Investigation the Effect of Montelukast in COVID-19

• Status: Not yet recruiting
• Trial end date: 2021-05-30
• Target enrollment: 0
• Participant gender: All

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 identified the leukotriene (D4) receptor antagonist Montelukast as a novel agent that simultaneously targets two important drug targets of SARS-CoV-2. The investigators initially demonstrated the dual inhibition (main protease and Spike/ACE2) profile of Montelukast through multiscale molecular modeling studies. Next, the investigators characterized its effect on both targets by different in vitro experiments including the Fluorescent Resonance Energy Transfer (FRET)-based main protease enzyme inhibition assay, surface plasmon resonance (SPR) spectroscopy, pseudovirus neutralization on HEK293T / hACE2, and virus neutralization assay using xCELLigence MP real time cell analyzer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bahçeşehir University
• Collaborators: Medipol University; The Scientific and Technological Research Council of Turkey
• Treatments: Favipiravir; Montelukast

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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