---
title: Montelukast - a Treatment Choice for COVID-19
nct_id: NCT04714515
overall_status: COMPLETED
sponsor: University of Sargodha
study_type: OBSERVATIONAL
primary_condition: Covid19
countries: China, Pakistan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04714515.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04714515"
ct_last_update_post_date: 2021-01-19
last_seen_at: "2026-05-12T06:47:24.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Montelukast - a Treatment Choice for COVID-19

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

**NCT ID:** [NCT04714515](https://clinicaltrials.gov/study/NCT04714515)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 150
- **Lead Sponsor:** University of Sargodha
- **Collaborators:** Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shaukat Khanum Memorial Cancer Hospital & Research Centre, Shanghai Jiao Tong University School of Medicine, Teesside University
- **Conditions:** Covid19, SARS-CoV-2 Infection
- **Start Date:** 2020-02-20
- **Completion Date:** 2020-04-20
- **CT.gov Last Update:** 2021-01-19

## 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.

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **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
```

## Arms

- **Hydroxychloroquine and Montelukast** — Group 1 was given Standard of care (SOC) + HCQ + Montelukast
- **Montelukast** — Group 2 was given Standard of care (SOC) + Montelukast
- **Hydroxychloroquine** — Group 3 was given Standard of care (SOC) + HCQ
- **Hydroxychloroquine, Montelukast and Invermectin** — Group 4 was given Standard of care (SOC) + Montelukast + HCQ and Ivermectin

## Interventions

- **Montelukast** (DRUG) — An FDA approved medicine to treat asthmatic patients
- **Hydroxychloroquine** (DRUG) — An FDA approved antiarthritis drug
- **Ivermectin** (DRUG) — An FDA approved anti-parasitic medicine

## Primary Outcomes

- **Patients admittance to ICU** _(time frame: 2 Week)_ — Changes in the number of ICU visits of COVID-19 patients
- **Length of total stay at the hospital** _(time frame: 2 weeks)_ — Changes in the length of total stay of patients at the hospital
- **Alleviating the symptoms of COVID-19** _(time frame: 2 weeks)_ — Monitoring the changes in disease severity with alleviation of the symptoms

## Secondary Outcomes

- **Interleukin levels** _(time frame: 1 Week)_

## Locations (2)

- Department of Critical Care Medicine, Shanghai General Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China, Shanghai, China
- Shaukat Khanum Memorial Cancer Hospital & Research Centre, Johar Town, Lahore, Pakistan, Lahore, Punjab Province, Pakistan

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of critical care medicine, shanghai general hospital, shanghai jiao tong university, school of medicine, shanghai, china|shanghai||china` — added _(2026-05-12)_
- `locations.shaukat khanum memorial cancer hospital & research centre, johar town, lahore, pakistan|lahore|punjab province|pakistan` — added _(2026-05-12)_

---

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