ACTIV-6 (montelukast)
Trial question
What is the role of montelukast in outpatients with mild-to-moderate COVID-19?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
60.0% female
40.0% male
N = 1250
1250 patients (753 female, 497 male).
Inclusion criteria: outpatients with mild-to-moderate COVID-19.
Key exclusion criteria: current or recent hospitalization for COVID-19; ongoing or planned participation in other interventional trials for COVID-19; current or recent use of, known allergy or sensitivity to, or contraindication to montelukast.
Interventions
N=628 montelukast (oral dose of 10 mg once daily for 14 days).
N=622 placebo (matching placebo once daily for 14 days).
Primary outcome
Median time to sustained recovery
10 days
10 days
10.0 days
7.5 days
5.0 days
2.5 days
0.0 days
Montelukast
Placebo
No significant
difference ↔
No significant difference in median time to sustained recovery (10 days vs. 10 days; HR 1.02, 95% CI -2.98 to 5.02).
Secondary outcomes
No significant difference in the rate of hospitalization, urgent care, emergency department visit, or death through day 28 (2.87% vs. 2.89%; HR 1.01, 95% CI -1.73 to 3.75).
No significant difference in clinical progression ordinal outcome scale at day 7 (89.8% vs. 89.6%; OR 1.31, 95% CI -1 to 3.62).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In outpatients with mild-to-moderate COVID-19, montelukast was not superior to placebo with respect to median time to sustained recovery.
Reference
Russell L Rothman, Thomas G Stewart, Ahmad Mourad 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 Oct 1;7(10):e2439332.
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