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A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia.
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.
  • Simonovich VA; 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.
  • Burgos Pratx LD; 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.
  • Scibona P; 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.
  • Beruto MV; 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.
  • Vallone MG; 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.
  • Vázquez C; 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.
  • Savoy N; 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.
  • Giunta DH; 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.
  • Pérez LG; 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.
  • Sánchez MDL; 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.
  • Gamarnik AV; 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.
  • Ojeda DS; 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.
  • Santoro DM; 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.
  • Camino PJ; 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.
  • Antelo S; 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.
  • Rainero K; 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.
  • Vidiella GP; 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.
  • Miyazaki EA; 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.
  • Cornistein W; 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.
  • Trabadelo OA; 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.
  • Ross FM; 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.
  • Spotti M; 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.
  • Funtowicz G; 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.
  • Scordo WE; 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.
  • Losso MH; 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.
  • Ferniot I; 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.
  • Pardo PE; 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.
  • Rodriguez E; 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.
  • Rucci P; 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.
  • Pasquali J; 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.
  • Fuentes NA; 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.
  • Esperatti M; 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.
  • Speroni GA; 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.
  • Nannini EC; 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.
  • Matteaccio A; 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.
  • Michelangelo HG; 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.
  • Follmann D; 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.
  • Lane HC; 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.
  • Belloso WH; 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.
N Engl J Med ; 384(7): 619-629, 2021 02 18.
Article in English | MEDLINE | ID: covidwho-990095
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 21 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 13200 of total SARS-CoV-2 antibodies (interquartile range, 1800 to 13200). 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.).
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Immunoglobulin G / Antibodies, Neutralizing / SARS-CoV-2 / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Aged / Female / Humans / Male / Middle aged Language: English Journal: N Engl J Med Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Immunoglobulin G / Antibodies, Neutralizing / SARS-CoV-2 / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Aged / Female / Humans / Male / Middle aged Language: English Journal: N Engl J Med Year: 2021 Document Type: Article