Montelukast - a Treatment Choice for COVID-19

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04714515
• Other study ID #: 01032020-7
• Status: Completed
• Start date: February 20, 2020
• Est. completion date: April 20, 2020

Study information

• Verified date: January 2021
• Source: University of Sargodha
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 20, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• SARS-CoV-2 Infection

Intervention

Drug:
• Montelukast
An FDA approved medicine to treat asthmatic patients
• Hydroxychloroquine
An FDA approved antiarthritis drug
• Ivermectin
An FDA approved anti-parasitic medicine

Locations

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

Sponsors (5)

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

Countries where clinical trial is conducted

China,  Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients admittance to ICU	Changes in the number of ICU visits of COVID-19 patients	2 Week
Primary	Length of total stay at the hospital	Changes in the length of total stay of patients at the hospital	2 weeks
Primary	Alleviating the symptoms of COVID-19	Monitoring the changes in disease severity with alleviation of the symptoms	2 weeks
Secondary	Interleukin levels	Monitoring the Interleukin levels with the progression of treatments	1 Week