Montelukast - a Treatment Choice for COVID-19

University of Sargodha

Status: Completed

Conditions: SARS-CoV-2 Infection; Covid19

Treatments: Drug: Ivermectin; Drug: Hydroxychloroquine; Drug: Montelukast

Study type: Observational

Funder types: Other

Identifiers

NCT04714515

01032020-7

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

150 participants in 4 patient groups

Hydroxychloroquine and Montelukast

Description:

Group 1 was given Standard of care (SOC) + HCQ + Montelukast

Treatment:

Drug: Hydroxychloroquine

Drug: Montelukast

Montelukast

Description:

Group 2 was given Standard of care (SOC) + Montelukast

Treatment:

Drug: Montelukast

Hydroxychloroquine

Description:

Group 3 was given Standard of care (SOC) + HCQ

Treatment:

Drug: Hydroxychloroquine

Hydroxychloroquine, Montelukast and Invermectin

Description:

Group 4 was given Standard of care (SOC) + Montelukast + HCQ and Ivermectin

Treatment:

Drug: Hydroxychloroquine

Drug: Montelukast

Drug: Ivermectin