 'given': 'Hernán G.', 'family': 'Michelangelo', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Clinical Pharmacology Section (V.A.S., P.S., M.V.B., ' 'N.S.), Intermediate Care Unit (M.G.V., C.V., H.G.M.), and ' 'Infectious Diseases Section (M.L.S.), Department of Internal ' 'Medicine, and the Departments of Research (V.A.S., D.H.G., ' 'L.G.P., W.H.B.) and Transfusional Medicine (L.D.B.P., D.M.S., ' 'P.J.C., S.A.), Hospital Italiano de Buenos Aires, Buenos Aires; ' 'Department of Virology, Leloir Institute Foundation, Buenos ' 'Aires (A.V.G., D.S.O.), the Departments of Transfusional ' 'Medicine (K.R.),...'}]}, { 'given': 'Dean', 'family': 'Follmann', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Clinical Pharmacology Section (V.A.S., P.S., M.V.B., ' 'N.S.), Intermediate Care Unit (M.G.V., C.V., H.G.M.), and ' 'Infectious Diseases Section (M.L.S.), Department of Internal ' 'Medicine, and the Departments of Research (V.A.S., D.H.G., ' 'L.G.P., W.H.B.) and Transfusional Medicine (L.D.B.P., D.M.S., ' 'P.J.C., S.A.), Hospital Italiano de Buenos Aires, Buenos Aires; 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Late treatment
is less effective
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