Song Gao, Cheng Meng Qun, Wei Xian Wen
Department of Pharmacy, Pu'er People's Hospital.
Department of Reproductive Medicine, The Pu'er People's Hospital.
Medicine (Baltimore). 2020 Oct 23;99(43):e22840. doi: 10.1097/MD.0000000000022840.
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.
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。