Click here to close Hello! We notice that you are using Internet Explorer, which is not supported by Echinobase and may cause the site to display incorrectly. We suggest using a current version of Chrome, FireFox, or Safari.
Echinobase
ECB-ART-54129
JAMA Netw Open 2024 Oct 01;710:e2439332. doi: 10.1001/jamanetworkopen.2024.39332.
Show Gene links Show Anatomy links

Time to Sustained Recovery Among Outpatients With COVID-19 Receiving Montelukast vs Placebo: The ACTIV-6 Randomized Clinical Trial.

Rothman RL , Stewart TG , Mourad A , Boulware DR , McCarthy MW , Thicklin F , Garcia Del Sol IT , Garcia JL , Bramante CT , Shah NS , Singh U , Williamson JC , Rebolledo PA , Jagannathan P , Schwasinger-Schmidt T , Ginde AA , Castro M , Jayaweera D , Sulkowski M , Gentile N , McTigue K , Felker GM , DeLong A , Wilder R , Collins S , Dunsmore SE , Adam SJ , Hanna GJ , Shenkman E , Hernandez AF , Naggie S , Lindsell CJ , Accelerating COVID-19 Therapeutic Interventions and Vaccines–6 Study Group and Investigators .


???displayArticle.abstract???
IMPORTANCE: The effect of montelukast in reducing symptom duration among outpatients with mild to moderate COVID-19 is uncertain. OBJECTIVE: To assess the effectiveness of montelukast compared with placebo in treating outpatients with mild to moderate COVID-19. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial (Accelerating COVID-19 Therapeutic Interventions and Vaccines [ACTIV]-6) was conducted from January 27 through June 23, 2023, during the circulation of Omicron subvariants. Participants aged 30 years or older with confirmed SARS-CoV-2 infection and 2 or more acute COVID-19 symptoms for less than 7 days were included across 104 US sites. INTERVENTIONS: Participants were randomized 1:1 to receive montelukast, 10 mg once daily, or matched placebo for 14 days. MAIN OUTCOMES AND MEASURES: The primary outcome was time to sustained recovery (defined as ≥3 consecutive days without symptoms). Secondary outcomes included time to death; time to hospitalization or death; a composite of health care utilization events (hospitalization, urgent care clinic visit, emergency department visit, or death); COVID-19 clinical progression scale score; and difference in mean time unwell. A modified intention-to-treat approach was used for the analysis. RESULTS: Among 1250 participants who were randomized and received the study drug or placebo, the median age was 53 years (IQR, 42-62 years), 753 (60.2%) were female, and 704 (56.3%) reported receiving 2 or more doses of a SARS-CoV-2 vaccine. Among 628 participants who received montelukast and 622 who received placebo, differences in time to sustained recovery were not observed (adjusted hazard ratio [AHR], 1.02; 95% credible interval [CrI], 0.92-1.12; P = .63 for efficacy). Unadjusted median time to sustained recovery was 10 days (95% CI, 10-11 days) in both groups. No deaths occurred, and hospitalizations were reported for 2 participants (0.3%) in each group; the composite of health care utilization events was reported for 18 participants (2.9%) in the montelukast group and 18 (2.9%) in the placebo group (AHR, 1.01; 95% CrI, 0.45-1.84; P = .48 for efficacy). Five participants (0.4%) experienced serious adverse events (3 [0.5%] in the montelukast group and 2 [0.3%] in the placebo group). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of outpatients with mild to moderate COVID-19, treatment with montelukast did not reduce duration of COVID-19 symptoms. These findings do not support the use of montelukast for the treatment of mild to moderate COVID-19. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04885530.

???displayArticle.pubmedLink??? 39422912
???displayArticle.link??? JAMA Netw Open
???displayArticle.grants??? [+]