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IRCT20111224008507N4 IRCT 2021-01-31 Mazandaran University of Medical Sciences Evaluation of the effect of Ivermectin in treatment of outpatients with COVID-19 Double-blind placebo-controlled clinical trial of evaluating the effectiveness of Ivermectin in treatment of outpatients with COVID-19 in 2021 2021-02-19 anticipated 1000 Complete https://irct.ir/trial/53949 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to two groups of intervention and control with 500 members using block randomization with block sizes of 4. Randomization will be done using the software randomization option in Excel. The randomization process is performed by the study methodology consultant and clinical researchers are not aware of the randomization process, Blinding description: After selecting the samples, none of the participant will be aware of randomization and allocation to groups. Physicians are given a table of pre-coded numbered numbers and patients are entered into the study in order of table numbers. Therefore, the present study is double-blind. Ivermectin and placebo tablets are the same shape, color and size and are 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 6 mg oral tablet at a dose of 0.4 mg/kg manufactured by Alborz Daru Co, 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 company 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: Everybody 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
Bouali Hospital, Pasdaran boulevard, Sari
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 2334 drmsrezaii@yahoo.com Mazandaran University of Medical Sciences scientific Dr. Mohammadsadegh 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 positive No need for hospitalization Weight >15 kg Age >5 years No treatment with antiviral drugs before and during the study Informed consent for inclusion 5 years no limit Both Underlying liver and kidney disease Patients with acquired immunodeficiency Pregnancy and lactation B34.2 Coronavirus infection, unspecified Treatment - Drugs Placebo Intervention group: The intervention group will use Iranian standard treatment protocol for COVID-19 in addition to Ivermectin 6 mg oral tablet at a dose of 0.4 mg/kg manufactured by Alborz Daru Co, 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 company of Iran with the same shape, color and weight based dose of ivermectin will be used for three days. Clinical improvement. Timepoint: Daily until improvement. Method of measurement: Clinical improvement is defined as reduction in persistent cough (more than one hour of excessive coughing, or 3 periods of coughing in 24 hours that disrupts daily life and ability to work) and tachypnea and O2 saturation above 94%. Negative PCR result. Timepoint: 6 days after intervention. Method of measurement: RT-PCR. The main complaints recovery time. Timepoint: Daily until symptoms resolve. Method of measurement: Checklist containing patient complaints. Need to be hospitalized. Timepoint: Daily until hospitalization or improvement. Method of measurement: Percentage of hospitalization and the interval from the beginning of the intervention to hospitalization. Mortality. Timepoint: Daily. Method of measurement: Record in checklist. Drug side effect. Timepoint: Daily. Method of measurement: Wheezing, itching, skin rash, edema, and hypotension are assessed daily. Mazandaran University of Medical Sciences Approved 2020-12-30 Ethics committee of Mazandaran University of Medical Sciences Vice chancellor for Research, Moallem square, Sari Sari Mazandaran Iran (Islamic Republic of)