A drug commonly used to prevent asthma attacks does not speed recovery from symptoms of mild to moderate COVID-19, a national study coordinated by Vanderbilt University Medical Center and the Duke Clinical Research Institute (DCRI) has found.
The study was part of the National Institutes of Health Accelerating Coronavirus Disease 2019 Therapeutic Interventions and Vaccines (ACTIV-6) platform, which is testing whether existing drugs can be “repurposed” to treat COVID-19 in the outpatient setting. VUMC is the platform’s Data Coordinating Center and DCRI is the Clinical Coordinating Center.
Montelukast, which is prescribed to prevent and treat asthma and exercise-induced bronchoconstriction, has anti-inflammatory effects, and may have direct antiviral activity against SARS-CoV-2, which causes COVID-19. A few small clinical studies have suggested that it may reduce symptoms after COVID-19 virus infection.
The current study, a randomized and controlled clinical trial, tested the effectiveness of montelukast in 1,250 outpatients with acute post-COVID-19 symptoms. The study was conducted at 104 centers across the United States between January and June 2023.
Participants were randomized to 14 days of either 10-milligram montelukast tablets or matching placebo. ACTIV-6 uses decentralized clinical trial methodology, where patients receive home delivery of their medications and report their data from home, thereby avoiding the need to come to a medical center for study procedures.
The study results, published Oct. 18 in the journal JAMA Network Open, found no difference in the time to sustained recovery between the montelukast and control groups.
“This randomized trial has demonstrated that montelukast does not appear to be helpful in treating COVID-19 in the outpatient setting,” concluded the paper’s first author, Russell Rothman, MD, MPP.
Rothman, the Ingram Professor of Integrative and Population Health and Senior Vice President of Population and Public Health at VUMC, was principal investigator of the ACTIV-6 Data Coordinating Center at VUMC during this portion of the study.
Testing repurposed drugs can save time and the cost of designing new drugs, the researchers explained. Ruling out ineffective therapies helps redirect clinical and research efforts toward identifying truly effective ones.
“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 senior study author Christopher Lindsell, PhD, 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,” Lindsell said.
“ACTIV-6 has been a great partnership between VUMC and DCRI,” noted VUMC co-author Sean Collins, MD, MSc, current principal investigator of the Data Coordinating Center and a member of the ACTIV-6 Executive Committee.
Collins, a professor of Emergency Medicine and director of the Center for Emergency Care Research and Innovation, added that the success of ACTIV-6 “is a testament to the extensive amount of work and expertise behind the scenes by the Vanderbilt Coordinating Center and the Department of Biostatistics at VUMC.”
ACTIV-6 is funded by the National Center for Advancing Translational Sciences of the NIH (grant number 3U24TR001608). Additional support for this study was provided by the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, in the U.S. Department of Health and Human Services.
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