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

Autor:	Rothman RL; Vanderbilt University Medical Center, Nashville, Tennessee., Stewart TG; School of Data Science, University of Virginia, Charlottesville., Mourad A; Department of Medicine, Duke University School of Medicine, Durham, North Carolina.; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina., Boulware DR; Department of Medicine, University of Minnesota Medical School, Minneapolis., McCarthy MW; Weill Cornell Medicine, New York, New York., Thicklin F; ACTIV-6 Stakeholder Advisory Committee, Pittsburgh, Pennsylvania., Garcia Del Sol IT; L&A Morales Healthcare, Inc, Hialeah, Florida., Garcia JL; The Angel Medical Research Corporation, Miami Lakes, Florida., Bramante CT; Department of Medicine, University of Minnesota Medical School, Minneapolis., Shah NS; Endeavor Health, Evanston, Illinois., Singh U; Stanford University School of Medicine, California., Williamson JC; Section on Infectious Diseases, Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina., Rebolledo PA; Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.; Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, Georgia., Jagannathan P; Stanford University School of Medicine, California., Schwasinger-Schmidt T; Center for Clinical Research, University of Kansas School of Medicine-Wichita., Ginde AA; University of Colorado School of Medicine, Aurora., Castro M; Division of Pulmonary, Critical Care and Sleep Medicine, University of Kansas Medical Center, Kansas City., Jayaweera D; Department of Medicine, Miller School of Medicine, University of Miami, Miami, Florida., Sulkowski M; Division of Infectious Diseases, Johns Hopkins University, Baltimore, Maryland., Gentile N; Department of Emergency Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania., McTigue K; Department of Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania., Felker GM; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.; Department of Medicine, University of Minnesota Medical School, Minneapolis., DeLong A; Department of Medicine, University of Minnesota Medical School, Minneapolis., Wilder R; Department of Medicine, University of Minnesota Medical School, Minneapolis., Collins S; Vanderbilt University Medical Center, Nashville, Tennessee.; Geriatric Research Education and Clinical Center, Veterans Affairs Tennessee Valley Healthcare System, Nashville., Dunsmore SE; National Center for Advancing Translational Sciences, Bethesda, Maryland., Adam SJ; Foundation for the National Institutes of Health, Bethesda, Maryland., Hanna GJ; Biomedical Advanced Research and Development Authority, Washington, DC., Shenkman E; Department of Health Outcomes & Biomedical Informatics, College of Medicine, University of Florida, Gainesville., Hernandez AF; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.; Department of Medicine, University of Minnesota Medical School, Minneapolis., Naggie S; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.; Department of Medicine, University of Minnesota Medical School, Minneapolis., Lindsell CJ; Department of Medicine, University of Minnesota Medical School, Minneapolis.
Jazyk:	angličtina
Zdroj:	JAMA network open [JAMA Netw Open] 2024 Oct 01; Vol. 7 (10), pp. e2439332. Date of Electronic Publication: 2024 Oct 01.
DOI:	10.1001/jamanetworkopen.2024.39332
Abstrakt:	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.
Databáze:	MEDLINE
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