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IRCT20181208041886N3 IRCT 2020-12-22 Abidi Pharmaceutical company The effect of Montelukast on COVID 19 disease activity Evaluation of the effect of Montelukast drug in improving the clinical condition of patients with COVID-19 in referral hospitals in Isfahan 2020-12-21 anticipated 60 Complete https://irct.ir/trial/51633 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: At first 15 block will be designed and these blocks, will divided to 3 groups as the mild (blocks 1 to 5 for patients with mild disease), moderate (blocks 6 to 10 for patients with moderate disease) and sever blocks (blocks 11 to 15 for patients with severe disease). After this designation in every block 4 blank will be designed for the patients as below: Blank 1: Intervention by drug (Montelukast) Blank 2: No intervention by the drug Blank 3: Intervention by the drug (Montelukast) Blank 4: No intervention by the drug In approach to every patient (out patient and/or inpatient) at first he/she will be selected on the inclusion and exclusion criteria and after getting informed consent he/she will be classified as the patient with mild, moderate and sever disease. Then the patient will be placed in the empty blank in his/her own block and will and /or will not take the drug (Montelukast) as the previous designation, Blinding description: In this study the patients and the physician who evaluate the signs and symptoms of the patients are blinded about the therapy. To prevent of the bias the montelukast tablet will be give the patients accompanied with other drugs. on the other hand the assessor also will not be informed about the drugs of the patients. 3 COVID-19. Intervention 1: Intervention group: the patients with diagnosis of COVID-19 will be treated by tablet Montelukast 10 mg. This treatment will be in addition to standard therapies for these patients. The drug is in tablet and oral form which will be administered once a day and for 14 days. We will use Airokast tablet which is made by Dr. Abidi pharmaceutical company in Iran. Intervention 2: Control group: the patient with diagnosis of COVID-19 will give the standard therapies and without Montelukast. Yes - There is a plan to make this available What will be shared: the article from this study will be distributed about the effect of Montelukast in treatment of the patients with COVID-19 infection. When: immediately after article publish To whom: Every body Conditions: No condition except the conditions of the publisher Where to obtain: the article which will be published How to obtain: the procedure which will be prescribed by the publisher Comments: No comment
public Morteza Pourahmad
Sofeh Street
Isfahan Iran (Islamic Republic of) 8189111491 +98 31 3322 0996 mortezapourahmad@yahoo.com Esfahan University of Medical Sciences scientific Morteza Pourahmad
Sofeh street
Isfahan Iran (Islamic Republic of) 8189111491 +98 31 3322 0996 Mortezapourahmad@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Every patient with diagnosis of COVID-19 Mild, moderate and severe stage of the disease 15 years no limit Both No complete consent and compliace of the patient for study Follow up of the patient not be possible The age below 15 years old Rifampin and Phenobarbital consumers U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: the patients with diagnosis of COVID-19 will be treated by tablet Montelukast 10 mg. This treatment will be in addition to standard therapies for these patients. The drug is in tablet and oral form which will be administered once a day and for 14 days. We will use Airokast tablet which is made by Dr. Abidi pharmaceutical company in Iran. Control group: the patient with diagnosis of COVID-19 will give the standard therapies and without Montelukast. Discontinuation of fever. Timepoint: Daily till 14 days. Method of measurement: Measurement of temperature by digital infrared thermometer, and the O2 saturation by pulseoximeter. Decreased Respiratory Rate. Timepoint: Daily till 14 days. Method of measurement: Measurement of fever by a termometer, and O2 saturation by pulse Oximetery. Decreased Cough. Timepoint: Daily till 14 days. Method of measurement: Body temperature by thermometer, O2 sat by pulseoximetery. Evaluation of blood O2 Saturation. Timepoint: Daily till 14 days. Method of measurement: Physician evaluation by Puls oxymetery. Improvement of the patient with diagnosis of COVID-19 infection. Timepoint: Daily till 14 days. Method of measurement: Evaluation by Physician. Abidi Pharmaceutical company Approved 2020-08-09 Ethics committee of Isfahan University of Medical Sciences Sofeh Street Isfahan Isfehan Iran (Islamic Republic of)