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Characteristics of registered studies for Coronavirus disease 2019 (COVID-19): a systematic review

Integrative Medicine Research 2020년 9권 3호 p.7 ~ 7
Yang Ming, Shang Ya-Xi, Tian Zi-Yu, Xiong Min, Lu Chun-Li, Jiang Yue, Zhang Yao, Zhang Ying-Ying, Jin Xin-Yan, Jin Qiu-Bai, Zhang Ying, Jin Qiu-Bai, Liu Jian-Ping,
소속 상세정보
 ( Yang Ming ) - Beijing University of Chinese Medicine Centre for Evidence-Based Chinese Medicine
 ( Shang Ya-Xi ) - Beijing University of Chinese Medicine Centre for Evidence-Based Chinese Medicine
 ( Tian Zi-Yu ) - Beijing University of Chinese Medicine Centre for Evidence-Based Chinese Medicine
 ( Xiong Min ) - Beijing University of Chinese Medicine Centre for Evidence-Based Chinese Medicine
 ( Lu Chun-Li ) - Beijing University of Chinese Medicine Centre for Evidence-Based Chinese Medicine
 ( Jiang Yue ) - Beijing University of Chinese Medicine Centre for Evidence-Based Chinese Medicine
 ( Zhang Yao ) - Beijing University of Chinese Medicine School of Traditional Chinese Medicine
 ( Zhang Ying-Ying ) - Beijing University of Chinese Medicine Centre for Evidence-Based Chinese Medicine
 ( Jin Xin-Yan ) - Beijing University of Chinese Medicine Third Affiliated Hospital
 ( Jin Qiu-Bai ) - Beijing University of Chinese Medicine Dongzhimen Hospital
 ( Zhang Ying ) - Beijing University of Chinese Medicine Centre for Evidence-Based Chinese Medicine
 ( Jin Qiu-Bai ) - University of Southampton Aldermoor Health Centre School of Primary Care, Population Sciences and Medical Education
 ( Liu Jian-Ping ) - Beijing University of Chinese Medicine Centre for Evidence-Based Chinese Medicine

Abstract


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.

키워드

COVID-19; Public health emergency; Therapeutic effect; Trial characteristics; Trial registration

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