Coronavirus Disease 2019 Related Clinical Studies: A Cross-Sectional Analysis
ObjectiveThe 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.MethodsWe did an electronic search of COVID-19 re...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2020-09-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/article/10.3389/fphar.2020.540187/full |
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| author | Lin-Lu Ma Xuan Yin Bing-Hui Li Bing-Hui Li Jia-Yu Yang Jia-Yu Yang Ying-Hui Jin Di Huang Tong Deng Yun-Yun Wang Xue-Qun Ren Jianguang Ji Xian-Tao Zeng |
| author_facet | Lin-Lu Ma Xuan Yin Bing-Hui Li Bing-Hui Li Jia-Yu Yang Jia-Yu Yang Ying-Hui Jin Di Huang Tong Deng Yun-Yun Wang Xue-Qun Ren Jianguang Ji Xian-Tao Zeng |
| author_sort | Lin-Lu Ma |
| collection | DOAJ |
| description | ObjectiveThe 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.MethodsWe 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.ResultsA 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.ConclusionThe 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. |
| first_indexed | 2024-12-22T11:53:32Z |
| format | Article |
| id | doaj.art-94083bb432c74ab39c9bde9a07885507 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-12-22T11:53:32Z |
| publishDate | 2020-09-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-94083bb432c74ab39c9bde9a078855072022-12-21T18:26:55ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122020-09-011110.3389/fphar.2020.540187540187Coronavirus Disease 2019 Related Clinical Studies: A Cross-Sectional AnalysisLin-Lu Ma0Xuan Yin1Bing-Hui Li2Bing-Hui Li3Jia-Yu Yang4Jia-Yu Yang5Ying-Hui Jin6Di Huang7Tong Deng8Yun-Yun Wang9Xue-Qun Ren10Jianguang Ji11Xian-Tao Zeng12Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan, ChinaDepartment of Rehabilitation, Taihe Hospital, Hubei University of Medicine, Shiyan, ChinaCenter for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan, ChinaInstitutes of Evidence-Based Medicine and Knowledge Translation, Henan University, Kaifeng, ChinaCenter for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan, ChinaAdministrative Office of Hospital Director, Zhongnan Hospital of Wuhan University, Wuhan, ChinaCenter for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan, ChinaCenter for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan, ChinaInstitutes of Evidence-Based Medicine and Knowledge Translation, Henan University, Kaifeng, ChinaCenter for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan, ChinaInstitutes of Evidence-Based Medicine and Knowledge Translation, Henan University, Kaifeng, ChinaCenter for Primary Health Care Research, Lund University/Region Skåne, Malmö, SwedenCenter for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan, ChinaObjectiveThe 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.MethodsWe 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.ResultsA 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.ConclusionThe 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.https://www.frontiersin.org/article/10.3389/fphar.2020.540187/fullcoronavirus disease 2019SARS-CoV-2clinical trialregistrationClinicalTrials.gov |
| spellingShingle | Lin-Lu Ma Xuan Yin Bing-Hui Li Bing-Hui Li Jia-Yu Yang Jia-Yu Yang Ying-Hui Jin Di Huang Tong Deng Yun-Yun Wang Xue-Qun Ren Jianguang Ji Xian-Tao Zeng Coronavirus Disease 2019 Related Clinical Studies: A Cross-Sectional Analysis Frontiers in Pharmacology coronavirus disease 2019 SARS-CoV-2 clinical trial registration ClinicalTrials.gov |
| title | Coronavirus Disease 2019 Related Clinical Studies: A Cross-Sectional Analysis |
| title_full | Coronavirus Disease 2019 Related Clinical Studies: A Cross-Sectional Analysis |
| title_fullStr | Coronavirus Disease 2019 Related Clinical Studies: A Cross-Sectional Analysis |
| title_full_unstemmed | Coronavirus Disease 2019 Related Clinical Studies: A Cross-Sectional Analysis |
| title_short | Coronavirus Disease 2019 Related Clinical Studies: A Cross-Sectional Analysis |
| title_sort | coronavirus disease 2019 related clinical studies a cross sectional analysis |
| topic | coronavirus disease 2019 SARS-CoV-2 clinical trial registration ClinicalTrials.gov |
| url | https://www.frontiersin.org/article/10.3389/fphar.2020.540187/full |
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