新冠肺炎临床试验注册特点分析：基于美国ClinicalTrials.gov和中国临床研究注册中心数据库

摘要/Abstract

摘要： 目的：分析注册于美国ClinicalTrials.gov与中国临床研究注册中心（Chinese Clinical Trial Registry，ChiCTR）的新型冠状病毒肺炎（COVID-19）临床试验的特点。方法：全面检索自ClinicalTrials.gov与ChiCTR数据库成立至2020年2月13日的COVID-19临床试验，记录并分析相关特征。结果：ChiCTR数据库COVID-19临床试验注册量为97项，ClinicalTrials.gov为19项，共计116项。湖北注册数量排名第1，浙江、北京并列第2，四川、广东并列第3；超过一半的研究正在征募研究对象，绝大部分临床试验已通过伦理审批；试验研究类型以干预性研究和观察性研究为主，其中干预性研究的试验设计大多数为随机平行对照试验；受试者研究数量与研究时限分别集中在100~199例与3~6个月区间；大部分临床试验处于探索性研究/预试验阶段，研究分期以Ⅳ期为主；西药治疗是COVID-19临床试验的主要治疗方式，其中洛匹那韦/利托那韦研究频次最多，其次为干扰素、氯喹/羟氯喹。结论：及时探讨该领域研究现状和发展态势，可快速为抗新型冠状病毒的研发提供基于情报学的数据基础和信息参考。

关键词: font-size:medium, ">ClinicalTrials.gov；ChiCTR；新型冠状病毒；临床试验；注册特点；新冠肺炎

Abstract: Objective：To analyze the features of clinical trials of corova virus disease 2019（COVID-19） registered in ClinicalTrials.gov and the Chinese Clinical Trial Registry (ChiCTR). Methods： Clinical trials were searched from ClinicalTrials.gov and ChiCTR database until February 13， 2020， and related features were recorded and analyzed. Results： There were 97 COVID-19 clinical trials registered in the ChiCTR database and 19 in ClinicalTrials.gov for a total of 116. Hubei ranked first in terms of number of registrations. Zhejiang and Beijing tied for second. Sichuan and Guangdong tied for third. More than half of the researches are recruiting research subjects， and most clinical trials have passed ethical approval. The types of trials are mostly interventional and observational studies. Most of the trial designs for interventional studies are randomized parallel controlled trials. The number of study subjects and the study period are concentrated in the range of 100 to 199 cases and 3 to 6 months respectively. Most clinical trials are exploratory research in the pre-test phase， and the research stage is mainly stage Ⅳ. Western medicine is the main treatment method for COVID-19 clinical trials. Among them， lopinavir/ritonavir is most frequently studied， followed by interferon and chloroquine/hydroxychloroquine. Conclusion： The timely discussion of the research status and development trends in this field can quickly provide an information-based data foundation and information reference for the development of anti-SARS-CoV-2.

Key words: font-size:medium, ">ClinicalTrials.gov； ChiCTR； SARS-CoV-2； Clinical trials； Registration features； COVID-19
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中图分类号:

宋杲, 成梦群. 新冠肺炎临床试验注册特点分析：基于美国ClinicalTrials.gov和中国临床研究注册中心数据库[J]. 中国医药导刊, 2020, 22(6): 369-374.

SONG Gao, CHENG Mengqun. Analysis of COVID-19 Clinical Trials Registration Features：Based on ClinicalTrials.gov and ChiCTR Database[J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 2020, 22(6): 369-374.

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