Focusing on the Treatment of COVID-19: A Comprehensive Analysis of 226 Trials Registered on ClinicalTrials.gov and ChiCTR
21 Pages Posted: 31 Mar 2020More...
Objective: There are many clinical trials on the treatment of Coronavirus Disease 2019 (COVID-19), however, there is a lack of systematic understanding of the clinical trials of COVID-19. The purpose of this study is to analyze the registration clinical trials of COVID-19, and to provide a reference for the clinical treatment.
Methods: Chinese ClinicalTrial Registry (ChiCTR) and clinicaltrial.gov were searched for Clinical trials of COVID-19, which registered from inception to February 29, 2020, to screen out Clinical trials on the treatment of COVID-19, and the research units and regions, sample size, study types, study stages and intervention measures were analyzed.
Results: There were 226 clinical trials on COVID-19 in the two databases, all of which were registered by research units in China. The top five registered areas were Hubei, Beijing, Shanghai, Guangdong, and Zhejiang. Study type: intervention study (207, 91.6%), observational study (18, 8.0%). Clinical trial staging: exploratory studies/preliminary trials (91, 40.3%), phase I trials (4, 1.8%), phase II trials (12, 5.3%), phase III trials (12, 5.3%), phase IV (47, 20.8%), phase I/II (2, 0.9%), phase II/III(5, 2.2%), and others (57, 25.2%). Intervention measures: 143(63.3%) trials of western medicine treatment, 50 (22.1%)trials of Chinese medicine treatment, 21(9.3%) trials of integrated Chinese medicine treatment and western medicine treatment.
Conclusion: Researchers have registered a large number of clinical trials in a short time. The number of existing patients of COVID-19 is not enough to support hundreds of clinical trials. The design of multicenter, randomized, double-blind, placebo-controlled trials is lacking.
Funding Statement: Our study was supported by the Natural Science Foundation of Hunan Province (No. 2019JJ80054 and No. 2019JJ80055), the Scientific Research Project of the Hunan Health Commission (No. B2019133), and Research Project Funding of the Changsha Municipal Health and Family Planning Commission (No. 201809).
Declaration of Interests: The authors declare that there are no competing interests.
Keywords: Clinicaltrials. gov; ChiCTR; Coronavirus Disease 2019 (COVID-19); Treatment; Clinical trials; Register features
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