Drug treatment, adverse event (AE) assessments, and follow-up
headache, fever
Participants were pretreated with IVM 150 μg/kg by mouth at least 6 months before the planned Part 2 study treatment to clear or reduce Mf counts in skin and eyes. A second IVM pretreatment was provided to all participants because of delayed regulatory approval for the Part 2 study and delays related to SARS-2-COVID lockdowns. The second IVM pretreatments were provided more than 1 year after the first pretreatment. The median interval between the second IVM pretreatment and the Part 2 study treatment was 7.3 weeks (range 1–28 weeks).Participants were transported from their home villages to the UHAS School of Public Health Research Centre (which is located within the grounds of the Hohoe Municipal Hospital) for Part 2 treatments and clinical evaluations. A study statistician prepared a random treatment allocation schedule and participants were randomized sequentially into one of the three treatment arms by the study pharmacist. The arms included a single dose of IVM 150 μg/kg plus ALB 400 mg fixed dose (IA), a single dose of IA plus DEC 6 mg/kg (IDA1), or three consecutive daily doses of IDA (IDA3). All treatments were oral and directly observed. Participants were evaluated daily for 7 days after treatment and asked whether they had symptoms suggestive of systemic (e.g., fever, headache), cutaneous, or ocular AEs. A study physician performed a directed physical examination for all participants. All participants had full ophthalmological examinations as described above on the day before treatment, on days 3 and 7 after treatment, and 3 months after treatment. A skin snip test was performed shortly before treatment, and this was repeated at 12 and 18 months after treatment.