Montelukast - a Treatment Choice for COVID-19

Sponsor

University of Sargodha (Other)

Overall Status

Completed

CT.gov ID

NCT04714515

Collaborator

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

150

Enrollment

Locations

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 SARS-CoV-2 Infection	Drug: Montelukast Drug: Hydroxychloroquine Drug: Ivermectin

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 Design

Study Type:

Observational

Actual Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Feb 20, 2020

Actual Primary Completion Date :

Mar 30, 2020

Actual Study Completion Date :

Apr 20, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

Patients admittance to ICU [2 Week]
Changes in the number of ICU visits of COVID-19 patients
Length of total stay at the hospital [2 weeks]
Changes in the length of total stay of patients at the hospital
Alleviating the symptoms of COVID-19 [2 weeks]
Monitoring the changes in disease severity with alleviation of the symptoms

Secondary Outcome Measures

Interleukin levels [1 Week]
Monitoring the Interleukin levels with the progression of treatments

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Critical Care Medicine, Shanghai General Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China	Shanghai		China
2	Shaukat Khanum Memorial Cancer Hospital & Research Centre, Johar Town, Lahore, Pakistan	Lahore	Punjab	Pakistan	54600

Sponsors and Collaborators

University of Sargodha
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

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