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Clinical trialNCT04510194CompletedPhase 3Interventional

COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection (COVID-19)

SponsorUniversity of MinnesotaEnrollment1,323Covid19SARS-CoV Infection
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Olive View Ucla Medical Center

    Sylmar, California, United States

  • University of Colorado Denver; Department of Medicine; Anschutz Health and Wellness Center

    Aurora, Colorado, United States

  • New West Physicians

    Golden, Colorado, United States

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, United States

  • American Health Network of Indiana

    Greenfield, Indiana, United States

  • Hennepin County Medical Center

    Minneapolis, Minnesota, United States

  • University of Minnesota

    Minneapolis, Minnesota, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
1 Jan 2021
Primary completion
14 Dec 2022
Completion
14 Dec 2022
Last update posted
24 Apr 2026
Registered enrollment
1,323
Registry id
NCT04510194

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.