NCT06042855

ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

ACTIVE_NOT_RECRUITING

NCT ID:

NCT06042855

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

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.

Eligibility

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

Disease(s) and\or Condition(s)

Covid19

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: OTHER
- Name: Placebo
- Description: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
- Arm Group Labels: Arm G - Placebo
- Type: DRUG
- Name: Metformin
- Description: Metformin IR tablets contain the active metformin hydrochloride and inactive ingredients including povidone and magnesium stearate. Commercially available metformin 500 mg tablets will be provided.
- Arm Group Labels: Arm G - Metformin

Sponsor

Susanna Naggie, MD