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NCT Number: NCT04714515

Montelukast - a Treatment Choice for COVID-19

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sars-CoV-2 Infection Virus Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Critical Care Medicine, Shanghai General Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China, Shanghai, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Montelukast

Drug

An FDA approved medicine to treat asthmatic patients

Hydroxychloroquine

Drug

An FDA approved antiarthritis drug

Ivermectin

Drug

An FDA approved anti-parasitic medicine

Primary outcomes

  1. Patients admittance to ICU

    Time frame: 2 Week

    Changes in the number of ICU visits of COVID-19 patients

  2. Length of total stay at the hospital

    Time frame: 2 weeks

    Changes in the length of total stay of patients at the hospital

  3. Alleviating the symptoms of COVID-19

    Time frame: 2 weeks

    Monitoring the changes in disease severity with alleviation of the symptoms

Secondary outcomes

  1. Interleukin levels

    Time frame: 1 Week

    Monitoring the Interleukin levels with the progression of treatments

Sponsors and collaborators

Lead sponsor

University of Sargodha

Other

Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • Shanghai Jiao Tong University School of Medicine
  • Shaukat Khanum Memorial Cancer Hospital & Research Centre
  • Teesside University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 19, 2021
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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