Current status of clinical trial registration regarding coronavirus disease 2019

Abstract

Objective　To summarize the main characteristics of clinical studies regarding coronavirus disease 2019 (COVID-19) registered on the Chinese and US NIH Official Clinical Trial Registration Websites. Methods　To search all the clinical studies about COVID-19 which were registered on the Chinese and U.S. NIH official clinical trial registration websites until March 9, 2020. The search terms were "new coronavirus pneumonia (COVID-19), 2019-nCoV, novel coronavirus pneumonia". Results　Overall, 360 studies with a total sample size of 268,773 participants are registered on Chinese clinical trial registration website, and 74 studies with a total sample size of 73,723 participants in the U.S. NIH clinical trial registration website. According to the information provided by the Chinese Clinical Trial Registration Website, there are 237 interventional studies, 108 observational studies, and 15 diagnostic test studies; and the most commonly studied interventions were Traditional Chinese Medicine in 80 studies, antiviral therapy in 58 studies, stem cells in 19 studies, plasma of recovered patients in 13 studies, glucocorticoid in 7 studies, molecular targeted therapy in 4 studies, and vaccine in 2 studies. According to the information provided by the U.S. NIH Clinical Trial Registration Website, there were 54 interventional studies, 17 observational studies, and 3 diagnostic test studies; and the most commonly studied interventions were antiviral therapy in 16 studies, stem cells in 7 studies, Traditional Chinese Medicine in 6 studies, molecular targeted therapy in 3 studies, and vaccine in 3 studies. Conclusions　Numerous clinical studies related to COVID-19 have been registered during a very short period. Among them, Traditional Chinese Medicine is the most commonly studied intervention, which suggests the Chinese characteristics in medical care. However, considering such a large sample size needed for these clinical studies, it is very important to ensure the enrollment of participants effectively and orderly in future. DOI: 10.11855/j.issn.0577-7402.2020.04.04