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Corticosteroid

Repurposed Medications for COVID-19

Phase 3

Waitlist Available

Led By Adrian Hernandez, MD

Research Sponsored by Susanna Naggie, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 30 years old

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

Must not have

Known contraindication(s) to study drug including prohibited concomitant medications

Timeline

Screening 7 days

Treatment Varies

Follow Up 120 days

Awards & highlights

Pivotal Trial

Summary

This trial is testing whether repurposed drugs can help relieve symptoms in people with mild to moderate COVID-19. People will either get the drugs or a placebo, and report any new or worsening symptoms. The trial is mostly remote, but some people may need in-person visits.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of the medications may include digestive issues (like nausea), headaches, dizziness, potential allergic reactions, and other drug-specific effects which vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 30 years old or older.

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I have had symptoms like fever, cough, or body aches for less than a week.

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I am 30 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not allergic or unable to take the study drug due to other medications I'm on.

Timeline

Screening ~ 7 days1 visit

Treatment ~ Varies

Follow Up ~ 120 days0 visits

Screening ~ 7 days

Treatment ~ Varies

Follow Up ~120 days

This trial's timeline: 7 days for screening, Varies for treatment, and 120 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Mean Days Benefit as Measured by the Symptom and Clinical Event Scale

Number of Participants With Hospitalization or Death

Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death

+14 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

14Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm G - MetforminExperimental Treatment1 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 - MontelukastExperimental Treatment1 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 100Experimental Treatment1 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 600Experimental Treatment1 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 - FluticasoneExperimental Treatment1 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 - FluvoxamineExperimental Treatment1 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 400Experimental Treatment1 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 - PlaceboPlacebo Group1 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 - PlaceboPlacebo Group1 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 - PlaceboPlacebo Group1 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 - PlaceboPlacebo Group1 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- PlaceboPlacebo Group1 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 - PlaceboPlacebo Group1 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 - PlaceboPlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ivermectin

2016

Completed Phase 4

~36480

Fluvoxamine

2020

Completed Phase 4

~3259220