Overview

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