PACTR202102848675636.

Study name	Double blind, community‐based, randomized controlled trial on the use of ivermectin as post exposure chemo‐prophylaxis for COVID‐19 among high risk individuals in Lagos (IVERPEPCOV) COVID‐19
Methods	Trial design: double‐blind RCT with 6 parallel arms Type of record: trial register entry Sample size: 2000 Setting: after high‐risk exposure Country: Nigeria Language: English Number of centres: 2 Study purpose (treatment, prevention): prevention Trial registration number: PACTR202102848675636 Date of registration: 11 February 2021
Participants	Inclusion criteria Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Men or women, aged 18–85 years Close contacts (6 m with no personal protective equipment) to confirmed RT‐PCR‐positive individual Ability to take oral medication and be willing to adhere to the study regimen Women of reproductive potential: negative pregnancy test and last menstrual period date Agreement to adhere to lifestyle considerations throughout study duration Exclusion criteria Current use of cytochrome P4 enzyme inducers such as azole group of oral antifungal medication (ketoconazole, itraconazole), warfarin Non‐exposure to people with COVID‐19 Refuse to give informed consent Pregnant and lactating women Known hypersensitivity to ivermectin Have had treatment with any investigational drug within 2 weeks prior to randomization Children, stigmatized population, institutionalized people Previously diagnosed and recovered from COVID‐19 Severely‐ill people such as those on ventilators, hepatic or renal impairment, or unconscious People receiving drugs that can have serious interactions with the trial drug including barbiturates (e.g. asphennobarbital, butalbital), benzodiazepines (e.g. clonazepam, lorazepam), sodium oxybate (gamma‐hydroxybutyrate), valproic acid and herbal medicines Treatment with another investigational drug
Interventions	Details of intervention Type and dose Intervention 1: ivermectin 0.2 mg/kg, once weekly for 4 weeks Intervention 2: ivermectin 0.2 mg/kg, alternate week for 2 doses Intervention 3: ivermectin 0.2 mg/kg, once monthly for 3 months Route of administration: oral Treatment details of control group 3 placebo regimens according to each intervention arm Concomitant therapy NA
Outcomes	Primary study outcome Number developing COVID‐19 clinical disease at 14 days, subsequently confirmed by RT‐PCR Relevant review outcomes planned Number developing COVID‐19 clinical disease at 14 days, subsequently confirmed by RT‐PCR Number with serious adverse outcome within the study period Number developing severe or critical COVID‐19 Additional study outcomes Number with serious adverse outcome within the study period Number developing severe or critical COVID‐19
Starting date	8 March 2021
Contact information	Olufemi Babalola Department of Surgery Bingham University Karu Lagos Nigeria bablo57@gmail.com
Notes	Recruitment status: not yet recruiting Prospective completion date: October 2021 Planned completion date more than 6 months ago: no Date last update posted: 31 October 2021 Sponsor/funding: Federal Government of Nigeria