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IRCT20111224008507N5 IRCT 2021-02-22 Mazandaran University of Medical Sciences Evaluation of the effect of Ivermectin in treatment of patients admitted with COVID-19 Double-blind placebo-controlled clinical trial of evaluating the effectiveness of Ivermectin in treatment of patients admitted with COVID-19 in 2021 2021-02-19 anticipated 1000 Complete https://irct.ir/trial/54402 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, using the Random number generation plugin in excel software, a table of random numbers from 1 to 1000 is prepared in a non-sequential and scattered manner, and the numbers are assigned to two intervention and control groups of 500 cases. The randomization process is performed by the methodology consultant and clinical researchers are not aware of the randomization process and will only be provided with random codes from 1 to 1000, Blinding description: After selecting the samples, none of the participants will be aware of randomization and allocation to groups. Physicians will be given a table of pre-coded numbered numbers and patients will be entered into the study in order of table numbers. Therefore, the present study will be double-blind. Ivermectin and placebo tablets will be in the same shape, color and size and will be delivered to the patient/parents in a package. 3 COVID-19 infection. Intervention 1: Intervention group: The intervention group will use Iranian standard treatment protocol for COVID-19 in addition to Ivermectin 3 mg oral tablet at a dose of 0.4 mg/kg manufactured by Alborz Daru of Iran for 3 days as follows: weight 15-24, 6 mg; Weight 35-25, 12 mg; Weight 50-36, 18 mg; Weight 80-5, 24 mg and weight over 80, 0.4 mg/kg. Intervention 2: Control group: In the control group, placebo tablets made by Alborz Daru of Iran with the same shape, color and weight based dose of ivermectin will be used for three days. Yes - There is a plan to make this available What will be shared: Part of the data is accessible When: Starting in January 2022 To whom: Physicians Conditions: Systematic review articles Where to obtain: Contact Dr. Mohammad Sadegh Rezai. E-mail: drmsrezaii@yahoo.com How to obtain: After contact, information is sent within a few days Comments:
public Dr Mohammad Sadegh Rezai
Boali Hospital, Pasdaran Blv., Sari
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 2334 drmsrezaii@yahoo.com Mazandaran University of Medical Sciences scientific Dr Mohammad Sadegh Rezai
Bouali Hospital, Pasdaran Boulevard, Sari
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 2334 drmsrezaii@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with positive coronavirus rapid test or RT-PCR Age>5 years Weight >15 kg No treatment with antiviral drugs before and during the study Informed consent for participation 5 years no limit Both Underlying liver and kidney disease Patients with acquired immunodeficiency Pregnancy and lactation U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: The intervention group will use Iranian standard treatment protocol for COVID-19 in addition to Ivermectin 3 mg oral tablet at a dose of 0.4 mg/kg manufactured by Alborz Daru of Iran for 3 days as follows: weight 15-24, 6 mg; Weight 35-25, 12 mg; Weight 50-36, 18 mg; Weight 80-5, 24 mg and weight over 80, 0.4 mg/kg Control group: In the control group, placebo tablets made by Alborz Daru of Iran with the same shape, color and weight based dose of ivermectin will be used for three days. Reduction in persistent cough. Timepoint: Daily until improvement. Method of measurement: Question from the patient. Negative RT-PCR result. Timepoint: 6 days after the intervention. Method of measurement: RT-PCR. The main complaints recovery time. Timepoint: Daily until symptoms resolve. Method of measurement: Checklist containing patient complaints. Mortality. Timepoint: Daily. Method of measurement: Record in checklist. Drug side effect (Wheezing, itching, skin rash, edema, and hypotension). Timepoint: Daily. Method of measurement: Question from the patient. Reduction in tachypnea. Timepoint: Daily. Method of measurement: Medical record. Oxigen saturation >94%. Timepoint: Daily. Method of measurement: Medical record. Mazandaran University of Medical Sciences Approved 2021-01-27 Ethics committee of Mazandaran University of Medical Sciences Vice chancellor for Research, Moallem square, Sari Sari Mazandaran Iran (Islamic Republic of)