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NCT04510194 · ClinicalTrials.gov registry record · Phase 3
COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection (COVID-19)
A Phase 3 study of Covid19 and SARS-CoV Infection, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,323
- Enrollment target
- 7
- Study locations
NCT04510194 is a Phase 3 study of Covid19 and SARS-CoV Infection that has completed, run by University of Minnesota. The registered enrollment target is 1,323 participants, below the 2,688-participant average among 94 other Covid19 trials with a reported enrollment target (51% lower). The trial reports 7 study locations across 5 states.
The verdict
NCT04510194, a Phase 3 study of Covid19 and SARS-CoV Infection, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,323 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this trial is to understand whether: 1. Metformin vs fluvoxamine vs ivermectin vs metformin+fluvoxamine vs metformin+ivermectin is superior to placebo in non-hospitalized adults with SARS-CoV-2 disease for preventing Covid-19 disease progression. 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).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ivermectin
- DRUG Metformin
- DRUG Fluvoxamine
Study Locations (7)
Colorado
- University of Colorado Denver; Department of Medicine; Anschutz Health and Wellness Center - Aurora
- New West Physicians - Golden
Minnesota
- Hennepin County Medical Center - Minneapolis
- University of Minnesota - Minneapolis
California
- Olive View UCLA Medical Center - Sylmar
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
Indiana
- American Health Network of Indiana - Greenfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,323 participants |
| Start Date | 2021-01-01 |
| Est. Completion | 2022-02-14 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04510194
The ClinicalTrials.gov registry entry for NCT04510194 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,323 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,688-participant average among 94 other Covid19 trials with a reported enrollment target (51% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Covid19 appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT04510194 reports 7 study locations spanning 5 distinct geographic areas - top geographies include Colorado, Minnesota, California.
Frequently Asked Questions
What is clinical trial NCT04510194 about?
NCT04510194 is a clinical study titled "COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection (COVID-19)". The purpose of this trial is to understand whether: 1. Metformin vs fluvoxamine vs ivermectin vs metformin+fluvoxamine vs metformin+ivermectin is superior to placebo in non-hospitalized adults with SARS-CoV-2 disease for preventing Covid-19 disease progression. 2. To understand if the active treatm...
What is the current status of trial NCT04510194?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,323 participants. The study started on 2021-01-01. Estimated completion is 2022-02-14.
What conditions does trial NCT04510194 study?
This clinical trial studies the following conditions: Covid19, SARS-CoV Infection.
What interventions are being tested in trial NCT04510194?
The interventions under investigation include: Placebo (DRUG), Ivermectin (DRUG), Metformin (DRUG), Fluvoxamine (DRUG).
Who is sponsoring clinical trial NCT04510194?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04510194 being conducted?
This trial has 7 study locations across California, Colorado, Illinois, Indiana, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.