Division of Transfusion Medicine, Department of Pathology.
Department of Infectious Diseases, School of Medicine, and.
J Clin Invest. 2020 Jun 1;130(6):2757-2765. doi: 10.1172/JCI138745.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19), has spurred a global health crisis. To date, there are no proven options for prophylaxis for those who have been exposed to SARS-CoV-2, nor therapy for those who develop COVID-19. Immune (i.e., "convalescent") plasma refers to plasma that is collected from individuals following resolution of infection and development of antibodies. Passive antibody administration through transfusion of convalescent plasma may offer the only short-term strategy for conferring immediate immunity to susceptible individuals. There are numerous examples in which convalescent plasma has been used successfully as postexposure prophylaxis and/or treatment of infectious diseases, including other outbreaks of coronaviruses (e.g., SARS-1, Middle East respiratory syndrome [MERS]). Convalescent plasma has also been used in the COVID-19 pandemic; limited data from China suggest clinical benefit, including radiological resolution, reduction in viral loads, and improved survival. Globally, blood centers have robust infrastructure for undertaking collections and constructing inventories of convalescent plasma to meet the growing demand. Nonetheless, there are nuanced challenges, both regulatory and logistical, spanning donor eligibility, donor recruitment, collections, and transfusion itself. Data from rigorously controlled clinical trials of convalescent plasma are also few, underscoring the need to evaluate its use objectively for a range of indications (e.g., prevention vs. treatment) and patient populations (e.g., age, comorbid disease). We provide an overview of convalescent plasma, including evidence of benefit, regulatory considerations, logistical work flow, and proposed clinical trials, as scale-up is brought underway to mobilize this critical resource.
严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)是导致 2019 年冠状病毒病(COVID-19)的病原体,引发了全球卫生危机。迄今为止,对于已经接触过 SARS-CoV-2 的人,没有预防的方法;对于已经患有 COVID-19 的人,也没有治疗的方法。免疫(即“恢复期”)血浆是指从感染后康复并产生抗体的个体中收集的血浆。通过输注恢复期血浆进行被动抗体给药可能是为易感个体提供立即免疫的唯一短期策略。有许多例子表明,恢复期血浆已成功用于接触后预防和/或治疗传染病,包括其他冠状病毒爆发(例如 SARS-1、中东呼吸综合征 [MERS])。恢复期血浆也用于 COVID-19 大流行;来自中国的有限数据表明具有临床益处,包括影像学改善、病毒载量减少和生存率提高。全球范围内,血液中心具有强大的基础设施,可进行采集并构建恢复期血浆库存,以满足不断增长的需求。尽管如此,在监管和后勤方面都存在细微的挑战,包括供者资格、供者招募、采集和输血本身。严格控制的恢复期血浆临床试验的数据也很少,这突显了需要客观地评估其在一系列适应症(例如预防与治疗)和患者人群(例如年龄、合并症)中的使用。我们提供了恢复期血浆的概述,包括其益处的证据、监管考虑因素、后勤工作流程和拟议的临床试验,因为正在扩大规模以调动这一关键资源。