Treatment with montelukast resulted in fewer incidents of clinical deterioration in hospitalized patients with COVID-19, suggesting that this treatment option may have clinical activity, according to study results published in the Journal of Asthma.

An accumulation of evidence suggests that excessive inflammation increases the severity of COVID-19 infection, and is associated with an increase in interleukin-6, C-reactive protein, procalcitonin, interleukin-2, interleukin-10, and tumor necrosis factor alpha levels. In studies conducted in murine models, the use of montelukast was found to decrease the release of interleukin-6 and tumor necrosis factor alpha levels, suggesting that montelukast may prevent the progression of severe lung disease in patients with COVID-19.

To determine whether the administration of montelukast would reduce clinical deterioration (as measured by the COVID-19 Ordinal Scale) in hospitalized patients with confirmed COVID-19, a team of investigators conducted a retrospective review. They also aimed to assess whether this treatment would effectively reduce inflammatory markers contributing to pulmonary function.

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A total of 92 patients were assessed: 30 patients received montelukast treatment and 62 patients did not receive montelukast treatment. Among patients who received montelukast, the median age was 67 years, 50% were men, 36.7% of patients had asthma, and 13.3% of patients were treated with azithromycin. Meanwhile, among patients who did not received montelukast, the median age was 59 years (P =.011), 61.3% were men (P =.30), 6.5% of patients had asthma as a baseline comorbidity (P =.0005), and 40.3% of patients were treated with azithromycin (P =.01).

In addition, baseline lactic acid dehydrogenase levels were lower in patients treated with montelukast compared with those who were not (P =.04). From day 1 to day 3 of hospitalization, clinical deterioration occurred significantly less frequently in patients treated with montelukast compared with those were not (P =.022).

Results from a univariate logistic regression, used to assess the link between montelukast use and clinical deterioration, suggested that there was a lower risk of clinical deterioration in this patient population (odds ratio [OR], 0.23; P =.029); however, in multivariable logistic regression results accounting for patients aged 60 years or older, montelukast was not significantly associated with a reduced risk of clinical deterioration (OR, 0.28; P =.058).

“These findings suggest that montelukast may have clinical efficacy in reducing complications of COVID-19,” the investigators wrote.

“Rather than incorporation into practice without further study, we advocate for confirmatory clinical trials and additional retrospective data to support the incorporation of montelukast for the treatment of COVID-19. One such

trial appears to be ongoing, such as NCT04389411, a phase 3 trial evaluating the use of montelukast compared with placebo for COVID-19 infection,” concluded the authors.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.


Khan AR, Misdary C, Yegya-Raman N, et al. Montelukast in hospitalized patients diagnosed with COVID-19. J Asthma. Published online March 4, 2021. doi:10.1080/02770903.2021.1881967