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IRCT20200818048444N3 IRCT 2021-06-20 Ministry of Health Ivermectine effect in treatment and prophylaxis of patients and exposed idividuals with COVID-19 Ivermectine effect in treatment of patients with COVID-19 disease 2020-12-02 anticipated 25 Complete https://irct.ir/trial/52565 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: After determining the eligibility criteria and obtaining informed consent from patients, they will be assigned into the study groups using the Balanced Block Randomization method generated by the designer of the study. The size of the blocks and random sequence generation process will not be clarified for the principal investigator and other researchers so that the allocation concealment will be fully established. In addition, randomization efficacy will be tested at the end of the study and those confounding variables with imbalanced distribution across the study groups will be adjusted through the multivariable models. 1 Covid-19 Disease. Intervention 1: Intervention group: 3 doses of oral ivermectin 200 μg / kg once daily for 3 doses. Intervention 2: Control group: The patients in the control group will receive the standard treatment recommended by ministry of health for this disease. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after unidentified individuals. When: Spring 1400 To whom: Data is allowed for all researchers after submitting an access request and confirming it Conditions: In order to use the data, researchers must first identify and send the required items and data upon request, after which the data will be delivered. Where to obtain: By email dr.ansarin@gmail.com or postal code: 5142954481 How to obtain: The researcher must state his request in a letter. After agreeing to his request, the data will be emailed to him in Excel or Spss. Comments:
public Dr. Khalil Ansarin
Tuberculosis and Lung Diseases Research Center, Pashmineh Building, University St.
Tabriz Iran (Islamic Republic of) 5142954481 +98 41 3337 8093 dr.ansarin@gmail.com Tabriz University of Medical Sciences scientific Professor Khalil Ansarin
Tuberculosis and Lung Diseases Research Center, Pashmineh Building, Daneshgah Street
Tabriz Iran (Islamic Republic of) 5142954481 +98 41 3337 8093 dr.ansarin@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with diagnosis of COVID-19 disease no limit no limit Both History of allergy to ivermectin, and evidence for current helminthic disease Advanced renal failure with GFR<30 Advanced liver failure Advanced malignancy Severe heart failure or active cardiac arrhythmia U07.1 Covid-19 Disease Treatment - Drugs Treatment - Drugs Intervention group: 3 doses of oral ivermectin 200 μg / kg once daily for 3 doses Control group: The patients in the control group will receive the standard treatment recommended by ministry of health for this disease Patient mortality. Timepoint: Within 28 days after the onset of the disease. Method of measurement: Physician report. Transfer to ICU. Timepoint: Within 28 days after the onset of the disease. Method of measurement: Physician report. Intubation or mechanical ventilation. Timepoint: Within 28 days after the onset of the disease. Method of measurement: Physician report. Improve clinical symptoms. Timepoint: Start treatment up to 28 days. Method of measurement: Physician report. CRP value. Timepoint: Start treatment up to 28 days. Method of measurement: Measurements in serum. LDH value. Timepoint: Start treatment up to 28 days. Method of measurement: Measurements in serum. NLR value. Timepoint: Start treatment up to 28 days. Method of measurement: Measurement with CBCD. Ministry of Health Approved 2020-07-20 Regional Committee on Research Ethics (Studies in Human Subjects) No .2, Tabriz University of Medical Science. Golgasht st., Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)