Montelukast - a Treatment Choice for COVID-19
- Conditions
- Covid19SARS-CoV-2 Infection
- Interventions
- Registration Number
- NCT04714515
- Lead Sponsor
- University of Sargodha
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Patients with diagnosed COVID-19
- Patients who are not directly admitted to ICU
- Patients, who were already on immunosuppressants
- Patients with age > 80
- Patient with any known allergies to montelukast
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Hydroxychloroquine, Montelukast and Invermectin Hydroxychloroquine Group 4 was given Standard of care (SOC) + Montelukast + HCQ and Ivermectin Hydroxychloroquine, Montelukast and Invermectin Ivermectin Group 4 was given Standard of care (SOC) + Montelukast + HCQ and Ivermectin Hydroxychloroquine and Montelukast Montelukast Group 1 was given Standard of care (SOC) + HCQ + Montelukast Hydroxychloroquine and Montelukast Hydroxychloroquine Group 1 was given Standard of care (SOC) + HCQ + Montelukast Montelukast Montelukast Group 2 was given Standard of care (SOC) + Montelukast Hydroxychloroquine, Montelukast and Invermectin Montelukast Group 4 was given Standard of care (SOC) + Montelukast + HCQ and Ivermectin Hydroxychloroquine Hydroxychloroquine Group 3 was given Standard of care (SOC) + HCQ
- Primary Outcome Measures
Name Time Method 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
Patients admittance to ICU 2 Week Changes in the number of ICU visits of COVID-19 patients
- Secondary Outcome Measures
Name Time Method Interleukin levels 1 Week Monitoring the Interleukin levels with the progression of treatments
Trial Locations
- Locations (2)
Department of Critical Care Medicine, Shanghai General Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China
🇨🇳Shanghai, China
Shaukat Khanum Memorial Cancer Hospital & Research Centre, Johar Town, Lahore, Pakistan
🇵🇰Lahore, Punjab, Pakistan