Effect of Montelukast Therapy on Clinical Course, Pulmonary Function, and Mortality in Patients With COVID-19
Primary Purpose
COVID-19 Pneumonia
Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Standart treatment group
Montelukast sodium 10 mg treatment
Montelukast sodium 20 mg treatment
Sponsored by

About this trial
This is an interventional treatment trial for COVID-19 Pneumonia
Eligibility Criteria
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.
Sites / Locations
- Ataturk University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Standart treatment group
Montelukast sodium 10 mg treatment
Montelukast sodium 20 mg treatment
Arm Description
Standard treatment in accordance with our national COVID-19 diagnosis and treatment guide
Received 10 mg/day oral montelukast in addition to standard treatment
Received 10 mg/day oral montelukast in addition to standard treatment
Outcomes
Primary Outcome Measures
Pulmonary function test
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05094596
Brief Title
Effect of Montelukast Therapy on Clinical Course, Pulmonary Function, and Mortality in Patients With COVID-19
Official Title
ATATURK UNİVERSITY
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 22, 2021 (Anticipated)
Primary Completion Date
December 22, 2021 (Anticipated)
Study Completion Date
January 22, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bugra Kerget
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
'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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standart treatment group
Arm Type
Experimental
Arm Description
Standard treatment in accordance with our national COVID-19 diagnosis and treatment guide
Arm Title
Montelukast sodium 10 mg treatment
Arm Type
Experimental
Arm Description
Received 10 mg/day oral montelukast in addition to standard treatment
Arm Title
Montelukast sodium 20 mg treatment
Arm Type
Experimental
Arm Description
Received 10 mg/day oral montelukast in addition to standard treatment
Intervention Type
Drug
Intervention Name(s)
Standart treatment group
Intervention Description
Group 1 (n=60) received standard treatment in accordance with our national COVID-19 diagnosis and treatment guide.
Intervention Type
Drug
Intervention Name(s)
Montelukast sodium 10 mg treatment
Intervention Description
Group 2 (n=60) received 10 mg/day oral montelukast in addition to standard treatment
Intervention Type
Drug
Intervention Name(s)
Montelukast sodium 20 mg treatment
Intervention Description
Group 3 (n=60) were given 20 mg/day oral montelukast in addition to standard treatment.
Primary Outcome Measure Information:
Title
Pulmonary function test
Description
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.
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ataturk University
City
Erzurum
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Buğra Kerget, Asc.Prof
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Montelukast Therapy on Clinical Course, Pulmonary Function, and Mortality in Patients With COVID-19
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