Vanderbilt University Medical Center, Nashville, Tennessee.
School of Data Science, University of Virginia, Charlottesville.
JAMA Netw Open. 2024 Oct 1;7(10):e2439332. doi: 10.1001/jamanetworkopen.2024.39332.
The effect of montelukast in reducing symptom duration among outpatients with mild to moderate COVID-19 is uncertain.
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.
Participants were randomized 1:1 to receive montelukast, 10 mg once daily, or matched placebo for 14 days.
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.
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).
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.
ClinicalTrials.gov Identifier: NCT04885530.
孟鲁司特在缩短轻度至中度 COVID-19 门诊患者症状持续时间方面的效果尚不确定。
评估孟鲁司特与安慰剂相比在治疗轻度至中度 COVID-19 门诊患者方面的疗效。
设计、地点和参与者：这项随机临床试验（Accelerating COVID-19 Therapeutic Interventions and Vaccines [ACTIV]-6）于 2023 年 1 月 27 日至 6 月 23 日进行，在此期间，奥密克戎亚变体正在传播。在美国 104 个地点纳入了年龄在 30 岁及以上、确诊 SARS-CoV-2 感染且有 2 种或以上急性 COVID-19 症状且持续时间不到 7 天的参与者。
参与者以 1:1 的比例随机接受孟鲁司特，每日 10 mg，或匹配的安慰剂治疗 14 天。
主要结局为持续康复的时间（定义为≥连续 3 天无症状）。次要结局包括死亡时间；住院或死亡时间；医疗保健利用事件的综合（住院、紧急护理诊所就诊、急诊就诊或死亡）；COVID-19 临床进展量表评分；以及平均不适时间的差异。采用改良意向治疗方法进行分析。
在 1250 名随机接受研究药物或安慰剂的参与者中，中位年龄为 53 岁（IQR，42-62 岁），753 名（60.2%）为女性，704 名（56.3%）报告接受了 2 剂或更多剂 SARS-CoV-2 疫苗。在 628 名接受孟鲁司特和 622 名接受安慰剂的参与者中，未观察到持续康复时间的差异（调整后的危险比 [AHR]，1.02；95%可信区间 [CrI]，0.92-1.12；P=0.63 用于疗效）。两组未调整的中位持续康复时间均为 10 天（95% CI，10-11 天）。没有死亡发生，每组各有 2 名（0.3%）参与者住院；医疗保健利用事件的综合在孟鲁司特组有 18 名（2.9%）和安慰剂组有 18 名（2.9%）参与者报告（AHR，1.01；95% CrI，0.45-1.84；P=0.48 用于疗效）。有 5 名（0.4%）参与者发生严重不良事件（孟鲁司特组 3 名[0.5%]，安慰剂组 2 名[0.3%]）。
在这项针对轻度至中度 COVID-19 门诊患者的随机临床试验中，孟鲁司特治疗并未缩短 COVID-19 症状的持续时间。这些发现不支持使用孟鲁司特治疗轻度至中度 COVID-19。
ClinicalTrials.gov 标识符：NCT04885530。
