CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,214 enrolled
Drug / intervention
Metformin +1 moredrug
Likely dose
Metformin 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06042855
NCT06042855Phase 3Completed

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

Susanna Naggie, MD·interventional·Posted Sep 21, 2023·Updated Nov 18, 2025

In Brief

A Phase 3 clinical trial evaluating Placebo and Metformin for Covid19. Completed, enrolled 3,214 participants across 110 sites.

Detailed Summary

The purpose of this study is to evaluate the effectiveness of repurposed medications (study drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19. Participants will receive either study drug or placebo. Participants will self-report any new or worsening symptoms or medical events experienced while taking study drug or placebo. This study is intended to be all remote with no in person visits, unless the study team feels it is in the best interest of a participant to be seen in person. Prior and current drug arms are listed on clinicaltrials.gov and will be updated with the activation of any new drug arms. Each study arm will also have its own clinicaltrials.gov entry and will include "Pro00107921" in the Unique Protocol ID.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesUnited States

Timeline

Phase 3CompletedFinished
202420252026
First PostedSep 21, 2023
Enrollment StartSep 5, 2023
Primary CompletionJun 3, 2024
Study CompletionNov 4, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 2.8 years ago

Interventions

Placeboother

Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.

Metformindrug

Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.