Status:
COMPLETED
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)
Lead Sponsor:
Susanna Naggie, MD
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Vanderbilt University Medical Center
Conditions:
Covid19
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief 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 w...
Detailed Description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus that first emerged in December 2019 and has since caused a global pandemic unseen in almost a century with respe...
Eligibility Criteria
Inclusion
- Eligibility for overall study are listed below. There may be additional appendix-specific 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
- 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
Key Trial Info
Start Date :
September 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2024
Estimated Enrollment :
3214 Patients enrolled
Trial Details
Trial ID
NCT06042855
Start Date
September 5 2023
End Date
November 4 2024
Last Update
November 18 2025
Active Locations (110)
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1
Chandler Regional Medical Center
Chandler, Arizona, United States, 85224
2
Lamb Health, LLC
Gilbert, Arizona, United States, 85298
3
First Care Medical Clinic
Mesa, Arizona, United States, 85203
4
Trident Health Center
Peoria, Arizona, United States, 85382