新型冠状病毒肺炎临床研究注册现状分析

Current status of clinical trial registration regarding coronavirus disease 2019

目的汇总分析在中国和美国临床试验注册官方网站注册的有关新型冠状病毒肺炎(COVID-19)的临床研究的特征。方法检索截至2020年3月9日在中国和美国临床试验注册官方网站注册的有关COVID-19的临床研究。检索词为"新型冠状病毒肺炎(COVID-19)"、"2019-nCoV"和"novel coronavirus pneumonia"。结果目前共有360项研究注册于中国临床试验注册中心,预计样本量为268773例;74项研究注册于美国NIH临床试验注册网站,预计样本量为73723例。根据网站提供的信息,中国临床试验注册中心注册的研究中,干预性研究237项,观察性研究108项,诊断试验性研究15项,主要干预措施包括中医辨证论治(80项)、抗病毒治疗(58项)、干细胞治疗(19项)、康复者血浆治疗(13项)、激素治疗(7项)、分子靶向治疗(4项)和疫苗(2项);美国NIH临床试验注册网站注册的研究中,干预性研究54项,观察性研究17项,诊断试验性研究3项,主要干预措施包括抗病毒治疗(16项)、干细胞治疗(7项)、中医辨证论治(6项)、分子靶向治疗(3项)和疫苗(3项)。结论COVID-19引起了我国学者的高度重视,短期内已有大量临床研究注册,其中以干预性研究为主,中医辨证论治是最常被研究的干预措施,充分说明了我国的中医治疗特色。这些研究所需的样本量非常大,保证研究有序、高效地入组受试者是未来需要关注的重点。

Objective To summarize the main characteristics of clinical studies regarding coronavirus disease 2019(COVID-19)registered on the Chinese and US NIH Official Clinical Trial Registration Websites.Methods To search all the clinical studies about COVID-19 which were registered on the Chinese and U.S.NIH official clinical trial registration websites until March 9,2020.The search terms were"new coronavirus pneumonia(COVID-19),2019-nCoV,novel coronavirus pneumonia".Results Overall,360 studies with a total sample size of 268,773 participants are registered on Chinese clinical trial registration website,and 74 studies with a total sample size of 73,723 participants in the U.S.NIH clinical trial registration website.According to the information provided by the Chinese Clinical Trial Registration Website,there are 237 interventional studies,108 observational studies,and 15 diagnostic test studies;and the most commonly studied interventions were Traditional Chinese Medicine in 80 studies,antiviral therapy in 58 studies,stem cells in 19 studies,plasma of recovered patients in 13 studies,glucocorticoid in 7 studies,molecular targeted therapy in 4 studies,and vaccine in 2 studies.According to the information provided by the U.S.NIH Clinical Trial Registration Website,there were 54 interventional studies,17 observational studies,and 3 diagnostic test studies;and the most commonly studied interventions were antiviral therapy in 16 studies,stem cells in 7 studies,Traditional Chinese Medicine in 6 studies,molecular targeted therapy in 3 studies,and vaccine in 3 studies.Conclusions Numerous clinical studies related to COVID-19 have been registered during a very short period.Among them,Traditional Chinese Medicine is the most commonly studied intervention,which suggests the Chinese characteristics in medical care.However,considering such a large sample size needed for these clinical studies,it is very important to ensure the enrollment of participants effectively and orderly in future.