IRCT20200408046987N3.

Methods	Trial design: double‐blind RCT with 4 parallel arms; 2 arms investigate prevention, 2 arms investigate treatment Type of record: trial register entry Sample size: 800 Setting: after high‐risk exposure Country: Iran Language: English Number of centres: 1 Study purpose (treatment, prevention): prevention Trial registration number: IRCT20200408046987N3 Date of registration: 6 December 2020
Participants	Inclusion criteria Healthy people exposed directly and constantly to people with COVID‐19 (whose disease is confirmed by RT‐PCR test and low‐to‐moderate severity (Grade < 3). People with SpO2 > 94% who fit outpatient protocol) Giving consent for participating in study Exclusion criteria Pregnant or breastfeeding women People with certain central nervous system disease People with an uncontrolled disease (asthma, COPD, cardiovascular disease, diabetes, kidney or liver dysfunction, cancer, hepatitis, AIDS, immunodeficiency) People receiving immunosuppressive drugs People receiving any P‐450 or P‐gp blockers or any medication interacting with ivermectin People receiving antiviral therapy People receiving any corticosteroid (inhaled, oral, or injection) Any known sensitivity to ivermectin or starch or history of lactose intolerability (for placebo) People with positive SARS‐CoV‐2‐specific antibody
Interventions	Details of intervention for relevant arms Type and dose: ivermectin 0.2 mg/kg, single dose Route of administration: oral Treatment details of control group Placebo Concomitant therapy: index patient receives placebo in both relevant arms
Outcomes	Primary study outcome Percentage of participants in family members at day 0, 3, 7, 14, 21, 28 Duration of illness at day 0, 3, 7, 14, 21, 28 Severity of disease at day 0, 3, 7, 14, 21, 28 Relevant review outcomes planned Drug adverse effects during the study at day 0, 3, 7, 14, 21, 28 Duration of the illness with recheck of RT‐PCR at 3 and 7 days Additional study outcomes Considering the changes in serum antibody level of IgA, IgM and IgG Drug adverse effects during the study at day 0, 3, 7, 14, 21, 28
Notes	Reason for awaiting classification: unclear study description regarding main rationale of the study: postexposure prophylaxis or treatment (intervention arms are partially for treatment, outcomes are mainly focused on the index patient); study completed, but results not published yet Recruitment status: completed Prospective completion date: December 2020, study completed Planned completion date more than 6 months ago: yes Date last update posted: 6 December 2020 Sponsor/funding: Akam Tejarat Fartak Farasoo Company