Characteristics of COVID 19 Clinical Trials in China Based on the Registration Data on ChiCTR and ClinicalTrials.gov
Objective This study aimed to evaluate the fundamental characteristics of coronavirus disease (COVID 19) clinical trials registered in China. Methods COVID 19 clinical trials registered in China were analyzed from databases on ChiCTR and ClinicalTrials.gov. The study designs, samples, primary end points, and intervention measures were evaluated. Results In total, 262 intervention clinical trials were retrieved on March 10, 2020. Overall, 181 (69.1% trials involved two groups, 200 (76.3% trials were randomized parallel trials, 24 (9.2% trials were double blind, and 60.3% of trials included =100 participants. Sixty (22.9% trials considered symptom improvement as the primary endpoint and 43 (16.4% trials considered the rate or time at which the subjects became virus free as the primary endpoint. Of 262 intervention studies, chemical drugs and biological products were studied in 105 (40.1% intervention studies, of which antiviral drugs accounted for 15.3% and malaria drugs accounted for 8.4% of the studies. Among all trials, 27.9% of the studies used traditional Chinese medicine (TCM) 10.3% used cell therapy, and 5.0% used plasma therapy. Conclusion This study is the first snapshot of the landscape of COVID 19 clinical trials registered in China and provided the basic features of clinical trial designs for the treatment and prevention of COVID 19 to offer useful information to guide future clinical trials on COVID 19 in other countries.
Drug design, development and therapy