COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04718285

Prof. Serdar Durdagi, Ph.D.

serdar.durdagi@med.bau.edu.tr

2021-01-22

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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

- 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

3

Bahçeşehir University

18

100

Turkey

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

380

Hospitalized patient rates

None

Phase 2

[{"arm_notes": "", "treatment_id": 816, "treatment_name": "Montelukast", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 816, "treatment_name": "Montelukast", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]