Montelukast - a Treatment Choice for COVID-19

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19, SARS-CoV-2 Infection

Intervention / Treatment
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* Drug: Montelukast
* Drug: Hydroxychloroquine
* Drug: Ivermectin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Montelukast