Montelukast - a Treatment Choice for COVID-19

January 15, 2021 updated by: Muhammad Fayyaz ur Rehman, University of Sargodha

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Department of Critical Care Medicine, Shanghai General Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China
  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54600
        • Shaukat Khanum Memorial Cancer Hospital & Research Centre, Johar Town, Lahore, Pakistan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients, who were admitted to the hospitals with SARS-CoV-2 contacts (environmental exposure or close contact) or obvious COVID-19 symptoms and were diagnosed with COVID-19 using the PCR tests. Consent was obtained from all patients with a detailed history of any known co-morbidities.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hydroxychloroquine and Montelukast
Group 1 was given Standard of care (SOC) + HCQ + Montelukast
Drug: Montelukast
An FDA approved medicine to treat asthmatic patients
Drug: Hydroxychloroquine
An FDA approved antiarthritis drug
Montelukast
Group 2 was given Standard of care (SOC) + Montelukast
Drug: Montelukast
An FDA approved medicine to treat asthmatic patients
Hydroxychloroquine
Group 3 was given Standard of care (SOC) + HCQ
Drug: Hydroxychloroquine
An FDA approved antiarthritis drug
Hydroxychloroquine, Montelukast and Invermectin
Group 4 was given Standard of care (SOC) + Montelukast + HCQ and Ivermectin
Drug: Montelukast
An FDA approved medicine to treat asthmatic patients
Drug: Hydroxychloroquine
An FDA approved antiarthritis drug
Drug: Ivermectin
An FDA approved anti-parasitic medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients admittance to ICU
Time Frame: 2 Week
Changes in the number of ICU visits of COVID-19 patients
2 Week
Length of total stay at the hospital
Time Frame: 2 weeks
Changes in the length of total stay of patients at the hospital
2 weeks
Alleviating the symptoms of COVID-19
Time Frame: 2 weeks
Monitoring the changes in disease severity with alleviation of the symptoms
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interleukin levels
Time Frame: 1 Week
Monitoring the Interleukin levels with the progression of treatments
1 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sargodha

Collaborators

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

Investigators

  • Principal Investigator: Wei Zhang, MD, Department of Critical Care Medicine, Shanghai General Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China
  • Principal Investigator: Muhammad Rehman Akram, MBBS, Shaukat Khanum Memorial Cancer Hospital & Research Centre, Johar Town, Lahore, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2020

Primary Completion (Actual)

March 30, 2020

Study Completion (Actual)

April 20, 2020

Study Registration Dates

First Submitted

September 19, 2020

First Submitted That Met QC Criteria

January 15, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01032020-7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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