ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)
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 will receive either study drug or placebo. Participants will self-report any new or worsening symptoms or medical events experienced while taking study drug or placebo. This study is intended to be all remote with no in person visits, unless the study team feels it is in the best interest of a participant to be seen in person. Prior and current drug arms are listed on clinicaltrials.gov and will be updated with the activation of any new drug arms. Each study arm will also have its own clinicaltrials.gov entry and will include "Pro00107921" in the Unique Protocol ID.
Timeline
- Start
- 2023-09-05
- Primary completion
- 2024-06-03
- Completion
- 2024-11-04
Outcome
Missed primary endpoint
registry analysis (superiority test); Arm G - Metformin vs Arm G - Placebo; Hazard Ratio (HR) 0.96 (95% CI 0.89 to 1.03) NCT06042855 ↗
registry analysis (superiority test); Arm G - Metformin vs Arm G - Placebo; Hazard Ratio (HR) 1.43 (95% CI 0.32 to 6.38) NCT06042855 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 500 mg | Oral |
| Subject | Metformin | Small molecule | 1000 mg | Oral |