Appealing for efficient, well organized clinical trials on COVID-19.

Zhao, Yang; Wei, Yongyue; Shen, Sipeng; Zhang, Mingzhi; Chen, Feng

Background The rapid emergence of clinical trials on COVID-19 stimulated a wave of discussion in scientific community. It is important to understand the characteristics of the ongoing or pending interventional clinical trials on COVID-19. Methods We reviewed the characteristics of interventional trials from Chinese Clinical Trial Registration (ChiCTR) and ClinicalTrials.gov. A total of 171 COVID-19-related interventional trials were identified on Feb 22, 2020. These trials are classified into 4 categories based on treatment modalities, including chemical drugs (CDs), biological therapies (BTs), traditional Chinese medicine (TCM) treatments and other therapies. Results Our analysis focused on the issues of stage, design, randomization, blinding, primary endpoints (PEs) definition and sample size of these trials. Although most trials use parallel-arm design (88.3%) and randomization (77.2%), blinding is applied in only 25 trials (14.6%). More than half of the trials planned to recruit ≤100 patients, indicating a possibility of insufficient statistical power. About one third of trials will recruit severe and critically ill patients. More trials on traditional Chinese medical treatment use 2 or more PEs than those on CDs or biological treatments (57.6%, 39.4% and 40.5%, respectively). Conclusions We found some studies with potential defects including unreasonable design, inappropriate PE and small sample size. Clinical trials on COVID-19 should be designed based on scientific rules, ethics and benefits for patients.