Investigation the Effect of Montelukast in COVID-19
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ClinicalTrials.gov Identifier: NCT04718285 |
Recruitment Status : Unknown
Verified April 2022 by Serdar Durdagi, Bahçeşehir University.
Recruitment status was: Recruiting
First Posted : January 22, 2021
Last Update Posted : April 28, 2022
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 SARS-CoV-2 | Drug: Montelukast Oral Tablet Drug: Montelukast plus Favicovir (Favipiravir) Drug: Favicovir (Standard Treatment) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 380 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A National, Multi-Center, Open-Label, Three-Arm, Phase II Study to Investigate the Effect of Montelukast Between Emergency Room Visits and Hospitalizations in COVID-19 Pneumonia in Comparison With Standard Treatment |
Actual Study Start Date : | May 15, 2021 |
Estimated Primary Completion Date : | May 1, 2022 |
Estimated Study Completion Date : | June 1, 2022 |
Arm | Intervention/treatment |
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Experimental: Montelukast
3x10 mg oral montelukast first day (morning, noon time and evening) and rest of the 13 days 1 x 10 mg montelukast.
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Drug: Montelukast Oral Tablet
3x10 mg oral montelukast first day and other 13 days 1 x 10 mg montelukast |
Experimental: Montelukast plus Favicovir (Favipiravir)
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.
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Drug: Montelukast plus Favicovir (Favipiravir)
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. |
Active Comparator: Favicovir (Standard Treatment)
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.
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Drug: Favicovir (Standard Treatment)
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. |
- Hospitalized patient rates [ Time Frame: 15 days ]The number of hospitalized patients
- Emergency room visit rates of patients [ Time Frame: 15 days ]The number of emergency room visits of patients not hospitalized
- Time to emergency room visit [ Time Frame: 15 days ]The time (days) until the emergency room visit
- Time to hospitalization [ Time Frame: 15 days ]The time (days) until the hospitalization
- Inpatient length of stay [ Time Frame: 15 days ]Length of stay in the hospital (days)
- Time to ICU admission [ Time Frame: 15 days ]The time (days) until admission to intensive care unit
- Time to intubation [ Time Frame: 15 days ]The time (days) until intubation
- Mortality rate [ Time Frame: 15 days ]All-cause mortality rate
- Family members rates with PCR positive test results [ Time Frame: 15 days ]The number of family members with PCR positive
- Number/characteristics of AEs and SAEs [ Time Frame: 21 days ]Number/characteristics of Adverse Event (AE) and Serious Adverse Event (SAE) related to study drug or hematological and biochemical parameters from baseline until the end of study
- Changes in blood pressure from baseline [ Time Frame: 21 days ]Clinical evaluation of systolic and diastolic blood pressure changes from baseline until the end of study
- Changes in pulse from baseline [ Time Frame: 21 days ]Clinical evaluation of pulse values from baseline until the end of study
- Changes in respiratory rate from baseline [ Time Frame: 21 days ]Clinical evaluation of respiratory rate levels from baseline until the end of study
- Changes in fever from baseline [ Time Frame: 21 days ]Clinical evaluation of fever changes from baseline until the end of study
- Changes in oxygen saturation from baseline [ Time Frame: 21 days ]Clinical evaluation of oxygen saturation changes from baseline until the end of study
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04718285
Contact: Prof. Serdar Durdagi, Ph.D. | +90-216-579-8217 | serdar.durdagi@med.bau.edu.tr |
Turkey | |
Bahcesehir University, School of Medicine, Department of Biophysics, | Recruiting |
Istanbul, Turkey | |
Contact: Prof. Serdar Durdagi, Ph.D. +90-216-579-8217 serdar.durdagi@med.bau.edu.tr | |
Contact: durdagilab.com | |
Istanbul University, Cerrahpaşa School of Medicine | Recruiting |
Istanbul, Turkey |
Responsible Party: | Serdar Durdagi, Prof., Ph.D., Bahçeşehir University |
ClinicalTrials.gov Identifier: | NCT04718285 |
Other Study ID Numbers: |
MON786.168.1 |
First Posted: | January 22, 2021 Key Record Dates |
Last Update Posted: | April 28, 2022 |
Last Verified: | April 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Favipiravir |
Montelukast Anti-Asthmatic Agents Respiratory System Agents Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP1A2 Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |