Bounfrate 2021.

Study characteristics
Methods	Trial design: triple‐blind RCT with 3 parallel arms, the 2 intervention arms were pooled for this review Type of publication: pre‐proof journal publication Setting: outpatient Recruitment dates: July 2020 to May 2021 Country: Italy Language: English Number of centres: 4 Study purpose (treatment, prevention): treatment Trial registration number: NCT04438850 Date of registration: 19 June 2020
Participants	Number of participants (randomized/analysed): 93/89 Age (median): overall 47 years Males, n: overall 54 (58%) Severity of condition according to study definition: mild disease, defined as not requiring hospitalization or oxygen supplementation Severity of condition according to WHO scale: 1 to 3 Time from symptom onset to enrolment (median): overall 4 (IQR 3 to 5.5) days Comorbidities: any pre‐existing condition, obesity, diabetes, cardiovascular disease, respiratory disease Virus detection performed at baseline (test‐positive at baseline): RT‐PCR (100%) Vaccination status: overall 91 (98%) participants without any vaccination Inclusion criteria: age ≥ 18 years; positivity for SARS‐CoV‐2 (nasopharyngeal swabs) by RT‐PCR; consent to participating in the study and to the processing of personal data; COVID‐19 Severity Score < 3; participant able to take oral drugs Exclusion criteria: pregnant or lactating women (pregnancy test not required, if doubt person is excluded); people with known central nervous system disease; lack of (or inability to provide) informed consent; receiving dialysis; any severe medical condition with a prognosis of < 6 months; receiving warfarin treatment; receiving antiviral treatment; receiving chloroquine phosphate or hydroxychloroquine
Interventions	Details of intervention Type and dose: ivermectin 0.6 mg/kg and 1.2 mg/kg (pooled), once daily for 5 days Route of administration: oral Treatment details of control group Placebo Concomitant therapy: NA Duration of follow‐up: 30 days Treatment cross‐overs: none
Outcomes	Primary study outcome Number of serious adverse drug reaction within 14 days Viral load at 7 days Relevant review outcomes reported Symptom resolution at 14 and 30 days Hospitalization rate within 30 days Mortality rate at 30 days (outcome provided by study author via personal communication) Proportion of participants with virological clearance at 14 days (detailed data provided by study author via personal communication) Serious adverse events within 30 days (outcome provided by study author via personal communication) Any adverse events within 30 days (number of participants with any adverse event provided by study author via personal communication) Additional study outcomes reported Trend over time of quantitative viral load at 7, 14 and 30 days measured by quantitative, digital droplet PCR Time to clinical resolution (for symptomatic participants) within 14 and 30 days Proportion of participants with virological clearance at day 30 COVID‐19 Severity Score at 14 and 30 days
Notes	Date of pre‐proof publication: 22 December 2021 Sponsor/funding: Italian Ministry of Health and Insud Pharma Correspondence with the author team: author request sent (review relevant outcome data, number of analysed participants); response received from author Information on ethics votum: ethics committee approval number reported by a nationally‐recognized ethics committee, as defined in the country's clinical trial regulations