摘要目的:基于美国临床试验数据库(ClinicalTrials.gov)和中国临床试验注册中心的信息，全面了解全球新型冠状病毒肺炎(COVID-19)临床研究的注册特点。方法:分别检索美国临床试验数据库和中国临床试验注册中心注册的COVID-19相关临床试验，检索起始时间不限，截止时间分别为2020年12月14日和2021年3月19日。采用文献计量学的方法从注册量、注册提交时间、国家/地区、招募状态、研究类型、招募人数和研究阶段等方面对全球COVID-19注册特点进行分析。结果:截至2021年3月19日，中国临床试验注册中心注册COVID-19临床试验775项。截至2020年12月14日，美国临床试验数据库注册COVID-19临床试验4 137项，3 157项(76.31%)临床试验招募的受试者为年龄≥18岁的人群，干预性研究2 347项，观察性研究1 759项。干预措施主要为药物治疗、生物制品和器械治疗。干预性研究招募人数为110(48，308)例，观察性研究的招募人数为300(100，1 000)例。干预性研究的临床分期以Ⅱ期(570项)和Ⅲ期(358项)为主。COVID-19临床试验处于招募状态的最多，占50.33%(2 082/4 137), 542项(13.10%)临床试验已经完成。干预性研究中，多中心研究数量为729项(31.06%)，参与研究的中心数量为5(2，15)个。结论:目前全球开展COVID-19相关临床试验数量多，干预措施多样，但招募人数不尽合理，多机构合作的多中心研究较少。

abstractsObjective:To get comprehensive understanding of the registration characteristics of global clinical trials of coronavirus disease 2019(COVID-19) based on the ClinicalTrials. gov and the Chinese Clinical Trial Registry (ChiCTR).Methods:The clinical trials of COVID-19 in the ClinicalTrials.gov and ChiCTR were retrieved. The search start time was unlimited, with deadlines of 14 December, 2020 and 19 March, 2021, respectively. The registration numbers, registration submitted time, country/region distribution, recruitment status, study types, number of recruits, research phases, and other aspects were analyzed by using bibliometric methods.Results:As of March 19, 2021, there were 775 clinical trials in ChiCTR. As of December 14, 2020, there were 4 137 clinical trials in the ClinicalTrials.gov, and 3 157(76.31%) of the clinical trials recruited subjects who were aged≥18 years old. There were 2 347 intervention trials and 1 759 observational trials. The intervention measures mainly included drugs, biologics and medical devices. The numbers of recruits were 110(48, 308) cases for interventional studies, and 300(100, 1 000) cases for observational trials. The interventional research phases were mainly phaseⅡ (570 items) and phase Ⅲ (358 items). Totally, 50.33%(2 082/4 137) of the clinical trials were under recruitment, 13.10%(542/4 137) had been completed. Among the interventional studies, 729(31.06%) were multi-center studies, with the center numbers of 5(2, 15).Conclusions:At present, there are a large number of clinical trials with various intervention measures in the world. However, the number of recruits is unreasonable, and multi-center study with multi-agency cooperation is insufficient.