Focusing on the Treatment of COVID-19: A Comprehensive Analysis of 226 Trials Registered on Clinicaltrials.gov and ChiCTR (preprint)

ABSTRACT

Background: The purpose of this study is to analyze the registered clinical trials of COVID-19, and to provide a reference for the clinical treatment of COVID-19. Methods: Chinese ClinicalTrial Registry (ChiCTR) and Clinicaltrials.gov databases were searched for clinical trials of COVID-19, which were registered from inception to February 29, 2020, to screen out the 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 2 databases, and all of them were registered by research units in China. The top five registered areas were Hubei, Beijing, Shanghai, Guangdong, and Zhejiang. The study type was as follows interventional study (207, 91.6%) and observational study (18, 8.0%). Clinical trial staging was as follows 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 trials (47, 20.8%), phase I/II trials (2, 0.9%), phase II/III trials (5, 2.2%), and other trials (57, 25.2%). Intervention measures were as follows there were 143 (63.3%) trials of western medicine treatment, 50 (22.1%) trials of Chinese medicine treatment, and 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. There is a lack of multicenter, randomized, double-blind, placebo-controlled trials.