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- Title
Coronavirus Disease 2019 Related Clinical Studies: A Cross-Sectional Analysis.
- Authors
Ma, Lin-Lu; Yin, Xuan; Li, Bing-Hui; Yang, Jia-Yu; Jin, Ying-Hui; Huang, Di; Deng, Tong; Wang, Yun-Yun; Ren, Xue-Qun; Ji, Jianguang; Zeng, Xian-Tao
- Abstract
Objective: The quality and rationality of many recently registered clinical studies related to coronavirus disease 2019 (COVID-19) needs to be assessed. Hence, this study aims to evaluate the current status of COVID-19 related registered clinical trial. Methods: We did an electronic search of COVID-19 related clinical studies registered between December 1, 2019 and February 21, 2020 (updated to May 28, 2020) from the ClinicalTrials.gov , and collected registration information, study details, recruitment status, characteristics of the subjects, and relevant information about the trial implementation process. Results: A total of 1,706 studies were included 10.0% of which (n=171) were from France, 943 (55.3%) used an interventional design, and 600 (35.2%) used an observational design. Most of studies (73.6%) aimed to recruit fewer than 500 people. Interferon was the main prevention program, and antiviral drugs were the main treatment program. Hydroxychloroquine and chloroquine (230/943, 24.4%) were widely studied. Some registered clinical trials are incomplete in content, and 37.4% of the 1,706 studies may have had insufficient sample size. Conclusion: The quality of COVID-19 related studies needs to be improved by strengthening the registration process and improving the quality of clinical study protocols so that these clinical studies can provide high-quality clinical evidence related to COVID-19.
- Subjects
FRANCE; COVID-19; CROSS-sectional method; ANTIVIRAL agents; HYDROXYCHLOROQUINE; MEDICAL protocols
- Publication
Frontiers in Pharmacology, 2020, Vol 11, pN.PAG
- ISSN
1663-9812
- Publication type
Article
- DOI
10.3389/fphar.2020.540187