Department of Medicine, University of British Columbia, Vancouver, BC, Canada.
Department of Medicine, Division of Infectious Diseases, University of British Columbia, Vancouver, BC, Canada.
Clin Microbiol Infect. 2020 Oct;26(10):1436-1446. doi: 10.1016/j.cmi.2020.08.005. Epub 2020 Aug 11.
There is currently no treatment known to alter the course of coronavirus disease 2019 (COVID-19). Convalescent plasma has been used to treat a number of infections during pandemics, including severe acute respiratory syndrome coronavirus (SARS-CoV), Middle Eastern respiratory syndrome coronavirus (MERS-CoV) and now severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2).
To summarize the existing literature and registered clinical trials on the efficacy and safety of convalescent plasma for treating coronaviruses, and discuss issues of feasibility, and donor and patient selection.
A review of articles published in PubMed was performed on 13 July 2020 to summarize the currently available evidence in human studies for convalescent plasma as a treatment for coronaviruses. The World Health Organization International Clinical Trials Registry and clinicaltrials.gov were searched to summarize the currently registered randomized clinical trials for convalescent plasma in COVID-19.
There were sixteen COVID-19, four MERS and five SARS reports describing convalescent plasma use in humans. There were two randomized control trials, both of which were for COVID-19 and were terminated early. Most COVID-19 reports described a potential benefit of convalescent plasma on clinical outcomes in severe or critically ill patients with few immediate adverse events. However, there were a number of limitations, including the concurrent use of antivirals, steroids and other treatments, small sample sizes, lack of randomization or control groups, and short follow-up time. Data from SARS and COVID-19 suggest that earlier administration probably yields better outcomes. The ideal candidates for recipients and donors are not known. Still, experience with previous coronaviruses tells us that antibodies in convalescent patients are probably short-lived. Patients who had more severe disease and who are earlier in their course of recovery may be more likely to have adequate titres. Finally, a number of practical challenges were identified.
There is currently no effective treatment for COVID-19, and preliminary trials for convalescent plasma suggest that there may be some benefits. However, research to date is at high risk of bias, and randomized control trials are desperately needed to determine the efficacy and safety of this therapeutic option.
目前尚无已知方法可改变 2019 年冠状病毒病(COVID-19)的病程。在大流行期间,已使用恢复期血浆治疗了许多感染,包括严重急性呼吸综合征冠状病毒(SARS-CoV)、中东呼吸综合征冠状病毒(MERS-CoV),现在还包括严重急性呼吸综合征冠状病毒 2 型(SARS-CoV-2)。
总结恢复期血浆治疗冠状病毒的疗效和安全性的现有文献和已注册临床试验,并讨论可行性、供者和患者选择方面的问题。
2020 年 7 月 13 日,在 PubMed 上检索了已发表的文章,以总结目前人类研究中关于恢复期血浆作为冠状病毒治疗方法的现有证据。检索了世界卫生组织国际临床试验注册平台和 clinicaltrials.gov,以总结目前在 COVID-19 中注册的恢复期血浆的随机临床试验。
有 16 篇关于 COVID-19、4 篇关于 MERS 和 5 篇关于 SARS 的报告描述了人类使用恢复期血浆的情况。有两项随机对照试验,均针对 COVID-19 ,且提前终止。大多数 COVID-19 报告描述了在严重或危重症患者中,恢复期血浆对临床结局的潜在益处,且很少出现即时不良事件。但是,存在许多局限性,包括同时使用抗病毒药、类固醇和其他治疗方法、样本量小、缺乏随机分组或对照组以及随访时间短。来自 SARS 和 COVID-19 的数据表明,早期给药可能产生更好的结果。尚未确定供者和受者的理想人选。但是,我们从以前的冠状病毒感染中获得的经验表明,恢复期患者的抗体可能是短暂存在的。病情较重且处于恢复早期的患者可能更有可能具有足够的抗体滴度。最后,还确定了一些实际挑战。
目前尚无针对 COVID-19 的有效治疗方法,恢复期血浆的初步试验表明可能有一定的益处。但是,迄今为止的研究存在很高的偏倚风险,迫切需要进行随机对照试验来确定这种治疗选择的疗效和安全性。