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IRCT20200506047323N6 IRCT 2020-11-17 Bandare-abbas University of Medical Sciences Effect of Ivermectin in treatment of COVID-19 The efficacy and safety of Ivermectin in patients with COVID-19: a randomized clinical trial 2020-11-15 anticipated 120 Complete https://irct.ir/trial/49501 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients in both hospitalized (moderate) and outpatient (mild) groups will be randomized into the treatment and control groups based on the following method. Simple randomization method and table of random numbers will be used. If selected number is even, the patient is allocated to treatment group, and if it is odd, the patient is allocated to control group. 3 COVID-19 disease. Intervention 1: Intervention group: will be mild patients receiving hydroxychloroquine sulfate (Amin Pharmaceutical company, Iran) at a dose of 400 mg twice a day for the first day and 200 mg twice a day for six following days, along with oral Ivermectin (MSD company, France) at a single dose of 0.2 mg/kg. Intervention 2: Control group: will be mild patients receiving hydroxychloroquine sulfate (Amin Pharmaceutical company, Iran) at a dose of 400 mg twice a day for the first day and 200 mg twice a day for six following days. Intervention 3: Intervention group: will be moderate patients receive 200/50 mg Lopinavir/Ritonavir (Heterd company, India) twice a day for the seven days, plus five doses of 44 mcg Interferon beta-1a (CinnaGen, Iran) every other day, plus oral Ivermectin (MSD company, France) at a single dose of 0.2 mg/kg. Intervention 4: Control group: will be moderate patients receive 200/50 mg Lopinavir/Ritonavir (Heterd company, India) twice a day for the seven days, plus five doses of 44 mcg Interferon beta-1a (CinnaGen, Iran) every other day. Yes - There is a plan to make this available What will be shared: Information regarding the study outcomes will be shared. When: Data will become available after publication of obtained results To whom: Only academic institutions Conditions: The study protocol or proposal should be approved by Ethics committee of institutions. The rights of authors and sponsors should be respected. Where to obtain: M.fathalipour@yahoo.com How to obtain: َA request should be addressed to the Technology and Research Vice-chancellery of Hormozgan University of Medical Sciences and the project executor should informed. Comments:
public Mohammad Fathalipour
Emam Hossein Blvd
Bandar Abbas Iran (Islamic Republic of) 7919691982 +98 76 3371 0406 m.fathalipour@hums.ac.ir Bandare-abbas University of Medical Sciences scientific Mohammad Fathalipour
Emam Hossein Blvd
Bandar Abbas Iran (Islamic Republic of) 7919691982 +98 76 3371 0406 m.fathalipour@hums.ac.ir Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Age ≥20 years old Weight ≥35 kg Positive polymerase chain reaction (PCR) test for COVID-19 Non-hospitalized mild as well as hospitalized moderate patients Signed informed consent voluntarily and knowingly 20 years no limit Both Underlying diseases (AIDS, asthma, severe liver and kidney disease) History of Loiasis History of drug allergy to Ivermectin Use of anticoagulants (e.g. warfarin) and ACE inhibitors (e.g. captopril) Pregnancy or breastfeeding U07.2 COVID-19, virus not identified Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: will be mild patients receiving hydroxychloroquine sulfate (Amin Pharmaceutical company, Iran) at a dose of 400 mg twice a day for the first day and 200 mg twice a day for six following days, along with oral Ivermectin (MSD company, France) at a single dose of 0.2 mg/kg. Control group: will be mild patients receiving hydroxychloroquine sulfate (Amin Pharmaceutical company, Iran) at a dose of 400 mg twice a day for the first day and 200 mg twice a day for six following days. Intervention group: will be moderate patients receive 200/50 mg Lopinavir/Ritonavir (Heterd company, India) twice a day for the seven days, plus five doses of 44 mcg Interferon beta-1a (CinnaGen, Iran) every other day, plus oral Ivermectin (MSD company, France) at a single dose of 0.2 mg/kg. Control group: will be moderate patients receive 200/50 mg Lopinavir/Ritonavir (Heterd company, India) twice a day for the seven days, plus five doses of 44 mcg Interferon beta-1a (CinnaGen, Iran) every other day. Length of hospital stay. Timepoint: Until discharge date. Method of measurement: Questionnaire. Need for ICU. Timepoint: Until discharge date. Method of measurement: Questionnaire. Need for mechanical ventilation. Timepoint: Until discharge date. Method of measurement: Questionnaire. Incidence of serious adverse reactions. Timepoint: Before intervention and daily during the study. Method of measurement: Questionnaire. Bandare-abbas University of Medical Sciences Approved 2020-11-15 Ethics committee of Hormozgan University of Medical Sciences Jomhuri Eslami Blvd Hormozgan Hormozgan Iran (Islamic Republic of)