ACTRN12620000982910.

Study name	A randomized double‐blind placebo‐controlled trial of oral ivermectin for outpatient treatment of those at high risk for hospitalization due to COVID‐19
Methods	Trial design: double‐blind RCT with 2 parallel arms Type of record: trial register entry Sample size: 400 Setting: outpatient Country: Australia Language: English Number of centres: NR Study purpose (treatment, prevention): treatment Trial registration number: ACTRN12620000982910 Date of registration: 14 September 2020
Participants	Inclusion criteria People aged ≥ 50 years who have tested positive for SARS‐CoV‐2 (by any nucleic acid amplification test/PCR‐based testing system recognized by public health authorities) within the preceding 12 days Are still symptomatic or have not yet developed symptoms Have any of the following risk factors: take medication for hypertension, take medication (oral or injectable) for blood glucose control, take medication for heart disease, take medication (oral or inhaled) for lung disease, currently smoke Are residing in the community Have at their current place of residence (i.e. at the location they are maintained in isolation) communication facilities necessary for trial functioning, these are: reliable mobile or landline telephone (or both) access, reliable access to email Capable of giving informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol Exclusion criteria Duration of symptoms ≥ 10 days AND symptoms clearly getting better Residents in an aged care facility (hostel or nursing home) or quarantine hotel Not usually fully independent in activities of daily living and self‐care including: washing, toileting, dressing, and dental care Current residence outside logistical boundaries of the study as defined from time to time during recruitment Self‐reported severe liver disease or cirrhosis, or both Use of warfarin Known allergy to Ivermectin Fit, seizure, or stroke in the last 6 months Dementia of any type Head injury requiring medical attention in the last 6 months Concussion in the last 6 months Current use of the following medications: verapamil, ciclosporin, cobicistat, ritonavir, ketoconazole, itraconazole, fusidic acid, erythromycin, clarithromycin Current use or use within the last 3 months of the medication: amiodarone Psychosocial illness which in the opinion of the investigative team would make successful trial completion (including follow‐up data collection) unlikely, for example including: uncontrolled substance use, homelessness, poorly controlled mental state disorder Inability to communicate in English to the level necessary to provide verbal consent and telephone call follow‐up data Current participation in another clinical drug trial for SARS‐CoV‐2
Interventions	Details of intervention Type and dose: ivermectin 0.2 mg/kg, single dose with the option of a second dose after 7 days Route of administration: oral Treatment details of control group Placebo Concomitant therapy: NA
Outcomes	Primary study outcome Proportions of participants progressing to hospitalization due to SARS‐CoV‐2 or death at 14 days Relevant review outcomes planned Proportions of participants progressing to hospitalization due to SARS‐CoV‐2 or death at 14 days Proportions of participants progressing to hospitalization or death at 7, 21, and 28 days Proportions of participants presenting to hospital with any of the following: clinical signs of respiratory distress (> 20 breaths/min) or oximetry desaturation (≤ 94%) (or both), clinical or radiological signs of pneumonia at 7, 14, 21, and 28 days Proportions of participants progressing to admission to ICU due to SARS‐CoV‐2 or death at 7, 21, and 28 days Proportion of participants progressing to death at 7, 14, and 21 days and up to 6 months Additional study outcomes Proportions of participants progressing to hospitalization or death at 7, 21, and 28 days Proportions of participants presenting to hospital with any of the following: clinical signs of respiratory distress (> 20 breaths/min) or oximetry desaturation (≤ 94%) (or both), clinical or radiological signs of pneumonia at 7, 14, 21, and 28 days Proportions of participants progressing to admission to ICU due to SARS‐CoV‐2 or death at 7, 21, and 28 days Proportions of participants progressing to requirement for intubation because of SARS‐CoV‐2 or death at 7, 21, and 28 days Duration of hospitalization of survivors within 7, 21, and 28 days and up to 6 months Duration of outpatient symptoms at 7, 21, and 28 days Proportion of participants progressing to death at 7, 14, and 21 days and up to 6 months
Starting date	15 February 2021
Contact information	Dr Mark Stein Department of Diabetes and Endocrinology Royal Melbourne Hospital 300 Grattan Street Victoria, 3050 Australia msteintpep1@florey.edu.au
Notes	Recruitment status: not yet recruiting Prospective completion date: NR Planned completion date more than 6 months ago: unclear Date last update posted: 27 January 2021 Sponsor/funding: The Leona M and Harry B Helmsley Charitable Trust (USA)