RESUMO
BACKGROUNDAlthough convalescent plasma has been widely used to treat severe coronavirus disease 2019 (COVID-19), data from randomized controlled trials that support its efficacy are limited.METHODSWe conducted a randomized, double-blind, controlled trial among adults hospitalized with severe and critical COVID-19 at 5 sites in New York City (USA) and Rio de Janeiro (Brazil). Patients were randomized 2:1 to receive a single transfusion of either convalescent plasma or normal control plasma. The primary outcome was clinical status at 28 days following randomization, measured using an ordinal scale and analyzed using a proportional odds model in the intention-to-treat population.RESULTSOf 223 participants enrolled, 150 were randomized to receive convalescent plasma and 73 to receive normal control plasma. At 28 days, no significant improvement in the clinical scale was observed in participants randomized to convalescent plasma (OR 1.50, 95% confidence interval [CI] 0.83-2.68, P = 0.180). However, 28-day mortality was significantly lower in participants randomized to convalescent plasma versus control plasma (19/150 [12.6%] versus 18/73 [24.6%], OR 0.44, 95% CI 0.22-0.91, P = 0.034). The median titer of anti-SARS-CoV-2 neutralizing antibody in infused convalescent plasma units was 1:160 (IQR 1:80-1:320). In a subset of nasopharyngeal swab samples from Brazil that underwent genomic sequencing, no evidence of neutralization-escape mutants was detected.CONCLUSIONIn adults hospitalized with severe COVID-19, use of convalescent plasma was not associated with significant improvement in day 28 clinical status. However, convalescent plasma was associated with significantly improved survival. A possible explanation is that survivors remained hospitalized at their baseline clinical status.TRIAL REGISTRATIONClinicalTrials.gov, NCT04359810.FUNDINGAmazon Foundation, Skoll Foundation.
Assuntos
COVID-19/terapia , SARS-CoV-2 , Adulto , Idoso , Idoso de 80 Anos ou mais , Brasil/epidemiologia , COVID-19/imunologia , COVID-19/mortalidade , Método Duplo-Cego , Feminino , Humanos , Imunização Passiva , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Cidade de Nova Iorque/epidemiologia , Pandemias , SARS-CoV-2/imunologia , Índice de Gravidade de Doença , Resultado do Tratamento , Soroterapia para COVID-19RESUMO
ECMO (Extracorporeal Membrane Oxygenation) is an extracorporeal life support system in catastrophic lung failure, shock and cardiopulmonary resuscitation, in different age groups, with multiple physiologic features. When the candidate to be submitted is too unstable to be transported to a hospital with ECMO, cannulation before transfer allows stabilization and subsequent transport. The aim of this article is to review the current concepts of extracorporeal support, its indications, national and international experience, and its possible role in the SARS-Cov2 pandemic.
Assuntos
Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Oxigenação por Membrana Extracorpórea , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Adulto , COVID-19 , Humanos , PandemiasRESUMO
ECMO (Extracorporeal Membrane Oxygenation) is an extracorporeal life support system in catastrophic lung failure, shock and cardiopulmonary resuscitation, in different age groups, with multiple physiologic features. When the candidate to be submitted is too unstable to be transported to a hospital with ECMO, cannulation before transfer allows stabilization and subsequent transport. The aim of this article is to review the current concepts of extracorporeal support, its indications, national and international experience, and its possible role in the SARS-Cov2 pandemic.