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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
Confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening
Two or more current symptoms of acute infection for ≤7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upday 7, 14, 28, 90, 120, and 180
Awards & highlights
Pivotal Trial

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.

Eligible Conditions
  • Coronavirus

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have had a verified coronavirus infection as determined by an accepted PCR or antigen test taken within the past 10 days.
Select...
You have experienced two or more symptoms of acute infection for a maximum duration of seven days, including but not limited to fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
23,588 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
292 Previous Clinical Trials
372,495 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
831 Previous Clinical Trials
642,709 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, 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?
University of Texas Health Science Center at Houston
What portion of applicants met pre-screening criteria?
Did not meet criteria
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 > Pflugerville Tx > Paid Studies Pasadena
~9000 spots leftby Mar 2024
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