Status:
UNKNOWN
Investigation the Effect of Montelukast in COVID-19
Lead Sponsor:
Bahçeşehir University
Collaborating Sponsors:
Medipol University
The Scientific and Technological Research Council of Turkey
Conditions:
COVID-19
SARS-CoV-2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Small molecule inhibitors have previously been investigated in different studies as possible therapeutics in the treatment of SARS-CoV-2. In the current drug repurposing study, the investigators ident...
Detailed Description
The 2019 new coronavirus (SARS-CoV-2), was first reported in December 2019 in Wuhan (Hubei, China). It has quickly spread to other countries all around the world and effected more than 67 million peop...
Eligibility Criteria
Inclusion
- Male or female patients aged 18 years and older infected with the SARS-CoV-2 infection
- Patients with COVID-19 symptoms and have a positive PCR test result
- Patients in a stable clinical condition and basically in an outpatient condition
- Patients who sign the informed consent
Exclusion
- Patients with a partial oxygen pressure \< 90% and who have required hospitalization
- Patients who have required intensive care
- Any condition which, in the opinion of the Principal Investigator, would prevent full participation in and compliance with the trial protocol
- Patients who have been involved in any other interventional studies
- Patients with uncontrolled Type I or Type II diabetes mellitus (DM)
- Patients with severe liver failure (Child Pugh score ≥ C, AST\> 5 times the upper limit of normal (ULN)
- Patients with severe renal failure (GFR ≤30 mL/min/1.73 m2) or continuous dialysis (hemodialysis, peritoneal dialysis) or continuous renal replacement therapy
- Patients with serious cardiac problems such as heart failure
- Patients with hypersensitivity to montelukast or other drugs in the study
- Patients with rare hereditary problems of galactose / fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency
- Pregnant and lactating women
- Patients who cannot use sexual abstinence or appropriate contraceptive method during the study
- Patients who are treated with any other antiviral drugs for COVID-19 in the last 30 days
Key Trial Info
Start Date :
May 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT04718285
Start Date
May 15 2021
End Date
June 1 2022
Last Update
April 28 2022
Active Locations (2)
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1
Bahcesehir University, School of Medicine, Department of Biophysics,
Istanbul, Turkey (Türkiye)
2
Istanbul University, Cerrahpaşa School of Medicine
Istanbul, Turkey (Türkiye)