A NEW clinical trial has found that the asthma drug montelukast does not shorten the duration of symptoms for mild-to-moderate COVID-19 patients compared to a placebo.
The study, part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-6) initiative, was conducted across 104 USA sites between January–June 2023, a period marked by the prevalence of Omicron subvariants. A total of 1,20 adults aged ≥30 years, confirmed to have COVID-19, and experiencing symptoms for less than 7 days were enrolled.
Participants were randomly assigned to either receive a 14-day course of montelukast at 10 mg daily or a placebo. The primary goal was to determine the time to sustained recovery, defined as 3 consecutive days without symptoms. Secondary outcomes included tracking hospitalisations, mortality, healthcare visits, and overall illness progression.
In both the montelukast and placebo groups, the unadjusted median time to sustained recovery was 10 days, with an adjusted hazard ratio (AHR) of 1.02 (95% credible interval [CrI]: 0.92–1.12; P=0.63), indicating no statistical difference in symptom duration. Additionally, 56.3% of the participants had received two or more COVID-19 vaccine doses.
In both groups, there were no reported deaths, and hospitalisation was rare, with just two cases (0.3%) in each group. Eighteen participants (2.9%) in both groups experienced a composite of healthcare utilisation events, such as emergency or urgent care visits (AHR: 1.01; 95% CrI: 0.45–1.84; P=0.48). Serious adverse events occurred in five participants overall: three (0.5%) in the montelukast group and two (0.3%) in the placebo group.
Researchers concluded that montelukast does not effectively reduce COVID-19 symptoms in mild to moderate cases, emphasising that current evidence does not support its use for this purpose. There is an ongoing need to identify and test alternative outpatient COVID-19 treatments.
Reference
Rothman RL et al. Time to sustained recovery among outpatients with COVID-19 receiving montelukast vs placebo: the ACTIV-6 randomized clinical trial. JAMA Netw Open. 2024;7(10):e2439332.
