NCT04438850.

Study name	COVidIVERmectin: ivermectin for treatment of COVID‐19 (COVER)
Methods	Trial design: triple‐blind RCT with 3 parallel arms Type of record: trial register entries Sample size: 102 Setting: outpatient Country: Italy Language: English Number of centres: 5 Study purpose (treatment, prevention): treatment Trial registration number: NCT04438850 Date of registration: 19 June 2020
Participants	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 diseases 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: Intervention 1: ivermectin 0.6 mg/kg, once daily for 5 days Intervention 2: 1.2 mg/kg, once daily for 5 days Route of administration: oral Treatment details of control group Placebo Concomitant therapy: NA
Outcomes	Primary study outcome Number of serious adverse drug reaction at 14 days Viral load at 7 days Relevant review outcomes planned Number of serious adverse drug reaction at 14 days Proportion of participants with virological clearance at 14 days Hospitalization rate within 14 days Additional study outcomes Trend over time of quantitative viral load at 7 and 14 days measured by quantitative, digital droplet PCR. Time to clinical resolution (for symptomatic participants) within 14 and 30 days Time from diagnosis to documented viral clearance within 14 and 30 days Proportion of participants with virological clearance at 30 days Severity score at 14 and 30 days Hospitalization rate within 30 days
Starting date	31 July 2020
Contact information	Zeno Bisoffi, PhD IRCCS  Sacro Cuore Don Calabria hospital Negrar, Verona 37024 Italy zeno.bisoffi@sacrocuore.it
Notes	Recruitment status: recruiting Prospective completion date: September 2021 Date last update posted: 17 May 2021 Sponsor/funding: IRCCS Sacro Cuore Don Calabria di Negrar