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

Authors

  • Vijay Kumar Department of General Medicine, All India Institute of Medical Sciences, Patna, Bihar, India http://orcid.org/0000-0001-6042-7784
  • Avinash A. Ganapule Department of General Medicine, All India Institute of Medical Sciences, Patna, Bihar, India
  • Sushmita Supriya Department of General Medicine, All India Institute of Medical Sciences, Patna, Bihar, India
  • Divendu Bhushan Department of General Medicine, All India Institute of Medical Sciences, Patna, Bihar, India
  • Pallavi Lohani Department of CFM, All India Institute of Medical Sciences, Patna, Bihar, India
  • Sanjay Pandey Department of CFM, All India Institute of Medical Sciences, Patna, Bihar, India
  • B. Hilbert Sahoo Department of General Medicine, All India Institute of Medical Sciences, Patna, Bihar, India
  • Anjani Kumar Department of General Medicine, All India Institute of Medical Sciences, Patna, Bihar, India
  • Shruti Singh Department of Pharmacology, All India Institute of Medical Sciences, Patna, Bihar, India
  • Ramesh Kumar Department of Gastroenterology, All India Institute of Medical Sciences, Patna, Bihar, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20214502

Keywords:

COVID-19, Montelukast, Randomized controlled trial

Abstract

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.

Author Biography

Vijay Kumar, Department of General Medicine, All India Institute of Medical Sciences, Patna, Bihar, India

ASSOCIATE PROFESSOR,DEPARTMENT OF GENERAL MEDICINE,ALL INDIA INSTITUTE OF MEDICAL SCIENCES(AIIMS),PATNA, BIHAR, INDIA

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Published

2021-11-22

How to Cite

Kumar, V., Ganapule, A. A., Supriya, S., Bhushan, D., Lohani, P., Pandey, S., Sahoo, B. H., Kumar, A., Singh, S., & Kumar, R. (2021). Efficacy of montelukast in the management of COVID-19: double blind randomized placebo controlled trial. International Journal of Basic & Clinical Pharmacology, 10(12), 1374–1379. https://doi.org/10.18203/2319-2003.ijbcp20214502

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Section

Original Research Articles