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Anti-diabetic Medication

Metformin for COVID-19

Phase 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 7, 14, 28, 90, 120, and 180
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am 30 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Mean Days Benefit as Measured by the Symptom and Clinical Event Scale
Number of Participants With Hospitalization or Death
Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death
+14 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%
Squamous cell carcinoma of the tongue
1%
Femoral neck fracture
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
23,608 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
322 Previous Clinical Trials
386,763 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
857 Previous Clinical Trials
657,193 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available spots for participants in this experiment?

"Clinicaltrials.gov reveals that this medical trial is quickly seeking participants, having first been announced on September 5th 2023 and most recently updated 19 days later."

Answered by AI

How many places can patients access this trial?

"This trial is currently present at 5 distinct medical institutions, including Northwestern University in Chicago, the University of Minnesota in Minneapolis, and Duke Clinical Research Institute in Durham. There are also an additional five sites hosting this study."

Answered by AI

What is the recruitment size of this research endeavor?

"15000 volunteers that satisfy the specified inclusion criteria are needed to complete this study. The trials can be conducted at two of the many approved facilities, like Northwestern Univesity in Chicago, Illinois and University of Minnesota in Minneapolis, Minnesota."

Answered by AI

Has the Food and Drug Administration given its stamp of approval to Arm G - Metformin?

"We at Power rate the safety of Arm G - Metformin to be a 3 on account of its Phase 3 trial status; providing evidence that it is efficacious and has been affirmed as safe."

Answered by AI

Who else is applying?

What site did they apply to?
Innovation Clinical Trials Inc.
Romancare Health Services
First Care Medical Clinic
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

Loose time and need a little cash.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)
Susanna Naggie, MD 2023. "ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06042855.
All > Paid Studies Las Vegas > Spokane
~1875 spots leftby Jun 2024
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