关键词: 新型冠状病毒, 临床试验, 化学药, 中药, 生物制品

Abstract: AIM: To provide suggestion for research and development of drugs against coronavirus disease 2019 (COVID-19) by analyzing the characteristics of the drug clinical trial registration information of COVID-19 in China. METHODS: The clinical trials of COVID-19 were searched from Chinese Clinical Trial Registry, and the type, purpose, and design of the studies were analyzed. RESULTS: Totally 271 drug clinical trials have been registered till July 1st, 2020. Most of the drugs are marketed ones, including chemical drugs, traditional Chinese medicines, and biologics. Combined applications were adopted in some projects. Randomized or non-randomized parallel control trials were conducted in most projects. Others included single arm, sequential, and factorial design. CONCLUSION: To deal with the epidemic, it is important to conduct emergent drug clinical trials to find out effective drugs as soon as possible. However, some weaknesses and deficiencies on trials design, conduct and supervision were exposed in the drug clinical trials against COVID-19. It is suggested to enhance the scientific evaluation of candidate drugs, standardize the investigator initiated trials, and establish the national multi-subject research and development platform, and the collaborative and innovative key-task tackling mechanism, thus to improve the ability and level of antiviral drug research and development.

Key words: novel coronavirus (SARS-CoV-2), clinical trial, chemical drug, traditional Chinese medicine, biological products