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探讨 COVID19 恢复期血浆疗效试验的可能性艺术。

The art of the possible in approaching efficacy trials for COVID19 convalescent plasma.

机构信息

North-Western Tuscany Blood Bank, Pisa University Hospital, Pisa, Italy.

Faculty of Medicine and Medical Sciences, The University of Western Australia, Perth, Australia.

出版信息

Int J Infect Dis. 2021 Jan;102:244-246. doi: 10.1016/j.ijid.2020.10.074. Epub 2020 Oct 30.

DOI:10.1016/j.ijid.2020.10.074
PMID:33130197
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7836915/
Abstract

COVID-19 convalescent plasma (CCP) is widely used as a treatment. While safety data are enough, high-level evidences of efficacy are still missing. We summarize here the results from randomized controlled trials (RCT) published to date and analyze their flaws and biases. We then provide suggestions for next round of CCP RCTs, discussing specification of CCP, therapeutic dose, timing, control arm, disease stage, and outcome measures.

摘要

COVID-19 恢复期血浆(CCP)被广泛用作治疗方法。虽然安全性数据充足,但仍缺乏高等级的疗效证据。我们在这里总结了迄今为止发表的随机对照试验(RCT)的结果,并分析了它们的缺陷和偏差。然后,我们为下一轮 CCP RCT 提供了建议,讨论了 CCP 的具体规定、治疗剂量、时机、对照臂、疾病阶段和结果测量。

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The art of the possible in approaching efficacy trials for COVID19 convalescent plasma.探讨 COVID19 恢复期血浆疗效试验的可能性艺术。
Int J Infect Dis. 2021 Jan;102:244-246. doi: 10.1016/j.ijid.2020.10.074. Epub 2020 Oct 30.
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Transfus Med. 2021 Dec;31(6):409-420. doi: 10.1111/tme.12803. Epub 2021 Jun 29.
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Landscape of humoral immune responses against SARS-CoV-2 in patients with COVID-19 disease and the value of antibody testing.新冠病毒疾病患者针对严重急性呼吸综合征冠状病毒2的体液免疫反应格局及抗体检测的价值
Heliyon. 2021 Apr;7(4):e06836. doi: 10.1016/j.heliyon.2021.e06836. Epub 2021 Apr 17.
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本文引用的文献

1
Impact of pathogen reduction methods on immunological properties of the COVID-19 convalescent plasma.病原体减少处理方法对 COVID-19 恢复期血浆免疫特性的影响。
Vox Sang. 2021 Jul;116(6):665-672. doi: 10.1111/vox.13056. Epub 2021 Mar 18.
2
Early versus deferred anti-SARS-CoV-2 convalescent plasma in patients admitted for COVID-19: A randomized phase II clinical trial.早期与延迟使用抗 SARS-CoV-2 恢复期血浆治疗因 COVID-19 住院患者:一项随机 II 期临床试验。
PLoS Med. 2021 Mar 3;18(3):e1003415. doi: 10.1371/journal.pmed.1003415. eCollection 2021 Mar.
3
Viral infection neutralization tests: A focus on severe acute respiratory syndrome-coronavirus-2 with implications for convalescent plasma therapy.病毒感染中和试验:聚焦严重急性呼吸综合征冠状病毒2及其对恢复期血浆治疗的意义
Rev Med Virol. 2021 Mar;31(2):e2170. doi: 10.1002/rmv.2170. Epub 2020 Sep 21.
4
Significantly Decreased Mortality in a Large Cohort of Coronavirus Disease 2019 (COVID-19) Patients Transfused Early with Convalescent Plasma Containing High-Titer Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike Protein IgG.在一大群2019冠状病毒病(COVID-19)患者中,早期输注含有高滴度抗严重急性呼吸综合征冠状病毒2(SARS-CoV-2)刺突蛋白IgG的康复期血浆可显著降低死亡率。
Am J Pathol. 2021 Jan;191(1):90-107. doi: 10.1016/j.ajpath.2020.10.008. Epub 2020 Nov 4.
5
Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial).恢复期血浆治疗印度成人中度 COVID-19 的管理:开放标签 II 期多中心随机对照试验(PLACID 试验)。
BMJ. 2020 Oct 22;371:m3939. doi: 10.1136/bmj.m3939.
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What is the optimal usage of coronavirus disease 2019 convalescent plasma donations?2019年冠状病毒病康复期血浆捐献的最佳用途是什么?
Clin Microbiol Infect. 2021 Feb;27(2):163-165. doi: 10.1016/j.cmi.2020.09.036. Epub 2020 Sep 29.
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Convalescent plasma treatment of severe COVID-19: a propensity score-matched control study.恢复期血浆治疗重症 COVID-19:一项倾向评分匹配对照研究。
Nat Med. 2020 Nov;26(11):1708-1713. doi: 10.1038/s41591-020-1088-9. Epub 2020 Sep 15.
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Impact of convalescent and nonimmune plasma on mortality of patients with COVID-19: a potential role for antithrombin.康复期血浆和非免疫血浆对COVID-19患者死亡率的影响:抗凝血酶的潜在作用。
Clin Microbiol Infect. 2021 Apr;27(4):637-638. doi: 10.1016/j.cmi.2020.09.007. Epub 2020 Sep 9.
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Convalescent plasma treatment for COVID-19: Tempering expectations with the influenza experience.恢复期血浆治疗 COVID-19:从流感经验中调整预期。
Eur J Immunol. 2020 Oct;50(10):1447-1453. doi: 10.1002/eji.202048723. Epub 2020 Sep 22.
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Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients.安全性更新:20000 例住院患者的 COVID-19 恢复期血浆。
Mayo Clin Proc. 2020 Sep;95(9):1888-1897. doi: 10.1016/j.mayocp.2020.06.028. Epub 2020 Jul 19.