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• W3136300912 abstract "Abstract Background Although 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. Objective To evaluate the clinical efficacy and safety of convalescent plasma among adults hospitalized with severe and critical COVID-19. Design Randomized, double-blind, controlled, multicenter, phase 2 trial conducted from April 21 st to November 27 th , 2020. Setting Five hospitals in New York City (NY, USA) and Rio de Janeiro (Brazil). Participants Hospitalized patients aged ≥18 years with laboratory-confirmed COVID-19, infiltrates on chest imaging and oxygen saturation ≤ 94% on room air or requirement for supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. Intervention Participants were randomized 2:1 to a single transfusion of either 1 unit of convalescent or normal control plasma. Measurements The primary outcome was clinical status at 28 days, measured using an ordinal scale and analyzed using a proportional odds model in the intention-to-treat population. Results Of 223 participants enrolled, 150 were randomized to receive convalescent plasma and 73 to normal control plasma. At 28 days, no significant improvement in clinical status was observed in participants randomized to convalescent plasma (with an odds ratio (OR) of a 1-point improvement in the scale: 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 (n=40) from Brazil that underwent genomic sequencing, no evidence of neutralization-escape mutants was detected. Serious adverse events occurred in 39/147 (27%) participants who received convalescent plasma and 26/72 (36%) participants who received control plasma. Limitations Some participants did not receive high-titer convalescent plasma. Conclusion In adults hospitalized with severe COVID-19, use of convalescent plasma was not associated with significant improvement in 28 days clinical status. The significant reduction in mortality associated with convalescent plasma, however, may warrant further evaluation. Registration ClinicalTrials.gov, NCT04359810 Funding Amazon Foundation Clinical Trial Registration ClinicalTrials.gov Identifier: NCT04359810" @default.
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• W3136300912 date "2021-03-13" @default.
• W3136300912 modified "2023-10-16" @default.
• W3136300912 title "A randomized, double-blind, controlled trial of convalescent plasma in adults with severe COVID-19" @default.
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• W3136300912 doi "https://doi.org/10.1101/2021.03.12.21253373" @default.
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