WHO Collaborating Centre for Reference and Research on Influenza, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC 3000, Australia.
Department of Microbiology and Immunology, University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC 3000, Australia.
Eur J Immunol. 2020 Oct;50(10):1447-1453. doi: 10.1002/eji.202048723. Epub 2020 Sep 22.
The COVID-19 pandemic caused by the zoonotic coronavirus, SARS-CoV-2 has swept the world in 5 months. A proportion of cases develop severe respiratory tract infections progressing to acute respiratory distress syndrome and a diverse set of complications involving different organ systems. Faced with a lack of coronavirus-specific antiviral drugs and vaccines, hundreds of clinical trials have been undertaken to evaluate repurposed drugs. Convalescent plasma from recovered patients is an attractive option because antibodies can have direct or indirect antiviral activity and immunotherapy works well in principle, in animal models, and in anecdotal reports. However, the benefits of convalescent plasma treatment can only be clearly established through carefully designed randomized clinical trials. The experience from investigations of convalescent plasma products for severe influenza offers a cautionary tale. Despite promising pilot studies, large multicenter randomized controlled trials failed to show a benefit of convalescent plasma or hyperimmune intravenous globulin for the treatment of severe influenza A virus infection. These studies provide important lessons that should inform the planning of adequately powered randomized controlled trials to evaluate the promise of convalescent plasma therapy in COVID-19 patients.
由人畜共患冠状病毒 SARS-CoV-2 引起的 COVID-19 大流行在 5 个月内席卷全球。一部分病例发展为严重的呼吸道感染，进而发展为急性呼吸窘迫综合征和一系列涉及不同器官系统的并发症。由于缺乏冠状病毒特异性抗病毒药物和疫苗，已经进行了数百项临床试验来评估已上市药物的新用途。从康复患者中提取的恢复期血浆是一种有吸引力的选择，因为抗体可以具有直接或间接的抗病毒活性，免疫疗法在理论上、动物模型中和零星报告中效果良好。然而，只有通过精心设计的随机临床试验才能明确确定恢复期血浆治疗的益处。从严重流感的恢复期血浆制品研究中获得的经验提供了一个警示故事。尽管有有前景的初步研究，但大型多中心随机对照试验未能表明恢复期血浆或高免疫静脉球蛋白对治疗严重甲型流感病毒感染有获益。这些研究提供了重要的经验教训，应该为计划充分有效的随机对照试验提供信息，以评估恢复期血浆疗法在 COVID-19 患者中的应用前景。
