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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 COVID-19 and SARS-CoV Infection, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,323
- Enrollment target
- 7
- Study locations
NCT04510194: Completed Phase 3 study of COVID-19 and SARS-CoV Infection, sponsored by University of Minnesota.
NCT04510194 is a Phase 3 study of COVID-19 and SARS-CoV Infection that has completed, run by University of Minnesota. The registered enrollment target is 1,323 participants, below the 38,461-participant average among 298 other COVID-19 trials with a reported enrollment target (97% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04510194, a Phase 3 study of COVID-19 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).
Primary Outcome
Clinical progression, defined as Emergency department visit for any COVID-19 related symptom (including hospitalization or death) or decrease in O2 saturation (\<=93% on room air, or need for supplemental oxygen to maintain an O2 saturation \<=93%)
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 |
What the finished NCT04510194 record still lists
NCT04510194 is an interventional study that assigns participants to a tested intervention. Its 1,323 participants enrollment target places it among the larger protocols in the corpus, below the 38,461-participant average among 298 other COVID-19 trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with COVID-19 appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT04510194 lists 7 locations in 5 states (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: COVID-19, 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.
Learn More About Clinical Trials
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Where NCT04510194's enrollment target sits among peer trials
1,323 59th of 298 higher than 240 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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