Published: 2021-11-22

Efficacy of montelukast in the management of COVID-19: double blind randomized placebo controlled trial

Vijay Kumar, Avinash A. Ganapule, Sushmita Supriya, Divendu Bhushan, Pallavi Lohani, Sanjay Pandey, B. Hilbert Sahoo, Anjani Kumar, Shruti Singh, Ramesh Kumar


Background: Objective of the study was to determine the efficacy of montelukast in reducing the severity of COVID-19 symptoms using a double blinded randomized controlled trial.

Methods: Parallel, double-blinded randomized controlled trial (RCT) with placebo as comparison to montelukast. All patients above the age of 14 years both males and females, admitted with a diagnosis of mild or moderate COVID-19 (on the basis of a positive reverse transcriptase polymerase chain reaction (RT-PCR) report) at our facility during the study period from 01 September 2020-31 January 2021) and excluding those having adverse reaction to montelukast or those not willing to participate, and pregnant and lactating females. Patients in the intervention arm were given tablet montelukast 10 mg OD HS from the day of admission for 10 days. The patients in the placebo group were given an identical appearing placebo at bedtime for 10 days from the day of admission. The rest of the treatment was given as per the standard operating procedure (SOP) of the institute with minor adjustments as per the treating team’s judgement. Primary outcome was progression of the disease to severe grade and secondary outcomes were discharge on or before day 10 from admission, admission to ICU, need for mechanical ventilation and in-hospital mortality.

Results: A total of 94 patients were enrolled for the study. 90 patients, 45 in each arm were included in the final analysis. The baseline characteristics of the two arms including age, sex, comorbidities, severity at admission and treatment given apart from montelukast or placebo, were comparable with respect to these variables. This study did not find any improvement in primary outcome of progression to severe disease and secondary outcomes of intensive care unit (ICU) admission, mortality or need of mechanical ventilation, discharge on or by day 10 with the use of montelukast as compared to placebo in mild to moderate cases of COVID-19.

Conclusions: There was no difference in primary or secondary outcomes with the use of Montelukast compared to placebo.


COVID-19, Montelukast, Randomized controlled trial

Full Text:



Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, et al. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020;382(8):727-33.

Dexamethasone in Hospitalized Patients with Covid-19. N Engl J Med. 2021;384(8):693-704.

Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, et al. Remdesivir for the Treatment of Covid-19 — Final Report. N Engl J Med. 2020;383(19):1813-26.

Repurposed Antiviral Drugs for Covid-19 — Interim WHO Solidarity Trial Results. N Engl J Med. 2021;384(6):497-511.

Salama C, Han J, Yau L, Reiss WG, Kramer B, Neidhart JD, et al. Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia. N Engl J Med. 2021;384(1):20-30.

Group RC, Horby PW, Pessoa-Amorim G, Peto L, Brightling CE, Sarkar R, et al. Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): preliminary results of a randomised, controlled, open-label, platform trial. medRxiv. 2021.

Cadegiani FA. Repurposing existing drugs for COVID-19: an endocrinology perspective. BMC Endocr Disord. 2020;20(1):1-19.

López-Medina E, López P, Hurtado IC, Dávalos DM, Ramirez O, Martínez E, et al. Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19: A Randomized Clinical Trial. JAMA. 2021;325(14):1426.

Echeverría-Esnal D, Martin-Ontiyuelo C, Navarrete-Rouco ME, De-Antonio Cuscó M, Ferrández O, Horcajada JP, Grau S. Azithromycin in the treatment of COVID-19: a review. Expert Rev Anti Infect Ther. 2021;19(2):147-63.

Fidan C, Aydoğdu A. As a potential treatment of COVID-19: Montelukast. Med Hypotheses. 2020;142:109828.

Lima-Morales R, Méndez-Hernández P, Flores YN, Osorno-Romero P, Sancho-Hernández CR, Cuecuecha-Rugerio E, et al. Effectiveness of a multidrug therapy consisting of Ivermectin, Azithromycin, Montelukast, and Acetylsalicylic acid to prevent hospitalization and death among ambulatory COVID-19 cases in Tlaxcala, Mexico. Int J Infect Dis. 2021;105:598-605.

Keeley P, Buchanan D, Carolan C, Pivodic L, Tavabie S, Noble S. Symptom burden and clinical profile of COVID-19 deaths: a rapid systematic review and evidence summary. BMJ Support Palliat Care. 2020;10(4):381-4.

Nile SH, Nile A, Qiu J, Li L, Jia X, Kai G. COVID-19: Pathogenesis, cytokine storm and therapeutic potential of interferons. Cytokine Growth Factor Rev. 2020;53:66-70.

Chen X, Zhang X, Pan J. Effect of Montelukast on Bronchopulmonary Dysplasia (BPD) and Related Mechanisms. Med Sci Monit Int Med J Exp Clin Res. 2019;25:1886-93.

Wu AY, Chik SC, Chan AW, Li Z, Tsang KW, Li W. Anti-inflammatory effects of high-dose montelukast in an animal model of acute asthma. Clin Exp Allergy. 2003;33(3):359-66.

Noor A, Najmi MH, Bukhtiar S. Effect of Montelukast on bradykinin-induced contraction of isolated tracheal smooth muscle of guinea pig. Indian J Pharmacol. 2011;43(4):445-9.

Bozek A, Winterstein J. Montelukast’s ability to fight COVID-19 infection. J Asthma. 2020;1-2.

Barré J, Sabatier JM, Annweiler C. Montelukast Drug May Improve COVID-19 Prognosis: A Review of Evidence. Front Pharmacol. 2020;11:1344.

Khan AR, Misdary C, Yegya-Raman N, Kim S, Narayanan N, Siddiqui S, et al. Montelukast in hospitalized patients diagnosed with COVID-19. J Asthma. 2021;0(0):1-7.

Tavares M, Farraia M, Silva S, Ribeiro AM, Severo M, Paciência I, et al. Impact of montelukast as add on treatment to the novel coronavirus pneumonia (COVID-19): protocol for an investigator-initiated open labeled randomized controlled pragmatic trial. Porto Biomed J. 2021;6(2).

Wilchesky M. Repurposing Montelukast for the Attenuation and Prophylaxis of Severe COVID-19 Symptoms: The COvid-19 Symptom MOntelukast (COSMO) Trial. Available at: https://clinical Accessed on 25 April 2021.

Clinical Management Protocol for COVID-19. Available at: ManagementProtocolforCOVID19.pdf. Accessed on 29 April 2021.