1. A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia
- Author
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Pablo J. Camino, Fernando M. Ross, Sebastian Antelo, Pablo Rucci, Eulalia Rodriguez, Alejandra Matteaccio, N. Savoy, Waldo H. Belloso, Lucia Perez, Gabriela Vidiella, Maria Valeria Beruto, Leandro Burgos Pratx, Dean Follmann, Nora Fuentes, Gerardo A. Speroni, Ventura A Simonovich, Wanda Cornistein, Gabriel Funtowicz, Karina Rainero, Erica A. Miyazaki, Marcelo Vallone, Mariano Esperatti, Diego Mario Santoro, Diego Giunta, H. Clifford Lane, Diego Sebastian Ojeda, Omar A. Trabadelo, Walter E. Scordo, Marisa Sanchez, Pablo E. Pardo, Paula Scibona, Inés Ferniot, Hernán G. Michelangelo, Carolina Vázquez, Marcelo H. Losso, Julieta Pasquali, Esteban C. Nannini, Mariano Spotti, and Andrea V. Gamarnik
- Subjects
Male ,medicine.medical_specialty ,CIENCIAS MÉDICAS Y DE LA SALUD ,Pneumonia, Viral ,Blood Component Transfusion ,Kaplan-Meier Estimate ,SARS-COV-2 ,Medicina Clínica ,030204 cardiovascular system & hematology ,Placebo ,Severity of Illness Index ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Double-Blind Method ,Interquartile range ,law ,Internal medicine ,purl.org/becyt/ford/3.2 [https] ,Severity of illness ,medicine ,Humans ,Medicina General e Interna ,030212 general & internal medicine ,Adverse effect ,COVID-19 Serotherapy ,Aged ,Aged, 80 and over ,PLASMA ,business.industry ,SARS-CoV-2 ,Absolute risk reduction ,Immunization, Passive ,COVID-19 ,General Medicine ,Odds ratio ,CONVALECIENTE ,Middle Aged ,Antibodies, Neutralizing ,Confidence interval ,Hospitalization ,Immunoglobulin G ,Disease Progression ,purl.org/becyt/ford/3 [https] ,Original Article ,Female ,business - Abstract
BACKGROUND:Convalescent plasma is frequently administered to patients with Covid-19 and hasbeen 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 pneumoniain a 2:1 ratio to receive convalescent plasma or placebo. The primary outcome wasthe patient?s clinical status 30 days after the intervention, as measured on a six-pointordinal scale ranging from total recovery to death. RESULTS:A total of 228 patients were assigned to receive convalescent plasma and 105 toreceive placebo. The median time from the onset of symptoms to enrollment inthe trial was 8 days (interquartile range, 5 to 10), and hypoxemia was the mostfrequent severity criterion for enrollment. The infused convalescent plasma had amedian titer of 1:3200 of total SARS-CoV-2 antibodies (interquartile range, 1:800 to1:3200]. No patients were lost to follow-up. At day 30 day, no significant differencewas noted between the convalescent plasma group and the placebo group in thedistribution 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 antibodytiters 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.) Fil: Simonovich, Ventura A.. Hospital Italiano. Departamento de Medicina. Servicio de Clinica Medica.; Argentina Fil: Burgos Pratx, Leandro D.. Hospital Italiano. Departamento de Medicina. Servicio de Clinica Medica.; Argentina Fil: Scibona, Paula. Hospital Italiano. Departamento de Medicina. Servicio de Clinica Medica.; Argentina Fil: Beruto, Maria Valeria. No especifíca; Fil: Vallone, Miguel Gabriel. No especifíca; Fil: Vázquez, C.. No especifíca; Fil: Savoy, N.. No especifíca; Fil: Giunta, Diego Hernan. No especifíca; Fil: Pérez, L.G.. No especifíca; Fil: Sánchez, M.L.. No especifíca; Fil: Gamarnik, Andrea Vanesa. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Instituto de Investigaciones Bioquímicas de Buenos Aires. Fundación Instituto Leloir. Instituto de Investigaciones Bioquímicas de Buenos Aires; Argentina Fil: Ojeda, D.S.. No especifíca; Fil: Santoro, D.M.. No especifíca; Fil: Camino, P. J.. No especifíca; Fil: Antelo, S.. No especifíca; Fil: Rainero, K.. No especifíca; Fil: Vidiella, G. P.. No especifíca; Fil: Miyazaki, E. A.. No especifíca; Fil: Cornistein, W.. No especifíca; Fil: Trabadelo, O. A.. No especifíca; Fil: Ross, F. M.. No especifíca; Fil: Spotti, M.. No especifíca; Fil: Funtowicz, G.. No especifíca; Fil: Scordo, W. E.. No especifíca; Fil: Losso, M. H.. No especifíca; Fil: Ferniot, I.. No especifíca; Fil: Pardo, P. E.. No especifíca; Fil: Rodriguez, E.. No especifíca; Fil: Rucci, P.. No especifíca; Fil: Pasquali, J.. No especifíca; Fil: Fuentes, N. A.. No especifíca; Fil: Esperatti, M.. No especifíca; Fil: Speroni, G. A.. No especifíca; Fil: Nannini, Esteban. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Inmunología Clinica y Experimental de Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Médicas. Instituto de Inmunología Clinica y Experimental de Rosario; Argentina Fil: Matteaccio, A.. No especifíca; Fil: Michelangelo, H.G.. No especifíca; Fil: Follmann, D.. No especifíca; Fil: Lane, H. Clifford. No especifíca; Fil: Belloso, Waldo Horacio. Hospital Italiano. Departamento de Medicina. Servicio de Clinica Medica.; Argentina
- Published
- 2020
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