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Anti-diabetic Medication

Metformin for COVID-19

Phase 3
Waitlist Available
Led By Adrian Hernandez, MD
Research Sponsored by Susanna Naggie, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 30 years old
Be older than 18 years old
Must not have
Known contraindication(s) to study drug including prohibited concomitant medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 7, 14, 28, 90, 120, and 180
Awards & highlights

Summary

This trial is testing if repurposed drugs can reduce symptoms of mild-moderate COVID-19, with participants taking either the drug or a placebo. All visits will be remote, with clinicaltrials.gov listing each drug arm.

Who is the study for?
This trial is for adults over 30 with mild to moderate COVID-19, not hospitalized, experiencing symptoms like fatigue and fever for up to 7 days. They must have a confirmed SARS-CoV-2 infection. People can't join if they've been in the hospital for COVID-19 recently, are allergic to study drugs, or are using those drugs already.
What is being tested?
The ACTIV-6 trial is testing Metformin against a placebo in non-hospitalized patients with COVID-19. It aims to see if Metformin can reduce symptoms when taken at home. The study involves no in-person visits unless necessary and relies on participants reporting their symptoms remotely.
What are the potential side effects?
While specific side effects of Metformin in this trial context aren't listed, common ones include digestive issues like nausea and diarrhea, potential vitamin B12 deficiency over time, and rarely a serious condition called lactic acidosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 30 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not allergic or sensitive to the study drug or any related medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 7, 14, 28, 90, 120, and 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7, 14, 28, 90, 120, and 180 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Mean Days Benefit as Measured by the Symptom and Clinical Event Scale
Number of Participants With Hospitalization or Death
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14.
+12 more

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm G - MetforminExperimental Treatment1 Intervention
Metformin IR tablets will be self-administered orally according to the following dosing schedule: * 500 mg on Day 1; * 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and * 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
Group II: Arm G - PlaceboPlacebo Group1 Intervention
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

Susanna Naggie, MDLead Sponsor
7 Previous Clinical Trials
23,658 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
342 Previous Clinical Trials
395,468 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
888 Previous Clinical Trials
919,934 Total Patients Enrolled
~7500 spots leftby Sep 2025
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