At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection (COVID-19)
In Brief
A Phase 3 clinical trial evaluating Metformin, Placebo, and 2 other interventions for Covid19 and SARS-CoV Infection. Completed, enrolled 1,323 participants across 7 sites.
Detailed Summary
1. The purpose of this trial is to conduct a 2x3 factorial randomized trials, which efficiently allows the parallel conduct of three randomized trials to understand whether metformin, ivermectin, or fluvoxamine, is superior to placebo for preventing Covid-19 disease progression in non-hospitalized adults with SARS- CoV-2 infection. 2. To understand if the active treatment arms are superior to placebo in improving viral load, serologic markers associated with Covid-19, and gut microbiome in non-hospitalized adults with SARS-CoV-2 infection. 3. To understand if any of the active treatment arms prevent long-covid syndrome, PASC (post-acute sequelae of SARS-CoV-2 infection).
Study Details
Timeline
Interventions
Metformin; immediate release formation; 500mg on Day 1; 500mg BID on Day 2 through Day 5; 500mg in AM and 1,000mg in PM on Day 6 through Day 14.
placebo; appearance and size are exact matching to the three study drugs.
An antidepressant, administered 50mg per day on Day 1; then 50mg twice-daily for Day 2 through Day 14
An anti-parasitic medication administered as 390mcg/kg to 470mcg/kg per day for 3 days