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2
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Characteristics and Strength of Evidence of COVID-19 Studies Registered on ClinicalTrials.gov.《ClinicalTrials.gov 上注册的 COVID-19 研究的特征和证据强度》
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R Soc Open Sci. 2023 Jan 11;10(1):201543. doi: 10.1098/rsos.201543. eCollection 2023 Jan.
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Does acute and persistent metabolic dysregulation in COVID-19 point to novel biomarkers and future therapeutic strategies?新冠肺炎中急性和持续的代谢失调是否指向新的生物标志物和未来的治疗策略?
Eur Respir J. 2022 Feb 24;59(2). doi: 10.1183/13993003.02417-2021. Print 2022 Feb.
3
Challenges and Lessons Learned From COVID-19 Trials: Should We Be Doing Clinical Trials Differently?从新冠病毒临床试验中吸取的经验教训:我们是否应该改变临床试验方式?
Can J Cardiol. 2021 Sep;37(9):1353-1364. doi: 10.1016/j.cjca.2021.05.009. Epub 2021 May 30.

本文引用的文献

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Preliminary evidence from a multicenter prospective observational study of the safety and efficacy of chloroquine for the treatment of COVID-19.一项关于氯喹治疗COVID-19安全性和有效性的多中心前瞻性观察性研究的初步证据。
Natl Sci Rev. 2020 May 28;7(9):1428-1436. doi: 10.1093/nsr/nwaa113. eCollection 2020 Sep.
2
RETRACTED: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis.撤回:羟氯喹或氯喹联合或不联合大环内酯类药物治疗新型冠状病毒肺炎:一项多国注册分析
Lancet. 2020 May 22. doi: 10.1016/S0140-6736(20)31180-6.
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Convalescent plasma in Covid-19: Possible mechanisms of action.恢复期血浆治疗 COVID-19:可能的作用机制。
Autoimmun Rev. 2020 Jul;19(7):102554. doi: 10.1016/j.autrev.2020.102554. Epub 2020 May 5.
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Coronavirus drugs: Using plasma from recovered patients as a treatment for COVID-19.冠状病毒药物:使用康复患者的血浆治疗新冠肺炎。
Int J Risk Saf Med. 2020;31(2):47-51. doi: 10.3233/JRS-201017.
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Current Status of Epidemiology, Diagnosis, Therapeutics, and Vaccines for Novel Coronavirus Disease 2019 (COVID-19).新型冠状病毒病 2019(COVID-19)的流行病学、诊断、治疗和疫苗的现状。
J Microbiol Biotechnol. 2020 Mar 28;30(3):313-324. doi: 10.4014/jmb.2003.03011.
6
Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure.人类挑战研究加速冠状病毒疫苗许可。
J Infect Dis. 2020 May 11;221(11):1752-1756. doi: 10.1093/infdis/jiaa152.
7
The SARS-CoV-2 Vaccine Pipeline: an Overview.严重急性呼吸综合征冠状病毒2型疫苗研发进展概述
Curr Trop Med Rep. 2020;7(2):61-64. doi: 10.1007/s40475-020-00201-6. Epub 2020 Mar 3.
8
COVID-19: Vulnerability and the power of privilege in a pandemic.新冠疫情:大流行中的脆弱性与特权的力量
Health Promot J Austr. 2020 Apr;31(2):158-160. doi: 10.1002/hpja.333. Epub 2020 Mar 20.
9
2019 novel coronavirus (2019-nCoV) outbreak: A new challenge.2019 新型冠状病毒(2019-nCoV)爆发:新的挑战。
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10
Compounds with Therapeutic Potential against Novel Respiratory 2019 Coronavirus.具有治疗新型呼吸道 2019 冠状病毒潜力的化合物。
Antimicrob Agents Chemother. 2020 Apr 21;64(5). doi: 10.1128/AAC.00399-20.

世界卫生组织国际临床试验注册平台(ICTRP)关于新型冠状病毒临床试验注册情况的分析。

Analysis of the WHO ICTRP for novel coronavirus clinical trial registrations.

作者信息

Song Gao, Cheng Meng Qun, Wei Xian Wen

机构信息

Department of Pharmacy, Pu'er People's Hospital.

Department of Reproductive Medicine, The Pu'er People's Hospital.

出版信息

Medicine (Baltimore). 2020 Oct 23;99(43):e22840. doi: 10.1097/MD.0000000000022840.

DOI:10.1097/MD.0000000000022840
PMID:33120812
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7581159/
Abstract

Up-to-date information on the current progress made in the research and development to control the global COVID-19 pandemic is important. The study aimed to analyze the clinical trial characteristics and vaccine development progress of the new Coronavirus Disease 2019 (COVID-19) registered with the World Health Organization International Clinical Trial Registry Platform (WHO ICTRP).A comprehensive search of COVID-19 clinical trials since the establishment of the ICTRP to June 11, 2020, was conducted to record and analyze relevant characteristics. Chi-Squared test was used to compare the statistical differences between different research types, interventions, and sources.A total of 3282 COVID-19 clinical trials in 17 clinical trial registration centers were registered with the WHO ICTRP. The main research sources for the present study were ClinicalTrials.gov and ChiCTR. There were significant differences in the parameters of study location (P = .000), number of participants (P = .000), study duration (P = .001), research stage (P = .000), randomization procedure (P = .000), and blinding method (P = .000) between the 2 registration sources. There were significant differences in all the parameters between different kinds of intervention methods. Hydroxychloroquine, plasma therapy, and Xiyanping injection were the high-frequency research drugs used. Ten different vaccine studies were registered under phases I-II.Amongst the studies researched, heterogeneity existed for various parameters. Differences in the type of study, interventions, and registration sources of the studies led to significant differences in certain parameters of the COVID-19 clinical trials. The statistics of high-frequency drugs and the progress of vaccine trials may provide an informative reference for the prevention and control of COVID-19.

摘要

了解全球控制新冠疫情研发工作的最新进展信息非常重要。本研究旨在分析在世界卫生组织国际临床试验注册平台(WHO ICTRP)注册的2019新型冠状病毒病(COVID-19)的临床试验特征和疫苗研发进展。对自ICTRP成立至2020年6月11日的COVID-19临床试验进行全面检索,以记录和分析相关特征。采用卡方检验比较不同研究类型、干预措施和来源之间的统计差异。共有17个临床试验注册中心的3282项COVID-19临床试验在WHO ICTRP上注册。本研究的主要研究来源是ClinicalTrials.gov和中国临床试验注册中心(ChiCTR)。两个注册来源在研究地点参数(P = 0.000)、参与者数量(P = 0.000)、研究持续时间(P = 0.001)、研究阶段(P = 0.000)、随机化程序(P = 0.000)和盲法(P = 0.000)方面存在显著差异。不同干预方法的所有参数之间均存在显著差异。羟氯喹、血浆疗法和喜炎平注射液是高频研究药物。有10项不同的疫苗研究在I-II期注册。在所研究的试验中,各项参数存在异质性。研究类型、干预措施和注册来源的差异导致COVID-19临床试验的某些参数存在显著差异。高频药物统计和疫苗试验进展可为COVID-19的防控提供有益参考。