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IRCT20200408046987N1 IRCT 2020-04-27 Chistasazan Notash Fartak Company Limited. Dose-Finding Study of Ivermectin in the Treatment of COVID-19 Dose-Finding study of Ivermectin treatment on patients infected with Covid-19:A clinical trial 2020-05-04 anticipated 125 Complete https://irct.ir/trial/47012 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple randomization method will be used. A randomized list will be generated by online randomization site. Patients will be allocated to case or control group according to the generated list, Blinding description: Participants will receive drug or placebo after signing the consort letter. Practitioner and consequence analyzer will not know about the treatment. Data analyzer will know the groups number only. 3 COVID-19. Intervention 1: Control group: Standard regimen based on Iran health ministry. Intervention 2: Intervention group: Standard regimen based on Iran health ministry plus low dose Ivermectin(200 mcg/kg , PO, Once). Intervention 3: Intervention group: Standard regimen based on Iran health ministry plus high dose Ivermectin(200 mcg/kg , PO, interval days:1,2,5). Intervention 4: Control group: Standard regimen based on Iran health ministry plus Placebo,Once in first day. placebo is a simple tablet containing only fillers without any active ingredient and is made by Alborz Darou company. Intervention 5: Intervention group: 400 mcg/kg in day1 followed by 200 mcg/kg in day 2 and day 5. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Extra data unavailable
public Nematollah Gheibi
Shaid Bahonar Blvd.
Qazvin Iran (Islamic Republic of) 3741999184 +98 28 3332 8212 ngheibi@qums.ac.ir Qazvin University of Medical Sciences scientific Nematollah Gheibi
Shaid Bahonar Blvd.
Qazvin Iran (Islamic Republic of) 3741999184 +98 28 3332 8212 ngheibi@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patients who test positive for COVID-19 by a commercially available Test Patients ≥ 20 but < 65 years of age with a temperature (oral) of 38°C patients 65 - 80 years of age with a temperature (oral) of 37.8°C Patients with 2 or more of the following symptoms (moderate to severe in intensity) at the time of enrollment: Cough Sore throat Headache Nasal congestion Feeling feverisho Body aches and pains Fatigue (tiredness) 20 years 80 years Both U07.1 COVID-19 Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: Standard regimen based on Iran health ministry Intervention group: Standard regimen based on Iran health ministry plus low dose Ivermectin(200 mcg/kg , PO, Once) Intervention group: Standard regimen based on Iran health ministry plus high dose Ivermectin(200 mcg/kg , PO, interval days:1,2,5) Control group: Standard regimen based on Iran health ministry plus Placebo,Once in first day. placebo is a simple tablet containing only fillers without any active ingredient and is made by Alborz Darou company. Intervention group: 400 mcg/kg in day1 followed by 200 mcg/kg in day 2 and day 5 Chest image(CT scan). Timepoint: at hospital clearance. Method of measurement: Patient's profile(CT scan image). Hospitalization time. Timepoint: end of intervention. Method of measurement: Hospitalization time. CBC and CRP. Timepoint: Before intervention, 7 days after intervention. Method of measurement: Sampling and lab test. Chistasazan Notash Fartak Company Limited. Approved 2020-04-21 Qazvin University of Medical Sciences Bahonr Blvd. Qazvin University of Medical Sciences Qazvin Qazvin Iran (Islamic Republic of) Approved 2020-06-09 Qazvin University of Medical Sciences Bahonr Blvd. Qazvin University of Medical Sciences Qazvin Qazvin Iran (Islamic Republic of)