Development and progress of clinical trials of Coronavirus Disease 2019 antiviral drugs

ABSTRACT

Introduction

We have summarized and analyzed the clinical trial registration status and the latest research progress of eight major antiviral drugs during the epidemic of Coronavirus Disease 2019 (COVID-19), which can provide reference methods for clinical formulation of the best antiviral treatment.

Areas covered

We used the generic names of 8 antiviral drugs as keywords to search and analyze the COVID-19-related clinical trials registered in Chinese Clinical Trial Registry and ClinicalTrials.gov. Then, we used the keywords to obtain and summarize their clinical research results related to COVID-19 in CNKI, WANFANG, CQVIP, and PubMed database.

Expert opinion

The registration system of clinical trials and the level of clinical trial design need to be further improved. At present, no specific drug has been found for the treatment of COVID-19, the efficacy of antiviral drugs mostly comes from small sample studies or retrospective studies, and the level of clinical evidence is low. Besides, multi-drug combination therapy may become a more effective treatment choice, but the drug interactions and adverse drug reactions also need to be closely monitored. In summary, the safety and efficacy of various antiviral drugs need to be confirmed by large samples and high-quality RCT studies.

KEYWORDS:

• Severe acute respiratory syndrome coronavirus 2
• Coronavirus Disease 2019
• clinical trials
• antiviral drugs
• pharmacotherapy

Article highlights

• In 152 registered clinical trials related to 8 antiviral drugs, RCT studies accounted for 86.8%, blind studies accounted for only 46.5%.

• In 42 articles related to clinical trial results, RCT studies accounted for only 23.8%, blind studies accounted for only 7.1%.

• The efficacy of antiviral drugs mostly comes from small sample studies or retrospective studies, and the level of clinical evidence is low.

• The multi-drug combination therapy may be a more effective treatment choice, but the drug interactions and adverse drug reactions need to be closely monitored.

• The safety and efficacy of various antiviral drugs in COVID-19 treatment need to be confirmed by larger samples and high-quality RCT studies

Declaration of interest

Z. Zhao has received research funding support from Beijing Municipal Administration of Hospitals (ZYLX201827). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

A reviewer on this manuscript has disclosed being an investigator for ISARIC, ACTT and RECOVERY trials. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This study was funded by the Beijing Municipal Administration of Hospitals (ZYLX201827).