NCT04718285

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
380

participants targeted

Target at P75+ for phase_2 covid19

Timeline
Completed

Started May 2021

Typical duration for phase_2 covid19

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

May 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

12 months

First QC Date

January 15, 2021

Last Update Submit

April 21, 2022

Conditions

COVID-19SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

  • Hospitalized patient rates

    The number of hospitalized patients

    15 days

Secondary Outcomes (14)

  • Emergency room visit rates of patients

    15 days

  • Time to emergency room visit

    15 days

  • Time to hospitalization

    15 days

  • Inpatient length of stay

    15 days

  • Time to ICU admission

    15 days

  • +9 more secondary outcomes

Study Arms (3)

Montelukast

EXPERIMENTAL

3x10 mg oral montelukast first day (morning, noon time and evening) and rest of the 13 days 1 x 10 mg montelukast.

Drug: Montelukast Oral Tablet

Montelukast plus Favicovir (Favipiravir)

EXPERIMENTAL

200 mg oral favicovir for 5 days in a regimen of 2x1600 mg (oral) loading dose on day-1 (eight tablets in the morning and eight tablets in the evening) followed by 2x600 mg maintenance dose (three tablets in the morning and three tablets in the evening) on day-2 to day-5 and 3x10 mg oral montelukast at the first day and rest of the 13 days1 x 10 mg, concurrently.

Drug: Montelukast plus Favicovir (Favipiravir)

Favicovir (Standard Treatment)

ACTIVE COMPARATOR

200 mg oral favicovir for 5 days in a regimen of 2x1600 mg (oral) loading dose on day-1 (eight tablets in the morning and eight tablets in the evening) followed by 2x600 mg maintenance dose (three tablets in the morning and three tablets in the evening) on day-2 to day-5.

Drug: Favicovir (Standard Treatment)

Interventions

Montelukast Oral TabletDRUG

3x10 mg oral montelukast first day and other 13 days 1 x 10 mg montelukast

Montelukast
Montelukast plus Favicovir (Favipiravir)DRUG

200 mg oral favicovir for 5 days in a regimen of 2x1600 mg (oral) loading dose on day-1 (eight tablets in the morning and eight tablets in the evening) followed by 2x600 mg maintenance dose (three tablets in the morning and three tablets in the evening) on day-2 to day-5 and 3x10 mg oral montelukast first day and rest of 13 days 1 x 10mg, concurrently.

Montelukast plus Favicovir (Favipiravir)
Favicovir (Standard Treatment)DRUG

200 mg oral favicovir for 5 days in a regimen of 2x1600 mg (oral) loading dose on day-1 (eight tablets in the morning and eight tablets in the evening) followed by 2x600 mg maintenance dose (three tablets in the morning and three tablets in the evening) on day-2 to day-5.

Favicovir (Standard Treatment)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bahcesehir University, School of Medicine, Department of Biophysics,

Istanbul, Turkey (Türkiye)

RECRUITING

Istanbul University, Cerrahpaşa School of Medicine

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Durdagi S, Avsar T, Orhan MD, Serhatli M, Balcioglu BK, Ozturk HU, Kayabolen A, Cetin Y, Aydinlik S, Bagci-Onder T, Tekin S, Demirci H, Guzel M, Akdemir A, Calis S, Oktay L, Tolu I, Butun YE, Erdemoglu E, Olkan A, Tokay N, Isik S, Ozcan A, Acar E, Buyukkilic S, Yumak Y. The neutralization effect of montelukast on SARS-CoV-2 is shown by multiscale in silico simulations and combined in vitro studies. Mol Ther. 2022 Feb 2;30(2):963-974. doi: 10.1016/j.ymthe.2021.10.014. Epub 2021 Oct 19.

    PMID: 34678509BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

montelukastfavipiravir

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Prof. Serdar Durdagi, Ph.D.

CONTACT

+90-216-579-8217serdar.durdagi@med.bau.edu.tr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof., Ph.D.

Study Record Dates

First Submitted

January 15, 2021

First Posted

January 22, 2021

Study Start

May 15, 2021

Primary Completion

May 1, 2022

Study Completion

June 1, 2022

Last Updated

April 28, 2022

Record last verified: 2022-04

Locations

TU(2)