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.
Keywords: COVID-19; Clinical trials.
2020 Annals of Translational Medicine. All rights reserved.