Analysis of Clinical Research Characteristics of Clinical Study on Coronavirus Disease 2019:Based on International Clinical Trial Registration Platform
XIE Yang, ZHANG Peng, ZHAO Hulei, et al. Analysis of Clinical Research Characteristics of Clinical Study on Coronavirus Disease 2019:Based on International Clinical Trial Registration Platform[J]. Journal of Traditional Chinese Medicine2020, 61(15): 1294-1298.
XIE Yang, ZHANG Peng, ZHAO Hulei, et al. Analysis of Clinical Research Characteristics of Clinical Study on Coronavirus Disease 2019:Based on International Clinical Trial Registration Platform[J]. Journal of Traditional Chinese Medicine2020, 61(15): 1294-1298.DOI: 10.13288/j.11-2166/r.2020.15.002.
Objective To analyze the clinical research characteristics of clinical trials of coronavirus disease 2019(COVID-19) at home and abroad. Methods All clinical trials related to COVID-19 registered on the International Clinical Trial Registration Platform(ICTRP) were retrieved from January 1 st
2020 to February 7 th
2020
and a database was established to analyze the design types
research objects
stages and samples in clinical trials
and the characteristics of the control and blind method
intervention measures
intervention course
and outcome indicators in the pilot study. Results A total of 57 clinical trials of COVID-19 were retrieved
including 24 traditional Chinese medicine(TCM) studies. There were 51 pilot studies(89.47%) and 6 observational studies(10.53%); the main design type was random parallel controlled studies(41
71.93%). Among the interventions in pilot studies
27 were western medicine interventions(52.94%)
22 were Chinese medicine interventions(43.14%)
and 2 were behavioral interventions(3.92%); the outcome indicators were mainly viral negative evaluation
disease progression evaluation
symptom evaluation
quality of life evaluation and laboratory indicators. Conclusion The number of COVID-19 clinical trial registrations is increasing rapidly
but some trial registrations have problems including irregular information and incompleteness. TCM clinical research needs to further highlight the characteristics and advantages of TCM in terms of intervention measures and outcome indicators.