Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
Department of Epidemiology, and.
J Clin Invest. 2021 Jul 1;131(13). doi: 10.1172/JCI150646.
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.
尽管恢复期血浆已被广泛用于治疗严重的 2019 年冠状病毒病（COVID-19），但支持其疗效的随机对照试验数据有限。
我们在纽约市（美国）和里约热内卢（巴西）的 5 个地点对患有严重和危重症 COVID-19 的成年住院患者进行了一项随机、双盲、对照试验。患者按 2:1 的比例随机接受恢复期血浆或正常对照血浆的单次输注。主要结局是随机分组后 28 天的临床状态，采用序贯量表进行测量，并在意向治疗人群中使用比例优势模型进行分析。
在纳入的 223 名患者中，150 名被随机分配接受恢复期血浆治疗，73 名接受正常对照血浆治疗。在 28 天时，接受恢复期血浆治疗的患者的临床量表没有显著改善（OR 1.50，95%置信区间[CI]0.83-2.68，P=0.180）。然而，与接受对照血浆治疗的患者相比，接受恢复期血浆治疗的患者 28 天死亡率显著降低（150 名中的 19 名[12.6%]与 73 名中的 18 名[24.6%]，OR 0.44，95%CI 0.22-0.91，P=0.034）。输注的恢复期血浆单位中抗 SARS-CoV-2 中和抗体的中位数滴度为 1:160（IQR 1:80-1:320）。在巴西进行基因组测序的部分鼻咽拭子样本中，未发现中和逃逸突变体的证据。
在因严重 COVID-19 住院的成年人中，使用恢复期血浆与第 28 天临床状态的显著改善无关。然而，恢复期血浆与显著改善的生存率相关。一种可能的解释是，幸存者仍以其基线临床状态留在医院。
ClinicalTrials.gov，NCT04359810。
亚马逊基金会，斯库尔基金会。
