Drug Design, Development and Therapy (Nov 2020)
COVID-19 Clinical Trials Registered Worldwide for Drug Intervention: An Overview and Characteristic Analysis
Abstract
Bin Wang,1 Junkai Lai,1 Xiaoyan Yan,2 Feifei Jin,1 Bin Yi,3 Caixia An,3 Yuanxiao Li,4 Chen Yao1,2 1Department of Biostatistics, Peking University First Hospital, Beijing, People’s Republic of China; 2Peking University Clinical Research Institute, Beijing, People’s Republic of China; 3Children’s Emergency Center, Gansu Provincial Maternity and Child-Care Hospital, Lanzhou, People’s Republic of China; 4Department of Pediatric Gastroenterology, Second Hospital of Lanzhou University, Lanzhou, People’s Republic of ChinaCorrespondence: Chen YaoPeking University First Hospital, Xicheng District, Beijing 100034, People’s Republic of ChinaTel +86 18610640562Email [email protected]: This study aims to comprehensively evaluate the characteristics of clinical drug trials to facilitate the collection of evidence for COVID-19 drug treatments.Methods: A retrospective analysis of 910 trials retrieved on August 7, 2020.Results: A total of 910 registered clinical trials with at least one drug intervention were evaluated. The number of registrations (32.4%, 295) from the United States accounted for nearly one-third of the total and far exceeded that of other countries individually. Furthermore, the peak number of trials were registered in April (34.3%, 312). Over half of the trials (51.2%, 466) are in the recruitment phase, and only 4.2% (38) of the trials have been completed. The median (interquartile range) estimated enrollment is 127 (59, 365). In 39% (355) of trials, the estimated enrollment is less than 100 participants. A total of 94.5% (790) of the trials use randomization in the allocation, 82.7% (753) use a parallel intervention mode, and 52.2% (475) use masking. A total of 287 drug names have been standardized and mapped. “Hydroxychloroquine” is the leading drug among the registered trials (7.47%, 68). Among the main countries contributing to investigations on “hydroxychloroquine”, the United States ranks first with 36.76% (25) of the trials.Conclusion: The designs of COVID-19 clinical drug trials have greatly improved in terms of the implementation of randomization and, particularly, blinding methods. In terms of drug reuse, the number of drug types has greatly increased, and hundreds of drugs have been used for efficacy screening. The emergence of large-sample registration trials is expected to address the uncertainty regarding the current clinical efficacy of some drugs.Keywords: COVID-19, clinical trials, investigation, intervention, drug, treatment
