Using Montelukast to Treat the Patients Infected With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Length of total stay at the hospital
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosed COVID-19
- •Patients who are not directly admitted to ICU
排除标准
- •Patients, who were already on immunosuppressants
- •Patients with age > 80
- •Patient with any known allergies to montelukast
研究组 & 干预措施
Hydroxychloroquine and Montelukast
Group 1 was given Standard of care (SOC) + HCQ + Montelukast
干预措施: Montelukast (Drug)
Hydroxychloroquine and Montelukast
Group 1 was given Standard of care (SOC) + HCQ + Montelukast
干预措施: Hydroxychloroquine (Drug)
Montelukast
Group 2 was given Standard of care (SOC) + Montelukast
干预措施: Montelukast (Drug)
Hydroxychloroquine
Group 3 was given Standard of care (SOC) + HCQ
干预措施: Hydroxychloroquine (Drug)
Hydroxychloroquine, Montelukast and Invermectin
Group 4 was given Standard of care (SOC) + Montelukast + HCQ and Ivermectin
干预措施: Montelukast (Drug)
Hydroxychloroquine, Montelukast and Invermectin
Group 4 was given Standard of care (SOC) + Montelukast + HCQ and Ivermectin
干预措施: Hydroxychloroquine (Drug)
Hydroxychloroquine, Montelukast and Invermectin
Group 4 was given Standard of care (SOC) + Montelukast + HCQ and Ivermectin
干预措施: Ivermectin (Drug)
结局指标
主要结局
Length of total stay at the hospital
时间窗: 2 weeks
Changes in the length of total stay of patients at the hospital
Alleviating the symptoms of COVID-19
时间窗: 2 weeks
Monitoring the changes in disease severity with alleviation of the symptoms
Patients admittance to ICU
时间窗: 2 Week
Changes in the number of ICU visits of COVID-19 patients
次要结局
- Interleukin levels(1 Week)
研究者
Muhammad Fayyaz ur Rehman
Principal Investigator
University of Sargodha