关键词: 新型冠状病毒肺炎, 新型冠状病毒, 临床试验, 干预方案

Abstract: 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.

Key words: COVID-19, SARS-Cov-2, clinical trial, intervention protocol