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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200408046987N3
Enrollment
800
Registered
2020-12-06
Start date
2020-11-30
Completion date
Unknown
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19. COVID-19, virus identified

Interventions

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)

Sponsors

Akam Tejarat Fartak Farasoo Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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(Grade94 who fit outpatient protocol. Having consent for participating in study

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNematollah Gheibi

Qazvin University of Medical Sciences

ngheibi@qums.ac.ir+98 28 3332 8212

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026