NCT04714515

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
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: University of Sargodha · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19
• SARS-CoV-2 Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-02-20
• Primary completion: 2020-03-30
• Completion: 2020-04-20
• First posted: 2021-01-19
• Last updated: 2021-01-19

Locations

2 sites across 2 countries: China, Pakistan

Regulatory

• FDA-regulated drug study