Montelukast in hospitalized patients diagnosed with COVID-19

Ahsan R Khan,Christian Misdary,Nikhil Yegya-Raman,Sinae Kim,Navaneeth Narayanan,Sheraz Siddiqui,Padmini Salgame,Jared Radbel,Frank De Groote,Carl Michel,Janice Mehnert,Caleb Hernandez,Thomas Braciale,Jyoti Malhotra,Michael A Gentile,Salma K Jabbour

doi:10.1080/02770903.2021.1881967

Abstract

Objective Several therapeutic agents have been assessed for the treatment of COVID-19, but few approaches have been proven efficacious. Because leukotriene receptor antagonists, such as montelukast have been shown to reduce both cytokine release and lung inflammation in preclinical models of viral influenza and acute respiratory distress syndrome, we hypothesized that therapy with montelukast could be used to treat COVID-19. The objective of this study was to determine if montelukast treatment would reduce the rate of clinical deterioration as measured by the COVID-19 Ordinal Scale. Methods We performed a retrospective analysis of COVID-19 confirmed hospitalized patients treated with or without montelukast. We used “clinical deterioration” as the primary endpoint, a binary outcome defined as any increase in the Ordinal Scale value from Day 1 to Day 3 of the hospital stay, as these data were uniformly available for all admitted patients before hospital discharge. Rates of clinical deterioration between the montelukast and non-montelukast groups were compared using the Fisher’s exact test. Univariate logistic regression was also used to assess the association between montelukast use and clinical deterioration. A total of 92 patients were analyzed, 30 who received montelukast at the discretion of the treating physician and 62 patients who did not receive montelukast. Results Patients receiving montelukast experienced significantly fewer events of clinical deterioration compared with patients not receiving montelukast (10% vs 32%, p = 0.022). Our findings suggest that montelukast associates with a reduction in clinical deterioration for COVID-19 confirmed patients as measured on the COVID-19 Ordinal Scale. Conclusions Hospitalized COVID-19 patients treated with montelukast had fewer events of clinical deterioration, indicating that this treatment may have clinical activity. While this retrospective study highlights a potential pathway for COVID-19 treatment, this hypothesis requires further study by prospective studies.

Highlights

Several therapeutic agents have been assessed for the treatment of COVID-19, but few approaches have been proven efficacious
Patients receiving montelukast experienced significantly fewer events of clinical deterioration compared to patients not receiving montelukast (10% vs 32%, p = 0.022)
Our findings suggest that montelukast associates with a reduction in clinical deterioration for COVID-19 confirmed patients as measured on the COVID-19 Ordinal Scale

Summary

Introduction

Several therapeutic agents have been assessed for the treatment of COVID-19, but few approaches have been proven efficacious. Because leukotriene receptor antagonists such as montelukast have been shown to reduce both cytokine release and lung inflammation in preclinical models of viral influenza and acute respiratory distress syndrome, we hypothesized that therapy with montelukast would reduce clinical deterioration as measured by the COVID-19 Ordinal Scale. Coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has been the focal point of the global community since its outbreak in December 2019 due to its tremendous impact on international health, mortality, and the economy. Following the release of conflicting reports of the efficacy of hydroxychloroquine and the expedited clinical trial evaluation of remdesivir, the biomedical community has struggled to find sufficient, effective therapeutic regimens to manage patients with COVID-19 infection[1]. SARS-CoV-2 directly infects alveolar cells, further limiting gas exchange within the lung[5]

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