NCT04703205.

Study name	Study in COvid‐19 Patients With iveRmectin (CORVETTE‐01)
Methods	Trial design: double‐blind RCT with 2 parallel arms Type of record: trial register entries Sample size: 240 Setting: outpatient Country: Japan Language: English Number of centres: 1 Study purpose (treatment, prevention): treatment Trial registration number: NCT04703205 Date of registration: 11 January 2021
Participants	Inclusion criteria Diagnosed with COVID‐19 (including asymptomatic) by PCR test (SARS‐CoV‐2 nucleic acid detection) within 3 days before the qualification test SaO2 in room air ≥ 95% Age ≥ 20 years at time of obtaining consent Weight ≥ 40 kg at time of qualification test Understanding the content of this clinical trial and can obtain written consent to participate in the clinical trial Exclusion criteria Pregnant or breastfeeding women, or unwilling to prevent pregnancy by medically appropriate means for up to 7 days after study drug administration. Medically appropriate contraception means using a combination of ≥ 2 of the following: not having sexual intercourse, taking surgical sterilization such as vasectomy or intrauterine device, taking oral contraceptive, using condoms Severe liver damage (AST or ALT at the time of qualification test is > 3 times the upper limit of institutional standard and total bilirubin is > 2 times upper limit of institutional standard value), renal disorder (estimated GFR of eligibility test value ≤ 30 mL/minute/1.73m2) Hypersensitivity to ivermectin History of severe drug allergies such as Stevens‐Johnson syndrome, toxic epidermal necrolysis Received prespecified prohibited medication within the past month (within the past 6 months for biologicals), or those who need to use prespecified prohibited medication during the clinical trial period Participating in other clinical trials or who have participated in other clinical trials within 30 days before obtaining consent Person considered unsuitable for this clinical trial by the principal investigator
Interventions	Details of intervention Type and dose: ivermectin 0.2 mg/kg, single dose Route of administration: oral Treatment details of control group Placebo Concomitant therapy: NA
Outcomes	Primary study outcome Period until the COVID‐19 PCR test (SARS‐CoV‐2 nucleic acid detection) becomes negative within 14 days Relevant review outcomes planned Period until the COVID‐19 PCR test (SARS‐CoV‐2 nucleic acid detection) becomes negative within 14 days Additional study outcomes None
Starting date	16 September 2020
Contact information	Kunihiro K Yamaoka, PhD Kitasato University Sagamihara Kanagawa Japan yamaoka@med.kitasato‐u.ac.jp
Notes	Recruitment status: recruiting Prospective completion date: May 2022, postponed from May 2021 Planned completion date more than 6 months ago: no Date last update posted: 26 October 2021 Sponsor/funding: Kitasato University