A national study coordinated by Vanderbilt University Medical Center (VUMC) and the Duke Clinical Research Institute (DCRI) has revealed that montelukast, a drug commonly used to prevent asthma attacks, does not accelerate recovery from mild to moderate COVID-19 symptoms. The findings, published in JAMA Network Open, underscore the importance of rigorous testing for repurposed drugs in the fight against COVID-19.
The randomized, controlled clinical trial, part of the NIH-funded ACTIV-6 platform, involved 1,250 outpatients experiencing acute post-COVID-19 symptoms across 104 centers in the United States between January and June 2023. Participants were randomized to receive either 10-milligram montelukast tablets or a matching placebo for 14 days. The study employed a decentralized clinical trial methodology, with medications delivered to patients' homes and data reported remotely.
The primary endpoint was the time to sustained recovery. The results indicated no significant difference in the time to sustained recovery between the montelukast and placebo groups. This suggests that montelukast does not provide a therapeutic benefit for COVID-19 in the outpatient setting.
"This randomized trial has demonstrated that montelukast does not appear to be helpful in treating COVID-19 in the outpatient setting," stated Dr. Russell Rothman, the study's first author and Ingram Professor of Integrative and Population Health at VUMC.
The Need for Effective Outpatient Treatments
Despite the shifting landscape of the COVID-19 pandemic, a significant number of individuals continue to experience symptoms, leading to missed work and reduced quality of life. This highlights the ongoing need for effective outpatient treatment options.
"The course of the COVID-19 pandemic has shifted, but we still have thousands of people getting sick, missing work, and dealing with symptoms," said Dr. Christopher Lindsell, professor and co-chief of the Division of Biostatistics and Bioinformatics at Duke University School of Medicine and director of DCRI Biostatistics. "There's a real need for better options."
ACTIV-6: A Platform for Repurposing Drugs
The ACTIV-6 platform is designed to efficiently test existing drugs for potential repurposing as COVID-19 treatments. By evaluating drugs already known to be safe and available, researchers aim to accelerate the identification of effective therapies and reduce the time and cost associated with developing new drugs. Ruling out ineffective therapies, such as montelukast in this case, allows clinical and research efforts to be focused on more promising avenues.
"ACTIV-6 has been a great partnership between VUMC and DCRI," noted Dr. Sean Collins, current principal investigator of the Data Coordinating Center at VUMC. He emphasized the extensive work and expertise behind the scenes at the Vanderbilt Coordinating Center and the Department of Biostatistics at VUMC, which contributed to the success of the ACTIV-6 initiative.
