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, Willcox Merlin L, Liu Jian-Ping
Centre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
Integr Med Res. 2020 Sep;9(3):100426. doi: 10.1016/j.imr.2020.100426. Epub 2020 May 20.
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.
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.
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.
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.
2020年3月11日，世界卫生组织将2019冠状病毒病（COVID-19）列为大流行病。许多关于COVID-19的临床试验已注册，我们旨在回顾研究特征并为未来试验提供指导，以避免重复劳动。
检索了2020年3月3日前在全球八个注册平台上注册的关于COVID-19的研究，并提取和分析了设计、参与者、干预措施和结果的数据。
共识别出393项研究，其中380项（96.7%）来自中国大陆，3项来自日本，3项来自法国，2项来自美国，3项为国际合作研究。266项（67.7%）旨在评估治疗效果，其他则用于预防、诊断、预后等。202项研究（51.4%）为随机对照试验。三分之二的治疗性研究测试了西药，包括抗病毒药物（17.7%）、干细胞和脐带血疗法（10.2%）、氯喹及其衍生物（8.3%），16项（6.0%）测试了中药，73项（27.4%）测试了中西医结合疗法。266项治疗性研究中有31项（11.7%）将死亡率作为主要结局，而最常设计的次要结局是症状和体征（47.0%）。截至3月3日，一半的研究（45.5%）尚未开始招募。
中国研究中结局设定不当、招募延迟以及新病例数量不足意味着许多研究可能无法完成。对于突发公共卫生事件，有必要制定具有强大且快速数据共享功能的研究策略和方案，以帮助及时做出基于证据的决策。
