Post by Nadica (She/Her) on Oct 22, 2024 3:05:48 GMT
Asthma Drug Shows No Benefit for Mild to Moderate COVID-19 - Published Oct 21, 2024
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 has found.
Montelukast, which is prescribed to prevent and treat asthma and exercise-induced bronchoconstriction, has anti-inflammatory effects and may have direct anti-viral activity against SARS-CoV-2. A few small clinical studies have suggested that it may reduce symptoms after COVID-19 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.
The study was part of the Accelerating Coronavirus Disease 2019 Therapeutic Interventions and Vaccines (ACTIV-6) platform of investigations supported by the National Institutes of Health (NIH) to test whether existing drugs can be “repurposed” to treat COVID-19 infection in the outpatient setting.
VUMC is the platform’s Data Coordinating Center and Duke is the Clinical Coordinating Center.
Participants were randomly selected to receive by home delivery a 14-day supply of either 10-milligram montelukast tablets or matching placebo pills. The study, which was published Oct. 18 in the journal JAMA Network Open, found no difference in the time to sustained recovery between the montelukast and control groups.
“When we started this trial to test montelukast we really did not know if it would be beneficial or not in treating outpatient COVID-19,” said the paper’s first author Russell Rothman, MD, MPP, the Ingram Professor of Integrative and Population Health and Senior Vice President of Population and Public Health at VUMC.
“This randomized trial has demonstrated that montelukast does not appear to be helpful in treating COVID-19 in the outpatient setting,” he said.
VUMC co-author Sean Collins , MD, MSc, is Professor of Emergency Medicine and director of the Center for Emergency Care Research and Innovation.
Although the drug was generally well-tolerated in the trial, researchers emphasized the importance of negative results.
“Knowing that a treatment doesn’t work is as crucial as knowing it does,” 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 Data Science and Biostatistics. “It prevents unnecessary use and potential harm.”
The findings underscore the ongoing challenges in identifying effective COVID-19 therapies for those managing the virus at home rather than in the hospital. While several antiviral drugs have emerged for hospitalized patients, treatments for those experiencing milder symptoms remain limited.
“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 Lindsell. “There’s a real need for better options.”
ACTIV-6 is funded by the National Center for Advancing Translational Sciences of the National Institutes of Health (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, part of the U.S. Department of Health and Human Services.
“Testing repurposed medications for COVID-19 is important because these drugs are already on the market and more readily available than trying to design new drugs,” Rothman explained. “These drugs have been previously tested for safety and efficacy in other conditions, and these drugs may already be used off-label to try to treat COVID-19.”
The ACTIV-6 platform has supported studies of three other drugs with repurposing potential that have been found not to reduce “time to recovery” from various symptoms of COVID-19. They are:
Ivermectin, an antiparasitic drug with possible antiviral activity;
Fluvoxamine, a selective serotonin reuptake inhibitor (SSRI) used to treat a variety of psychiatric conditions including depression; and
Fluticasone furoate, an inhaled glucocorticoid used to treat nasal inflammation and stuffiness.
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 has found.
Montelukast, which is prescribed to prevent and treat asthma and exercise-induced bronchoconstriction, has anti-inflammatory effects and may have direct anti-viral activity against SARS-CoV-2. A few small clinical studies have suggested that it may reduce symptoms after COVID-19 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.
The study was part of the Accelerating Coronavirus Disease 2019 Therapeutic Interventions and Vaccines (ACTIV-6) platform of investigations supported by the National Institutes of Health (NIH) to test whether existing drugs can be “repurposed” to treat COVID-19 infection in the outpatient setting.
VUMC is the platform’s Data Coordinating Center and Duke is the Clinical Coordinating Center.
Participants were randomly selected to receive by home delivery a 14-day supply of either 10-milligram montelukast tablets or matching placebo pills. The study, which was published Oct. 18 in the journal JAMA Network Open, found no difference in the time to sustained recovery between the montelukast and control groups.
“When we started this trial to test montelukast we really did not know if it would be beneficial or not in treating outpatient COVID-19,” said the paper’s first author Russell Rothman, MD, MPP, the Ingram Professor of Integrative and Population Health and Senior Vice President of Population and Public Health at VUMC.
“This randomized trial has demonstrated that montelukast does not appear to be helpful in treating COVID-19 in the outpatient setting,” he said.
VUMC co-author Sean Collins , MD, MSc, is Professor of Emergency Medicine and director of the Center for Emergency Care Research and Innovation.
Although the drug was generally well-tolerated in the trial, researchers emphasized the importance of negative results.
“Knowing that a treatment doesn’t work is as crucial as knowing it does,” 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 Data Science and Biostatistics. “It prevents unnecessary use and potential harm.”
The findings underscore the ongoing challenges in identifying effective COVID-19 therapies for those managing the virus at home rather than in the hospital. While several antiviral drugs have emerged for hospitalized patients, treatments for those experiencing milder symptoms remain limited.
“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 Lindsell. “There’s a real need for better options.”
ACTIV-6 is funded by the National Center for Advancing Translational Sciences of the National Institutes of Health (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, part of the U.S. Department of Health and Human Services.
“Testing repurposed medications for COVID-19 is important because these drugs are already on the market and more readily available than trying to design new drugs,” Rothman explained. “These drugs have been previously tested for safety and efficacy in other conditions, and these drugs may already be used off-label to try to treat COVID-19.”
The ACTIV-6 platform has supported studies of three other drugs with repurposing potential that have been found not to reduce “time to recovery” from various symptoms of COVID-19. They are:
Ivermectin, an antiparasitic drug with possible antiviral activity;
Fluvoxamine, a selective serotonin reuptake inhibitor (SSRI) used to treat a variety of psychiatric conditions including depression; and
Fluticasone furoate, an inhaled glucocorticoid used to treat nasal inflammation and stuffiness.