Clinical Research and Data Center, South China Research Center for Acupuncture and Moxibustion, Medical College of Acu-Moxi and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.
Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.
BMC Med. 2020 Jun 1;18(1):167. doi: 10.1186/s12916-020-01612-y.
This article aims to summarize the key characteristics of registered trials of 2019 novel coronavirus (COVID-19), in terms of their spatial and temporal distributions, types of design and interventions, and patient characteristics among others.
A comprehensive search of the registered COVID-19 trials has been performed on platforms including ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (WHO ICTRP), Chinese Clinical Trials Registry (CHiCTR), Australian Clinical Trials Registry, Britain's National Research Register (BNRR), Current Control Trials (CCT), and Glaxo Smith Kline Register. Trials registered at the first 8 weeks of the COVID-19 outbreak are included, without language restrictions. For each study, the registration information, study design, and administrator information are collected and summarized.
A total of 220 registered trials were evaluated as of February 27, 2020. Hospital-initiated trials were the majority and account for 80% of the sample. Among the trials, pilot studies and phase 4 trials are more common and represent 35% and 19.1% of the sample, respectively. The median sample size of the registered trials is 100, with interquartile range 60-240. Further, 45.9% of the trials mentioned information on a data monitoring committee. 54.5% of the trials did not specify the disease severity among patients they intend to recruit. Four types of interventions are most common in the experimental groups across the registered studies: antiviral drugs, Traditional Chinese Medicine (TCM), biological agents, and hormone drugs. Among them, the TCM and biological agents are frequently used in pilot study and correspond to a variety of primary endpoints. In contrast, trials with antiviral drugs have more targeted primary outcomes such as "COVID-19 nucleic acid test" and "28-day mortality."
We provide an evidence mapping and analysis of registered COVID-19 clinical trials in China. In particular, it is critical for ongoing and future studies to refine their research hypothesis and better identify their intervention therapies and the corresponding primary outcomes. It is also imperative for multiple public health divisions and research institutions to work together for integrative clinical data capture and sharing, with a common objective of improving future studies that evaluate COVID-19 interventions.
本研究旨在总结 2019 年新型冠状病毒（COVID-19）注册试验的关键特征，包括时空分布、设计和干预类型以及患者特征等方面。
在包括 ClinicalTrials.gov、世界卫生组织国际临床试验注册平台（WHO ICTRP）、中国临床试验注册中心（CHiCTR）、澳大利亚临床试验注册处、英国国家研究注册处（BNRR）、当前对照试验（CCT）和葛兰素史克注册处在内的平台上，对 COVID-19 注册试验进行了全面检索。纳入了 COVID-19 爆发的前 8 周内注册的试验，不限制语言。对于每个研究，收集并总结其注册信息、研究设计和管理员信息。
截至 2020 年 2 月 27 日，共评估了 220 项注册试验。医院发起的试验占多数，占样本的 80%。在这些试验中，试验设计和阶段 4 试验更为常见，分别占样本的 35%和 19.1%。注册试验的中位数样本量为 100，四分位间距为 60-240。此外，45.9%的试验提到了数据监测委员会的信息。54.5%的试验没有说明他们计划招募的患者的疾病严重程度。在注册研究的实验组中，最常见的干预措施有 4 种类型：抗病毒药物、中药（TCM）、生物制剂和激素药物。其中，中药和生物制剂在试验设计中应用广泛，对应多种主要终点。相比之下，使用抗病毒药物的试验具有更有针对性的主要结局，如“COVID-19 核酸检测”和“28 天死亡率”。
本研究提供了中国 COVID-19 临床试验注册的证据图谱和分析。特别是，对于正在进行和未来的研究，细化研究假设、更好地确定干预疗法和相应的主要结局至关重要。公共卫生部门和研究机构之间也需要共同努力，进行综合临床数据采集和共享，以共同目标来改善评估 COVID-19 干预措施的未来研究。
