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

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