COVID-19恢复期血浆和临床试验:理解相互矛盾的结果。

IF 19 1区 医学 Q1 MICROBIOLOGY Clinical Microbiology Reviews Pub Date : 2022-09-21 Epub Date: 2022-03-09 DOI:10.1128/cmr.00200-21
Daniele Focosi, Massimo Franchini, Liise-Anne Pirofski, Thierry Burnouf, Nigel Paneth, Michael J Joyner, Arturo Casadevall
{"title":"COVID-19恢复期血浆和临床试验:理解相互矛盾的结果。","authors":"Daniele Focosi,&nbsp;Massimo Franchini,&nbsp;Liise-Anne Pirofski,&nbsp;Thierry Burnouf,&nbsp;Nigel Paneth,&nbsp;Michael J Joyner,&nbsp;Arturo Casadevall","doi":"10.1128/cmr.00200-21","DOIUrl":null,"url":null,"abstract":"<p><p>Convalescent plasma (CP) recurs as a frontline treatment in epidemics because it is available as soon as there are survivors. The COVID-19 pandemic represented the first large-scale opportunity to shed light on the mechanisms of action, safety, and efficacy of CP using modern evidence-based medicine approaches. Studies ranging from observational case series to randomized controlled trials (RCTs) have reported highly variable efficacy results for COVID-19 CP (CCP), resulting in uncertainty. We analyzed variables associated with efficacy, such as clinical settings, disease severity, CCP SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) antibody levels and function, dose, timing of administration (variously defined as time from onset of symptoms, molecular diagnosis, diagnosis of pneumonia, or hospitalization, or by serostatus), outcomes (defined as hospitalization, requirement for ventilation, clinical improvement, or mortality), CCP provenance and time for collection, and criteria for efficacy. The conflicting trial results, along with both recent WHO guidelines discouraging CCP usage and the recent expansion of the FDA emergency use authorization (EUA) to include outpatient use of CCP, create confusion for both clinicians and patients about the appropriate use of CCP. A review of 30 available RCTs demonstrated that signals of efficacy (including reductions in mortality) were more likely if the CCP neutralizing titer was >160 and the time to randomization was less than 9 days. The emergence of the Omicron variant also reminds us of the benefits of polyclonal antibody therapies, especially as a bridge to the development and availability of more specific therapies.</p>","PeriodicalId":10378,"journal":{"name":"Clinical Microbiology Reviews","volume":null,"pages":null},"PeriodicalIF":19.0000,"publicationDate":"2022-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9491201/pdf/","citationCount":"50","resultStr":"{\"title\":\"COVID-19 Convalescent Plasma and Clinical Trials: Understanding Conflicting Outcomes.\",\"authors\":\"Daniele Focosi,&nbsp;Massimo Franchini,&nbsp;Liise-Anne Pirofski,&nbsp;Thierry Burnouf,&nbsp;Nigel Paneth,&nbsp;Michael J Joyner,&nbsp;Arturo Casadevall\",\"doi\":\"10.1128/cmr.00200-21\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Convalescent plasma (CP) recurs as a frontline treatment in epidemics because it is available as soon as there are survivors. The COVID-19 pandemic represented the first large-scale opportunity to shed light on the mechanisms of action, safety, and efficacy of CP using modern evidence-based medicine approaches. Studies ranging from observational case series to randomized controlled trials (RCTs) have reported highly variable efficacy results for COVID-19 CP (CCP), resulting in uncertainty. We analyzed variables associated with efficacy, such as clinical settings, disease severity, CCP SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) antibody levels and function, dose, timing of administration (variously defined as time from onset of symptoms, molecular diagnosis, diagnosis of pneumonia, or hospitalization, or by serostatus), outcomes (defined as hospitalization, requirement for ventilation, clinical improvement, or mortality), CCP provenance and time for collection, and criteria for efficacy. The conflicting trial results, along with both recent WHO guidelines discouraging CCP usage and the recent expansion of the FDA emergency use authorization (EUA) to include outpatient use of CCP, create confusion for both clinicians and patients about the appropriate use of CCP. A review of 30 available RCTs demonstrated that signals of efficacy (including reductions in mortality) were more likely if the CCP neutralizing titer was >160 and the time to randomization was less than 9 days. The emergence of the Omicron variant also reminds us of the benefits of polyclonal antibody therapies, especially as a bridge to the development and availability of more specific therapies.</p>\",\"PeriodicalId\":10378,\"journal\":{\"name\":\"Clinical Microbiology Reviews\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":19.0000,\"publicationDate\":\"2022-09-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9491201/pdf/\",\"citationCount\":\"50\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Microbiology Reviews\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1128/cmr.00200-21\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2022/3/9 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"MICROBIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Microbiology Reviews","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1128/cmr.00200-21","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/3/9 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"MICROBIOLOGY","Score":null,"Total":0}
引用次数: 50

摘要

恢复期血浆(CP)作为流行病的一线治疗方法反复出现,因为一旦有幸存者就可以使用。新冠肺炎大流行代表了首次使用现代循证医学方法阐明CP的作用机制、安全性和疗效的大规模机会。从观察病例系列到随机对照试验(RCT)的研究报告了新冠肺炎CP(CCP)的高度可变的疗效结果,导致了不确定性。我们分析了与疗效相关的变量,如临床环境、疾病严重程度、CCP严重急性呼吸系统综合征冠状病毒2型抗体水平和功能、剂量、给药时间(不同定义为症状出现时间、分子诊断、肺炎诊断或住院或血清状态),结果(定义为住院、通气要求、临床改善或死亡率)、CCP来源和收集时间以及疗效标准。相互矛盾的试验结果,加上最近世界卫生组织的指导方针不鼓励CCP的使用,以及最近美国食品药品监督管理局紧急使用授权(EUA)的扩大,包括门诊使用CCP,使临床医生和患者对CCP的适当使用感到困惑。对30项可用随机对照试验的审查表明,如果CCP中和滴度为 >160,随机化时间小于9 天。奥密克戎变异株的出现也提醒我们多克隆抗体疗法的好处,特别是作为开发和获得更特异性疗法的桥梁。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

摘要图片

摘要图片

摘要图片

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
COVID-19 Convalescent Plasma and Clinical Trials: Understanding Conflicting Outcomes.

Convalescent plasma (CP) recurs as a frontline treatment in epidemics because it is available as soon as there are survivors. The COVID-19 pandemic represented the first large-scale opportunity to shed light on the mechanisms of action, safety, and efficacy of CP using modern evidence-based medicine approaches. Studies ranging from observational case series to randomized controlled trials (RCTs) have reported highly variable efficacy results for COVID-19 CP (CCP), resulting in uncertainty. We analyzed variables associated with efficacy, such as clinical settings, disease severity, CCP SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) antibody levels and function, dose, timing of administration (variously defined as time from onset of symptoms, molecular diagnosis, diagnosis of pneumonia, or hospitalization, or by serostatus), outcomes (defined as hospitalization, requirement for ventilation, clinical improvement, or mortality), CCP provenance and time for collection, and criteria for efficacy. The conflicting trial results, along with both recent WHO guidelines discouraging CCP usage and the recent expansion of the FDA emergency use authorization (EUA) to include outpatient use of CCP, create confusion for both clinicians and patients about the appropriate use of CCP. A review of 30 available RCTs demonstrated that signals of efficacy (including reductions in mortality) were more likely if the CCP neutralizing titer was >160 and the time to randomization was less than 9 days. The emergence of the Omicron variant also reminds us of the benefits of polyclonal antibody therapies, especially as a bridge to the development and availability of more specific therapies.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Clinical Microbiology Reviews
Clinical Microbiology Reviews 医学-微生物学
CiteScore
54.20
自引率
0.50%
发文量
38
期刊介绍: Clinical Microbiology Reviews (CMR) is a journal that primarily focuses on clinical microbiology and immunology.It aims to provide readers with up-to-date information on the latest developments in these fields.CMR also presents the current state of knowledge in clinical microbiology and immunology.Additionally, the journal offers balanced and thought-provoking perspectives on controversial issues in these areas.
期刊最新文献
American Society for Microbiology evidence-based laboratory medicine practice guidelines to reduce blood culture contamination rates: a systematic review and meta-analysis. Lyme borreliosis in Brazil: a critical review on the Baggio-Yoshinari syndrome (Brazilian Lyme-like disease). Comprehensive analysis of the global impact and distribution of tick paralysis, a deadly neurological yet fully reversible condition. Molecular diagnostics in cerebrospinal fluid for the diagnosis of central nervous system infections. Harnessing the host response for precision infectious disease diagnosis.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1