AIM: To provide advice for the clinical trials during the outbreak by analyzing the clinical trial registration information of COVID-19 in China .
METHODS: Clinical protocols of COVID-19 registered at the Chinese Clinical Trials Registry and clinicaltrials.gov before February 17 , 2020 were collected and the type, distribution, design and interventions of the studies were analyzed.
RESULTS: A total of 172 trials were retrieved, mainly distributed in Hubei, Zhejiang, Guangdong and Beijing . Among the 120 interventional studies, chemical drugs and biological products accounted for 45%, traditional Chinese medicine or integrative medicine therapy accounted for 40%, cell therapy accounted for 7%, and plasma therapy accounted for 2% . There were only 13 randomized, blinded and placebo controlled studies, accounting for 11% . Blank control reached 46% (control group with clinical routine treatment without placebo, test group with clinical routine treatment as the basic). HIV and antimalarial drugs were the most frequently used .
CONCLUSION: Chinese clinical research capacity and awareness have been greatly improved, but it is somewhat disordered . It is necessary to pay attention to the necessity, scientific nature, ethics and quality management of clinical research . It is recommended to initiate clinical trials coordinated and unified demonstration and to collect the national case information for big data analysis by the state during an emergency outbreak.