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

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).

Conditions

• Covid19
• SARS-CoV Infection

Interventions

DRUG

Metformin

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.

DRUG

Placebo

placebo; appearance and size are exact matching to the three study drugs.

DRUG

Fluvoxamine

An antidepressant, administered 50mg per day on Day 1; then 50mg twice-daily for Day 2 through Day 14

DRUG

Ivermectin

An anti-parasitic medication administered as 390mcg/kg to 470mcg/kg per day for 3 days

Sponsors & Collaborators

• UnitedHealth Group

  collaborator INDUSTRY

• Northwestern University

  collaborator OTHER

• Hennepin County Medical Center, Minneapolis

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Olive View-UCLA Education & Research Institute

  collaborator OTHER

• University of Minnesota

  lead OTHER

Principal Investigators

• Carolyn Bramante, MD · University of Minnesota

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

30 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-01

Primary Completion

2022-12-14

Completion

2022-12-14

FDA Drug

Yes

Countries

• United States

Study Locations