Repurposed Medications for COVID-19

Recruiting at111 trial locations

Overseen by Susanna Naggie, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Susanna Naggie, MD

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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. They will self-report any new or worsening symptoms or medical events they may experience 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 see them 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. Pro00107921_A - Arm D (Ivermectin 400) - NCT05736861; Pro00107921_B - Arm B (Fluvoxamine) - NCT05890586; Pro00107921_C - Arm C (Fluticasone) - NCT05736874; Pro00107921_D - Arm D (Ivermectin 600) - NCT05894538; Pro00107921_E - Arm E (Fluvoxamine 100) - NCT05894564; Pro00107921_F - Arm F (Montelukast) - NCT05894577; Pro00107921_G - Arm G (Metformin) - NCT06042855.

Research Team

Adrian Hernandez, MD

Principal Investigator

Duke Clinical Research Institute

Susanna Naggie, MD

Principal Investigator

Duke Clinical Research Institute

Eligibility Criteria

This trial is for non-hospitalized individuals over 30 years old with mild to moderate COVID-19, confirmed by a test within the last 10 days. They must have had symptoms like fatigue or fever for no more than a week and be able to give informed consent. People who've been hospitalized recently or have allergies to the study drugs can't participate.

Inclusion Criteria

I am 30 years old or older.

Confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening

I am 30 years old or older.

Exclusion Criteria

Confirmed positive COVID-19 test within the last 10 days

I have been in the hospital recently or am currently hospitalized.

Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo

Treatment Details

Interventions

• Fluticasone (Corticosteroid)
• Fluvoxamine (Antidepressant)
• Ivermectin (Anti-parasitic)
• Montelukast (Anti-inflammatory)
• Placebo (Other)

Trial Overview The ACTIV-6 trial is testing if repurposed medications such as Metformin, Ivermectin, Fluvoxamine, Fluticasone, and Montelukast can reduce COVID-19 symptoms compared to a placebo. Participants will report their symptoms remotely unless an in-person visit is necessary.

Participant Groups

Group I: Arm G - Metformin Experimental Treatment 1 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 F - Montelukast Experimental Treatment 1 Intervention

Montelukast will be self-administered orally by each participant at a dose of 10 mg once a day for 14 days.

Group III: Arm E - Fluvoxamine 100 Experimental Treatment 1 Intervention

Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day for 12 days.

Group IV: Arm D - Ivermectin 600 Experimental Treatment 1 Intervention

Ivermectin - 7-mg tablets Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 µg/kg.

Group V: Arm C - Fluticasone Experimental Treatment 1 Intervention

Fluticasone is a self-administered inhaled drug. Participants will self-administer 200 µg (1 blister) of fluticasone once daily for 14 days. After inhaler activation, the powder within the blister is exposed and the participant inhales the study drug through the mouthpiece.

Group VI: Arm B - Fluvoxamine Experimental Treatment 1 Intervention

Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.

Group VII: Arm A - Ivermectin 400 Experimental Treatment 1 Intervention

Ivermectin - 7-mg tablets Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.

Group VIII: Arm G - Placebo Placebo Group 1 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.

Group IX: Arm A - Placebo Placebo Group 1 Intervention

Placebo - appearance and size matched to active study drug. Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.

Group X: Arm D - Placebo Placebo Group 1 Intervention

Placebo - appearance and size matched to active study drug. Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight, matched to active study drug dosing.

Group XI: Arm F - Placebo Placebo Group 1 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.

Group XII: Arm B- Placebo Placebo Group 1 Intervention

Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.

Group XIII: Arm C - Placebo Placebo Group 1 Intervention

Placebo is a self-administered by inhalation. Participants will self-administer 1 blister of placebo once daily for 14 days. After inhaler activation, the powder within the blister is exposed and the participant inhales the placebo through the mouthpiece.

Group XIV: Arm E - Placebo Placebo Group 1 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.

Fluticasone is already approved in Canada for the following indications:

Approved in Canada as Fluticasone for:

• Allergic rhinitis
• Asthma
• COPD

Who Is Running the Clinical Trial?

Susanna Naggie, MD

Lead Sponsor

Trials

8

Recruited

22,800+

National Center for Advancing Translational Science (NCATS)

Collaborator

Trials

100

Recruited

32,100+

Joni L. Rutter

National Center for Advancing Translational Science (NCATS)

Chief Executive Officer since 2022

PhD in Pharmacology

Dominique C. Pichard

National Center for Advancing Translational Science (NCATS)

Chief Medical Officer since 2023

MD

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Dominique C. Pichard

National Center for Advancing Translational Sciences (NCATS)

Chief Medical Officer since 2023

MD

Joni L. Rutter

National Center for Advancing Translational Sciences (NCATS)

Chief Executive Officer since 2022

PhD in Pharmacology

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Jeffrey R. Balser

Vanderbilt University Medical Center

Chief Executive Officer since 2009

MD and PhD from Vanderbilt University

Rick W. Wright

Vanderbilt University Medical Center

Chief Medical Officer since 2023

MD from University of Missouri-Columbia