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Montelukast - a Treatment Choice for COVID-19

Using Montelukast to Treat the Patients Infected With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04714515
Enrollment
150
Registered
2021-01-19
Start date
2020-02-20
Completion date
2020-04-20
Last updated
2021-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, SARS-CoV-2 Infection

Keywords

COVID-19, Montelukast

Brief summary

The current study aimed to make a therapeutic comparison and effectiveness of Hydroxychloroquine (HCQ) and Montelukast (ML) in COVID-19 patients in addition to the standard of care. The safety and efficacy of HCQ and ML will be assessed as individual therapy and in combination with each other and with the standard of care. Cytokine storm (Interleukin levels) also will be monitored throughout the study to assess treatment progression.

Detailed description

To date, no specific medication is available for COVID-19. Many FDA-approved drugs, including antivirals, antibacterials, and anti-inflammatory compositions are being tested with the intention of repurposing against COVID-19. In this study, investigators have evaluated the effectiveness of Hydroxychloroquine (HCQ) and Montelukast (ML) in an individual and combination therapy. Investigators have performed an observational study of 100 hospitalized COVID-19 patients while assessing the safety and efficacy of HCQ, ML, and IV as individual therapy and in combination with each other. ECG, interleukin levels, LFTs, blood profiles were continuously monitored throughout the study. The aim was to observe participants treated with ML and monitor the inflammatory markers to see whether they increase or decrease and whether an increase in survival rate is observed. The findings have shown that combinational therapy of ML with continuous observation of liver/kidney profiles and QTc prolongation can provide robust recovery with suppression of cytokines.

Interventions

DRUGMontelukast

An FDA approved medicine to treat asthmatic patients

DRUGHydroxychloroquine

An FDA approved antiarthritis drug

DRUGIvermectin

An FDA approved anti-parasitic medicine

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
Shaukat Khanum Memorial Cancer Hospital & Research Centre
CollaboratorOTHER
Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
Teesside University
CollaboratorOTHER
University of Sargodha
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients with diagnosed COVID-19 * Patients who are not directly admitted to ICU

Exclusion criteria

* Patients, who were already on immunosuppressants * Patients with age \> 80 * Patient with any known allergies to montelukast

Design outcomes

Primary

MeasureTime frameDescription
Patients admittance to ICU2 WeekChanges in the number of ICU visits of COVID-19 patients
Length of total stay at the hospital2 weeksChanges in the length of total stay of patients at the hospital
Alleviating the symptoms of COVID-192 weeksMonitoring the changes in disease severity with alleviation of the symptoms

Secondary

MeasureTime frameDescription
Interleukin levels1 WeekMonitoring the Interleukin levels with the progression of treatments

Countries

China, Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026