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IRCT20200408046987N3 IRCT 2020-12-06 Akam Tejarat Fartak Farasoo Company Evaluation of prophylaxis induced by ivermectin in populations exposed to COVID-19 patients Evaluation of prophylaxis induced by ivermectin in populations exposed to COVID-19 patients 2020-11-30 anticipated 800 Complete https://irct.ir/trial/51999 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, simple randomization method will be used. A randomized list will be generated by online randomization site. Simple randomization will be generated with a computer from 1 to 800. The computer will divide the digits between the four groups. According to the sequences of admission, they will go to the control or the intervention group regarding the computerized random list, Blinding description: Participants will receive drug or placebo after signing the consent letter. Practitioner and consequence analyzer will not know about the treatment. Data analyzer will know the groups number only. 3 COVID-19. Intervention 1: Intervention group: : Ivermectin(200 mcg/Kg, PO, Once) to patient and Placebo(PO,Once) to other members of family. Intervention 2: Intervention group: Ivermectin(200 mcg/Kg, PO, Once) to other members of family and Placebo(PO,Once) to patient. Intervention 3: Intervention group: Ivermectin(200 mcg/Kg, PO, Once) to patient and other members of family. Intervention 4: Control group: Placebo(PO, Once) to patient and other members of family, placebo is made by Alborz Darou company including all Ivermectin ingredients except active ingredient. 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 Not decided yet
public Nematollah Gheibi
Bahonar Boulevard
Qazvin Iran (Islamic Republic of) 3741999184 +98 28 3332 8212 ngheibi@qums.ac.ir Qazvin University of Medical Sciences scientific Nematollah Gheibi
Bahonar Boulevard
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) Healthy individuals exposed directly and constantly with COVID-19 patients. COVID-19 patients who their disease is confirmed by RT-PCR test and low to moderate severity(Grade<3). Patients with O2 saturation>94 who fit outpatient protocol. Having consent for participating in study 18 years 65 years Both Pregnant or breastfeeding women individuals with a certain CNS disease Individuals with an uncontrolled disease(Asthma, COPD, cardiovascular disease, diabetes, Kidney or Liver dysfunction, Cancer, Hepatitis, AIDS, Immunodeficiency) Patients receiving immuno suppressive drugs individuals receiving any P-450 or P-gp blockers or any medication interacting with ivermectin patients under antiviral therapy individuals receiving any Corticosteroid(Inhaling, PO or Injection) any known sensitivity to Ivermectin or starch or history of lactose intolerability(for Placebo) individuals with positive SARS-CoV-2 specific antibody U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group: : Ivermectin(200 mcg/Kg, PO, Once) to patient and Placebo(PO,Once) to other members of family Intervention group: Ivermectin(200 mcg/Kg, PO, Once) to other members of family and Placebo(PO,Once) to patient Intervention group: Ivermectin(200 mcg/Kg, PO, Once) to patient and other members of family Control group: Placebo(PO, Once) to patient and other members of family, placebo is made by Alborz Darou company including all Ivermectin ingredients except active ingredient Percentage of patients in family members. Timepoint: The day of zero and 3 days after taking the drug, then every week for a month (until complete recovery of family members)days 0, 3, 7, 14, 21, 28. Method of measurement: Follow-up and questionnaire from the patient about the symptoms of the Covid 19. Duration of illness. Timepoint: The day of zero and 3 days after taking the drug, then every week for a month (until complete recovery of family members)days 0, 3, 7, 14, 21, 28. Method of measurement: Follow-up and questionnaire from the patient about the symptoms of the Covid 19. Severity of disease. Timepoint: The day of zero and 3 days after taking the drug, then every week for a month (until complete recovery of family members)days 0, 3, 7, 14, 21, 28. Method of measurement: Follow-up and questionnaire from the patient about the symptoms of the Covid 19. Considering the drug side effects during the study. Timepoint: 3 days after taking the drug, then every week for a month (until complete recovery of family members)days 0, 3, 7, 14, 21, 28. Method of measurement: Follow-up and questionnaire from the patient about the symptoms of the Covid 19. Considering the changes in serum antibody level of IgA. Timepoint: The day of zero and 3 days after taking the drug, then every week for a month (until complete recovery of family members)days 0, 3, 7, 14, 21, 28. Method of measurement: Serologic test-ELISA. Considering the changes in serum antibody levels of IgM. Timepoint: The day of zero and 3 days after taking the drug, then every week for a month (until complete recovery of family members)days 0, 3, 7, 14, 21, 28. Method of measurement: Serologic test-ELISA. Considering the changes in serum antibody levels of IgG. Timepoint: The day of zero and 3 days after taking the drug, then every week for a month (until complete recovery of family members)days 0, 3, 7, 14, 21, 28. Method of measurement: Serologic test-ELISA. Duration of the illness with recheck of Rt-PCR at days. Timepoint: The day of 3 and 7 after taking the drug. Method of measurement: Rt-PCR test. Akam Tejarat Fartak Farasoo Company Approved 2020-10-04 Qazvin university of medical sciences Bahonar Boulevard Qazvin Qazvin Iran (Islamic Republic of)