Characteristics of registered studies for Coronavirus disease 2019 (COVID-19): a systematic review
Background: The World Health Organization characterized the Coronavirus disease 2019 (COVID-19) as a pandemic on March 11th. Many clinical trials on COVID-19 have been registered, and we aim to review the study characteristics and provide guidance for future trials to avoid duplicated effort. Method...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2020-09-01
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| Series: | Integrative Medicine Research |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2213422020300585 |
| _version_ | 1818576406878093312 |
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| author | Ming Yang Ya-xi Shang Zi-yu Tian Min Xiong Chun-li Lu Yue Jiang Yao Zhang Ying-ying Zhang Xin-yan Jin Qiu-bai Jin Ying Zhang Merlin L. Willcox Jian-ping Liu |
| author_facet | Ming Yang Ya-xi Shang Zi-yu Tian Min Xiong Chun-li Lu Yue Jiang Yao Zhang Ying-ying Zhang Xin-yan Jin Qiu-bai Jin Ying Zhang Merlin L. Willcox Jian-ping Liu |
| author_sort | Ming Yang |
| collection | DOAJ |
| description | Background: The World Health Organization characterized the Coronavirus disease 2019 (COVID-19) as a pandemic on March 11th. Many clinical trials on COVID-19 have been registered, and we aim to review the study characteristics and provide guidance for future trials to avoid duplicated effort. Methods: Studies on COVID-19 registered before March 3rd, 2020 on eight registry platforms worldwide were searched and the data of design, participants, interventions, and outcomes were extracted and analyzed. Results: Three hundred and ninety-three studies were identified and 380 (96.7%) were from mainland China, while 3 in Japan, 3 in France, 2 in the US, and 3 were international collaborative studies. Two hundred and sixty-six (67.7%) aimed at therapeutic effect, others were for prevention, diagnosis, prognosis, etc. Two hundred and two studies (51.4%) were randomized controlled trials. Two third of therapeutic studies tested Western medicines including antiviral drugs (17.7%), stem cell and cord blood therapy (10.2%), chloroquine and derivatives (8.3%), 16 (6.0%) on Chinese medicines, and 73 (27.4%) on integrated therapy of Western and Chinese medicines. Thirty-one studies among 266 therapeutic studies (11.7%) used mortality as primary outcome, while the most designed secondary outcomes were symptoms and signs (47.0%). Half of the studies (45.5%) had not started recruiting till March 3rd. Conclusion: Inappropriate outcome setting, delayed recruitment and insufficient numbers of new cases in China implied many studies may fail to complete. Strategies and protocols of the studies with robust and rapid data sharing are warranted for emergency public health events, helping the timely evidence-based decision-making. |
| first_indexed | 2024-12-16T06:13:31Z |
| format | Article |
| id | doaj.art-6e0c5c08b03c477cb8b61a0830f0e6aa |
| institution | Directory Open Access Journal |
| issn | 2213-4220 |
| language | English |
| last_indexed | 2024-12-16T06:13:31Z |
| publishDate | 2020-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Integrative Medicine Research |
| spelling | doaj.art-6e0c5c08b03c477cb8b61a0830f0e6aa2022-12-21T22:41:20ZengElsevierIntegrative Medicine Research2213-42202020-09-0193100426Characteristics of registered studies for Coronavirus disease 2019 (COVID-19): a systematic reviewMing Yang0Ya-xi Shang1Zi-yu Tian2Min Xiong3Chun-li Lu4Yue Jiang5Yao Zhang6Ying-ying Zhang7Xin-yan Jin8Qiu-bai Jin9Ying Zhang10Merlin L. Willcox11Jian-ping Liu12Centre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaCentre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaCentre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China; Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, ChinaCentre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China; Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, ChinaCentre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China; Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China; School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China; Third Affiliated Hospital, Beijing University of Chinese Medicine, Beijing, China; School of Primary Care, Population Sciences and Medical Education, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, United Kingdom; Institute of Integrated Traditional Chinese Medicine and Western Medicine, Guangzhou Medical University, Guangzhou, ChinaCentre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China; Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China; School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China; Third Affiliated Hospital, Beijing University of Chinese Medicine, Beijing, China; School of Primary Care, Population Sciences and Medical Education, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, United Kingdom; Institute of Integrated Traditional Chinese Medicine and Western Medicine, Guangzhou Medical University, Guangzhou, ChinaSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaCentre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaThird Affiliated Hospital, Beijing University of Chinese Medicine, Beijing, ChinaDongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, ChinaCentre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaSchool of Primary Care, Population Sciences and Medical Education, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, United KingdomCentre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China; Institute of Integrated Traditional Chinese Medicine and Western Medicine, Guangzhou Medical University, Guangzhou, China; Corresponding author at: Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, 11 Bei San Huan Dong Lu, Chaoyang District, Beijing 100029, China.Background: The World Health Organization characterized the Coronavirus disease 2019 (COVID-19) as a pandemic on March 11th. Many clinical trials on COVID-19 have been registered, and we aim to review the study characteristics and provide guidance for future trials to avoid duplicated effort. Methods: Studies on COVID-19 registered before March 3rd, 2020 on eight registry platforms worldwide were searched and the data of design, participants, interventions, and outcomes were extracted and analyzed. Results: Three hundred and ninety-three studies were identified and 380 (96.7%) were from mainland China, while 3 in Japan, 3 in France, 2 in the US, and 3 were international collaborative studies. Two hundred and sixty-six (67.7%) aimed at therapeutic effect, others were for prevention, diagnosis, prognosis, etc. Two hundred and two studies (51.4%) were randomized controlled trials. Two third of therapeutic studies tested Western medicines including antiviral drugs (17.7%), stem cell and cord blood therapy (10.2%), chloroquine and derivatives (8.3%), 16 (6.0%) on Chinese medicines, and 73 (27.4%) on integrated therapy of Western and Chinese medicines. Thirty-one studies among 266 therapeutic studies (11.7%) used mortality as primary outcome, while the most designed secondary outcomes were symptoms and signs (47.0%). Half of the studies (45.5%) had not started recruiting till March 3rd. Conclusion: Inappropriate outcome setting, delayed recruitment and insufficient numbers of new cases in China implied many studies may fail to complete. Strategies and protocols of the studies with robust and rapid data sharing are warranted for emergency public health events, helping the timely evidence-based decision-making.http://www.sciencedirect.com/science/article/pii/S2213422020300585COVID-19Public health emergencyTherapeutic effectTrial characteristicsTrial registration |
| spellingShingle | Ming Yang Ya-xi Shang Zi-yu Tian Min Xiong Chun-li Lu Yue Jiang Yao Zhang Ying-ying Zhang Xin-yan Jin Qiu-bai Jin Ying Zhang Merlin L. Willcox Jian-ping Liu Characteristics of registered studies for Coronavirus disease 2019 (COVID-19): a systematic review Integrative Medicine Research COVID-19 Public health emergency Therapeutic effect Trial characteristics Trial registration |
| title | Characteristics of registered studies for Coronavirus disease 2019 (COVID-19): a systematic review |
| title_full | Characteristics of registered studies for Coronavirus disease 2019 (COVID-19): a systematic review |
| title_fullStr | Characteristics of registered studies for Coronavirus disease 2019 (COVID-19): a systematic review |
| title_full_unstemmed | Characteristics of registered studies for Coronavirus disease 2019 (COVID-19): a systematic review |
| title_short | Characteristics of registered studies for Coronavirus disease 2019 (COVID-19): a systematic review |
| title_sort | characteristics of registered studies for coronavirus disease 2019 covid 19 a systematic review |
| topic | COVID-19 Public health emergency Therapeutic effect Trial characteristics Trial registration |
| url | http://www.sciencedirect.com/science/article/pii/S2213422020300585 |
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