Effect of Montelukast Therapy on Clinical Course, Pulmonary Function, and Mortality in Patients With COVID-19

October 22, 2021 updated by: Bugra Kerget

ATATURK UNİVERSITY

'Pandemic' is a medical term that has become a ubiquitous part of the global vocabulary over the last year. Although pandemics have occurred throughout human history, their sociocultural, economic, and psychological impact can leave lasting damage. In the current COVID-19 pandemic, more than 200 million confirmed cases of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection have been reported to date. While most people present with mild symptoms such as loss of taste and smell, sore throat, joint pain, and headache, it can cause serious morbidity and mortality, especially in individuals over 65 years of age and those with comorbidities .

Acute respiratory distress syndrome (ARDS) and macrophage activation syndrome (MAS) are among the main causes of morbidity and mortality in COVID-19. A contributing factor in the development of these clinical conditions is overproduction of proinflammatory cytokines, primarily tumor necrosis factor alpha (TNF-α), interleukin-6 (IL-6), IL-8, and IL-1β. These cytokines cause increased leukocyte accumulation in the alveolar spaces and consequently an increase in reactive oxygen radicals and proteases, which inevitably leads to capillary endothelial damage and alveolar epithelial damage .

Montelukast is a potent cysteinyl leukotriene (cysLT) receptor antagonist with anti-inflammatory activity and has been proven to significantly suppress oxidative stress. Moreover, cysLTs also have an important role in the regulation of cytokine production. Administration of high doses of montelukast reduces IL-4, IL-5, and IL-13 production by T helper 2 cells . This effect makes it an important anti-inflammatory agent in the treatment of asthma. In addition, montelukast was shown to significantly inhibit bradykinin-induced tracheal smooth muscle contraction, thus supporting an interaction between bradykinin and leukotriene mediators .

In studies investigating the efficacy of cysLT for ARDS and MAS, montelukast was found to increase interferon gamma (IFN-γ) production and significant decrease the production of proinflammatory cytokines such as IL-1β, IL-6, and IL-8 in mice infected with respiratory syncytial virus. In another study, cysLT prevented neutrophil infiltration, lung inflammation, and oxidative stress and significantly decreased levels of TNF-α and IL-6 in both the lung parenchyma and bronchoalveolar lavage fluid in an animal model of ARDS induced by hemorrhagic shock.

In this study, the investigators aimed to investigate the effect of treatment with varying doses of montelukast as an adjunct to standard antiviral therapy on pulmonary function tests and clinical course in patients with COVID-19.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzurum, Turkey
        • Ataturk University
        • Contact:
          • Buğra Kerget, Asc.Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The prospective controlled randomized study included patients who presented to the emergency department of Erzurum Regional Training and Research Hospital with history of travel abroad within the last 14 days or contact with a confirmed or suspected COVID-19 patient and had recent complaints of fever, cough, dyspnea, malaise, and sudden loss of taste and smell. Patients regarded as high risk for COVID-19 underwent standard high-resolution computed tomography (HRCT). Predominantly peripheral bilateral ground glass opacities, subsegmental consolidation or linear opacities, crazy-paving pattern, and reverse halo sign were considered typical HRCT findings for COVID-19. Patients with these findings and patients with radiologically atypical findings but consistent clinical symptoms were hospitalized with suspected COVID-19. The diagnosis was confirmed by SARS-CoV-2 real-time polymerase chain reaction (PCR) testing of nasopharyngeal swab samples.

Exclusion Criteria:

  • Patients with any potential contraindications to pulmonary function testing (recent myocardial infarction, pulmonary embolism, cerebral aneurysm, active hemoptysis, pneumothorax, nausea/vomiting, recent thoracic, abdominal, or ocular surgery) were excluded before testing. In addition, patients who developed ARDS or MAS associated with secondary bacterial infection during the first week of treatment were also excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Standart treatment group
Standard treatment in accordance with our national COVID-19 diagnosis and treatment guide
Drug: Standart treatment group
Group 1 (n=60) received standard treatment in accordance with our national COVID-19 diagnosis and treatment guide.
EXPERIMENTAL: Montelukast sodium 10 mg treatment
Received 10 mg/day oral montelukast in addition to standard treatment
Drug: Standart treatment group
Group 1 (n=60) received standard treatment in accordance with our national COVID-19 diagnosis and treatment guide.
Drug: Montelukast sodium 10 mg treatment
Group 2 (n=60) received 10 mg/day oral montelukast in addition to standard treatment
EXPERIMENTAL: Montelukast sodium 20 mg treatment
Received 10 mg/day oral montelukast in addition to standard treatment
Drug: Standart treatment group
Group 1 (n=60) received standard treatment in accordance with our national COVID-19 diagnosis and treatment guide.
Drug: Montelukast sodium 20 mg treatment
Group 3 (n=60) were given 20 mg/day oral montelukast in addition to standard treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary function test
Time Frame: 3 month
Pulmonary function tests were performed in a negative-pressure room by a technician wearing protective equipment to prevent transmission. Before testing, patients were instructed to abstain from smoking (24 hours), alcohol (4 hours), strenuous exercise (30 minutes), and heavy meals (2 hours). The patients' age, height, and weight were recorded. Tests were performed with the patients lightly dressed and BTPS correction was performed according to room air and barometric pressure. The technician explained the maneuver to the patients and three acceptable spirograms were obtained.
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bugra Kerget

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 22, 2021

Primary Completion (ANTICIPATED)

December 22, 2021

Study Completion (ANTICIPATED)

January 22, 2022

Study Registration Dates

First Submitted

October 21, 2021

First Submitted That Met QC Criteria

October 22, 2021

First Posted (ACTUAL)

October 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 22, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATATURK-BUGRA-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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