Early safety indicators of COVID-19 convalescent plasma in 5000 patients
Early safety indicators of COVID-19 convalescent plasma in 5000 patients
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DOI：
10.1101/2020.05.12.20099879
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发表时间：
2020-09-01
影响因子：
15.9
通讯作者：
Casadevall, Arturo
中科院分区：
文献类型：
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作者：
Joyner, Michael J.;Wright, R. Scott;Casadevall, Arturo
背景恢复期血浆是目前唯一可用于2019冠状病毒病（COVID-19）患者的基于抗体的疗法。它具有强大的历史优先性和良好的生物相容性。虽然有希望，但恢复期血浆尚未被证明是安全的COVID-19治疗方法。因此，我们分析了在5000名患有严重或危及生命的COVID-19的住院成人中输注ABO相容的人COVID-19恢复期血浆后的关键安全性指标，其中66%在重症监护室，作为美国FDA扩大COVID-19恢复期血浆获取计划的一部分。输血后前4小时内所有严重不良事件（SAE）的发生率，包括死亡率（0.3%），
BACKGROUND. Convalescent plasma is the only antibody-based therapy currently available for patients with coronavirus disease 2019 (COVID-19). It has robust historical precedence and sound biological plausibility. Although promising, convalescent plasma has not yet been shown to be safe as a treatment for COVID-19.METHODS. Thus, we analyzed key safety metrics after transfusion of ABO-compatible human COVID-19 convalescent plasma in 5000 hospitalized adults with severe or life-threatening COVID-19, with 66% in the intensive care unit, as part of the US FDA expanded access program for COVID-19 convalescent plasma.RESULTS. The incidence of all serious adverse events (SAEs), including mortality rate (0.3%), in the first 4 hours after transfusion was