NCT04510194.

Study name	COVID‐OUT: Early Outpatient Treatment for SARS‐CoV‐2 Infection (COVID‐19)
Methods	Trial design: randomised, triple‐blinded Type of record: trial register entry and published protocol Sample size: 1350 Setting: outpatients Country: Canada, USA Language: English Number of centres: 5 Trial registration number: NCT04510194 Date of trial registration: 12 August 2020
Participants	Inclusion Criteria Both male and female aged 30 years to 85 years Positive laboratory test for active SARS‐CoV‐2 viral infection based on local laboratory standard (PCR) No known history of confirmed SARS‐CoV‐2 infection Electronic device for communication Exclusion Criteria Hospitalised, for COVID‐19 or other reasons History of severe kidney disease Unstable heart failure
Interventions	Details of intervention Eligible patients shall be randomised to receive one of the antibiotics/combinations. metformin only fluvoxamine only ivermectin only metformin + fluvoxamine metformin + ivermectin Route of administration: oral Treatment details of control group (e.g. dose, route of administration) Placebo
Outcomes	Primary study outcomes clinical progression at 14 days; defined as emergency department visit for any COVID‐19 related symptom (including hospitalisation or death) or decrease in O2 saturation (≤ 93% on room air, or need for supplemental oxygen to maintain an O2 saturation > 93%) Relevant review outcomes planned quality of life hospitalisation or death Secondary outcome maximum symptom severity at 14 days and 28 days clinical progression at 14 days and 28 days time to meaningful recovery at 14 days and 28 days
Starting date	1 January 2021
Contact information	covidout@umn.edu
Notes	Recruitment status: recruiting Prospective completion date: February 2023 Date last update was posted: 16 January 2022 Sponsorship/funding source: University of Minnesota