LI Shaohong, WANG Yuguang, HE Liyun, et al. Analysis of Registered Clinical Trials of Coronavirus Disease 2019: Existing Problems and Suggestions[J]. Journal of Traditional Chinese Medicine2020, 61(23): 2025-2030.
LI Shaohong, WANG Yuguang, HE Liyun, et al. Analysis of Registered Clinical Trials of Coronavirus Disease 2019: Existing Problems and Suggestions[J]. Journal of Traditional Chinese Medicine2020, 61(23): 2025-2030.DOI: 10.13288/j.11-2166/r.2020.23.001.
Objective To analyze the registered clinical trials of coronavirus disease 2019(COVID-19) in China and abroad and to summarize existing problems and make suggestions. Methods The COVID-19 clinical trials registered at the Chinese Clinical Trial Registry and clinical trial resitration in the United States(clinicaltrials.gov) from December 1 st 2019 to February 17 th
2020 were retrieved
and the key information was extracted and evaluated to analyze problems. Results A total of 164 registered studies were enrolled including 140 at Chinese clinical trial registration centers and 24 at clinicaltrials.gov. Hubei had the largest number of registrations(53)
followed by Zhejiang(21); 108(65.85%) interventional studies
46(28.05%) observational studies
10(6.10%) preventive and diagnostic studies; 117(71.34%) Western medicine related studies
35(21.34%) Chinese medicine related studies
12(7.32%) integrated traditional Chinese and Western medicine related studies. Among the intervention measures of TCM
the comprehensive treatment of traditional Chinese medicine(TCM)
integrated traditional Chinese and Western medicine treatment and the treatment based on syndrome differentiation were the main ones. The total sample size of the study was from 10 cases to 400 cases; 128 trials took mild and common types as the research objects. In interventional clinical studies
52 studies took time or rate of negative conversion of the virus as the outcome
followed by 41 studies on clinical recovery/clinical remission
32 studies on lung function
lung imaging indicators
and 23 studies on mortality rate and the critically ill or critically ill conversion rate. Conclusion The currently registered clinical studies on COVID-19 show diversified characteristics. It is recommended to further explore the advantages of TCM in treatment of severe and critical illness
pay attention to TCM treatment in the recovery period
and strengthen the epidemiological investigation and stuides on syndromes related to the etiology and pathogenesis of TCM.