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Coronavirus Disease 2019 Related Clinical Studies: A Cross-Sectional Analysis

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-...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7492524/
https://www.ncbi.nlm.nih.gov/pubmed/32982751
http://dx.doi.org/10.3389/fphar.2020.540187
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author 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
author_facet 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
author_sort Ma, Lin-Lu
collection PubMed
description 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.
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spelling pubmed-74925242020-09-25 Coronavirus Disease 2019 Related Clinical Studies: A Cross-Sectional Analysis 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 Front Pharmacol Pharmacology 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. Frontiers Media S.A. 2020-09-02 /pmc/articles/PMC7492524/ /pubmed/32982751 http://dx.doi.org/10.3389/fphar.2020.540187 Text en Copyright © 2020 Ma, Yin, Li, Yang, Jin, Huang, Deng, Wang, Ren, Ji and Zeng http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
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
Coronavirus Disease 2019 Related Clinical Studies: A Cross-Sectional Analysis
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 Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7492524/
https://www.ncbi.nlm.nih.gov/pubmed/32982751
http://dx.doi.org/10.3389/fphar.2020.540187
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