ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)
Covid19
![Susanna Naggie, MD](https://trials-media.s3.amazonaws.com/orgs/susanna-naggie-md.jpeg)
About this trial
This is an interventional treatment trial for Covid19 focused on measuring SARS-CoV-2, COVID-19, Placebo, Duke University Health System, Outcomes, Duke Clinical Research Institute, ACTIV 6, ACTIV, metformin
Eligibility Criteria
Eligibility for overall study are listed below. There may be additional appendix-specific criteria. Inclusion Criteria: Completed Informed Consent Age ≥ 30 years old 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 Exclusion Criteria: Current or recent (within 10 days of screening) hospitalization for COVID-19 infection Current or planned participation in another interventional trial to treat COVID-19, at the discretion of the study principal investigator (PI) Current or recent use (within the last 14 days) of study drug or study drug/device combination Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo Known contraindication(s) to study drug including prohibited concomitant medications Previous or current enrollment in the ACTIV-6 trial
Sites / Locations
- Chandler Regional Medical Center
- Lamb Health, LLC
- First Care Medical Clinic
- Trident Health Center
- University of Arkansas Medical Sciences
- Hoag Memorial Hospital Presbyterian
- Assuta Family Medical Group APMC
- Stanford
- Olive View - UCLA Medical Center
- Doctors Medical Group of Colorado Springs, P.C.
- Pine Ridge Family Medicine Inc.
- Tabitha B. Fortt, M.D., LLC
- George Washington University Hospital
- Arena Medical Group
- Lupus Foundation of Gainesville
- University of Florida Health
- L and A Morales Healthcare, Inc
- University of Florida-JAX-ASCENT
- AMRON Vitality and Wellness Center, LLC
- Sunshine Walk In Clinic
- Lakeland Regional Medical Center
- The Angel Medical Research Corporation
- Jackson Memorial Hospital
- University of Miami
- Well Pharma Medical Research
- Innovation Clinical Trials Inc.
- Lice Source Services Plantation
- Premier Health
- Tallahassee Memorial Hospital
- Tampa General Hospital
- UF Health Precision Health ResearchRecruiting
- Morehouse School of Medicine
- Emory Healthcare
- Essential Medical Care, Inc.
- Clincept, LLC
- HOPE Clinical Research and Wellness
- David Kavtaradze MD, Inc.
- Elite Family Practice
- Christ the King Health Care, P.C.
- Miller Family Practice, LLC
- Northwestern Univesity
- Rush University Medical Center
- Olivo Wellness Medical Center
- NorthShore Medical Group
- Advanced Medical Care, Ltd
- Loyola University Medical Center
- Franciscan Health Michigan City
- Del Pilar Medical and Urgent Care
- University of Kansas - Wichita
- A New Start II, LLC
- Christus Saint Frances Hospita
- University Medical Center- New Orleans
- Ochsner Clinic Foundation
- Johns Hopkins Hospital
- Jadestone Clinical Research, LLC
- Boston Medical Center
- Health Quality Primary Care
- University of Massachusetts Medical School
- Ananda Medical Clinic
- GFC of Southeastern Michigan, PC
- Romancare Health Services
- Essentia Health
- University of MinnesotaRecruiting
- University of Missouri - Columbia
- Comprehensive Pain Management and Endocrinology
- Focus Clinical Research Solutions
- Raritan Bay Primary Care & Cardiology Associates
- G&S Medical Associates, LLC
- Mediversity Healthcare
- Christus St. Vincent Regional Medical Center
- Geriatrics and Medical Associates
- Weill Cornell Medical College
- Spinal Pain and Medical Rehab, PC
- Vaidya MD PLLC
- Maria Medical Center, PLLC
- Duke Clinical Research InstituteRecruiting
- Duke University Medical Center
- Lapis Clinical Research
- Superior Clinical Research
- Wake Forest Baptist Health
- Diabetes and Endocrinology Assoc. of Stark County
- University of Cincinnati
- TriHealth, Inc
- The Heart and Medical Center
- Hugo Medical clinic
- Ascension St. John
- Bucks County Clinical Research
- Temple University Hospital
- University of Pittsburgh
- Medical University of South Carolina
- Clinical Trials Center of Middle TN
- Rapha Family Wellness
- Medical Specialists of Knoxville
- Vanderbilt University Medical Center
- Express Family Clinic
- DHR Health Institute for Research
- Texas Tech University Health Sciences Center
- Brooke Army Medical Center
- Texas Health Physicians Group
- Highlands Medical Associates, P.A.
- University of Texas Health Science Center at Houston
- Family Practice Doctors P.A.
- Texas Health Physicians Group
- Kintex Group Texas LLC, DBA Activian Clinical Research
- University Diagnostics and Treatment Clinic
- University of Texas Health Science Center at San Antonio
- Jeremy W. Szeto, D.O., P.A.
- University of Texas Rio Grande Valley
- University of Virginia
- Providence Medical Research Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm G - Metformin
Arm G - Placebo
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.
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.