Study Design Characteristics and Pharmacological Mechanisms in International Clinical Trials Registry Platform: Registered Clinical Trials on Antiviral Drugs for COVID-19

Abstract

Objective

This study aimed to evaluate the pharmacological mechanisms of antiviral drugs against the novel coronavirus disease (COVID-19) and the study designs in clinical trials registered with the International Clinical Trials Registry Platform (ICTRP).

Methods

Clinical trials involving antiviral drugs for treating COVID-19 were retrieved from the ICTRP database. For each trial, the study design, number of participants, primary endpoints, source register, antiviral mechanism, and results were evaluated.

Results

On June 10, 2020, 145 eligible clinical trials were retrieved from the ICTRP, of which 99 (68.3%) were randomized trials, 109 (75.2%) were parallel assignment trials, 38 (26.2%) were double or single blinded, 130 (89.7%) involved two groups, and 75 (51.6%) included more than 100 participants; and clinical improvement or recovery and virus-negative conversion were the two most common endpoints, accounting for 40.7% and 18.6%, respectively. The drugs were divided according to the antiviral mechanism into HIV reverse transcriptase inhibitors, RNA-dependent RNA polymerase inhibitors, HIV protease inhibitors (PIs), hepatitis C virus NS3 PIs, and anti-influenza drugs.

Conclusion

The design characteristics of clinical trials of antiviral drugs for treating COVID-19 as well as the mechanism of action and antiviral efficacy of the drugs were evaluated in this study. The results of these trials could constitute a reference for future clinical trials to be executed on COVID-19 treatment and prevention.

Keywords:

• COVID-19
• clinical trials as topic
• antiviral agents
• research design

Acknowledgments

We would like to thank all investigators who registered for clinical trials and the subjects who participated in these clinical trials. This study was supported by the Shanghai scientific and technological innovation action plan in 2017 (17401970900).

Abbreviations

ANZCTR, Australian New Zealand Clinical Trials Registry; ReBec, Brazilian Clinical Trials Registry; ChiCTR, Chinese Clinical Trial Register; CRiS, Clinical Research Information Service; ClinicalTrials.gov, ClinicalTrials.gov; CTRI, Clinical Trials Registry - India; RPCEC, Cuban Public Registry of Clinical Trials; EUCTR, EU Clinical Trials Register; DRKS, German Clinical Trials Register; IRCT, Iranian Registry of Clinical Trials; ISRCTN, International Standard Randomized Controlled Trial Number; JPRN, Japan Primary Registries Network; PACTR, Pan African Clinical Trial Registry; REPEC, Peruvian Clinical Trials Registry; SLCTR, Sri Lanka Clinical Trials Registry; TCTR, Thai Clinical Trials Register; NTR, The Netherlands National Trial Register.

Data Sharing Statement

Publicly available datasets were analyzed in this study. This data can be found here: http://apps.who.int/trialsearch.

Disclosure

All authors declare no conflicts of interest in this work.