tetano
Editor, Senior Moderator
JAMA Netw Open
. 2024 Oct 1;7(10):e2439332.
doi: 10.1001/jamanetworkopen.2024.39332. Time to Sustained Recovery Among Outpatients With COVID-19 Receiving Montelukast vs Placebo: The ACTIV-6 Randomized Clinical Trial
Russell L Rothman[SUP] 1 [/SUP], Thomas G Stewart[SUP] 2 [/SUP], Ahmad Mourad[SUP] 3 4 [/SUP], David R Boulware[SUP] 5 [/SUP], Matthew W McCarthy[SUP] 6 [/SUP], Florence Thicklin[SUP] 7 [/SUP], Idania T Garcia Del Sol[SUP] 8 [/SUP], Jose Luis Garcia[SUP] 9 [/SUP], Carolyn T Bramante[SUP] 5 [/SUP], Nirav S Shah[SUP] 10 [/SUP], Upinder Singh[SUP] 11 [/SUP], John C Williamson[SUP] 12 [/SUP], Paulina A Rebolledo[SUP] 13 14 [/SUP], Prasanna Jagannathan[SUP] 11 [/SUP], Tiffany Schwasinger-Schmidt[SUP] 15 [/SUP], Adit A Ginde[SUP] 16 [/SUP], Mario Castro[SUP] 17 [/SUP], Dushyantha Jayaweera[SUP] 18 [/SUP], Mark Sulkowski[SUP] 19 [/SUP], Nina Gentile[SUP] 20 [/SUP], Kathleen McTigue[SUP] 21 [/SUP], G Michael Felker[SUP] 4 5 [/SUP], Allison DeLong[SUP] 5 [/SUP], Rhonda Wilder[SUP] 5 [/SUP], Sean Collins[SUP] 1 22 [/SUP], Sarah E Dunsmore[SUP] 23 [/SUP], Stacey J Adam[SUP] 24 [/SUP], George J Hanna[SUP] 25 [/SUP], Elizabeth Shenkman[SUP] 26 [/SUP], Adrian F Hernandez[SUP] 4 5 [/SUP], Susanna Naggie[SUP] 4 5 [/SUP], Christopher J Lindsell[SUP] 5 [/SUP]; Accelerating COVID-19 Therapeutic Interventions and Vaccines–6 Study Group and Investigators
Collaborators, Affiliations
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.
. 2024 Oct 1;7(10):e2439332.
doi: 10.1001/jamanetworkopen.2024.39332. Time to Sustained Recovery Among Outpatients With COVID-19 Receiving Montelukast vs Placebo: The ACTIV-6 Randomized Clinical Trial
Russell L Rothman[SUP] 1 [/SUP], Thomas G Stewart[SUP] 2 [/SUP], Ahmad Mourad[SUP] 3 4 [/SUP], David R Boulware[SUP] 5 [/SUP], Matthew W McCarthy[SUP] 6 [/SUP], Florence Thicklin[SUP] 7 [/SUP], Idania T Garcia Del Sol[SUP] 8 [/SUP], Jose Luis Garcia[SUP] 9 [/SUP], Carolyn T Bramante[SUP] 5 [/SUP], Nirav S Shah[SUP] 10 [/SUP], Upinder Singh[SUP] 11 [/SUP], John C Williamson[SUP] 12 [/SUP], Paulina A Rebolledo[SUP] 13 14 [/SUP], Prasanna Jagannathan[SUP] 11 [/SUP], Tiffany Schwasinger-Schmidt[SUP] 15 [/SUP], Adit A Ginde[SUP] 16 [/SUP], Mario Castro[SUP] 17 [/SUP], Dushyantha Jayaweera[SUP] 18 [/SUP], Mark Sulkowski[SUP] 19 [/SUP], Nina Gentile[SUP] 20 [/SUP], Kathleen McTigue[SUP] 21 [/SUP], G Michael Felker[SUP] 4 5 [/SUP], Allison DeLong[SUP] 5 [/SUP], Rhonda Wilder[SUP] 5 [/SUP], Sean Collins[SUP] 1 22 [/SUP], Sarah E Dunsmore[SUP] 23 [/SUP], Stacey J Adam[SUP] 24 [/SUP], George J Hanna[SUP] 25 [/SUP], Elizabeth Shenkman[SUP] 26 [/SUP], Adrian F Hernandez[SUP] 4 5 [/SUP], Susanna Naggie[SUP] 4 5 [/SUP], Christopher J Lindsell[SUP] 5 [/SUP]; Accelerating COVID-19 Therapeutic Interventions and Vaccines–6 Study Group and Investigators
Collaborators, Affiliations
- PMID: 39422912
- DOI: 10.1001/jamanetworkopen.2024.39332
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.