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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
Timeline
Screening 7 days
Treatment Varies
Follow Up 120 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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I've had symptoms like fever, cough, or body aches for less than a week.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
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

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
Metformin
2006
Completed Phase 4
~2430
Ivermectin
2020
Completed Phase 4
~7180
Fluvoxamine
2020
Completed Phase 4
~3259230
Fluticasone
2008
Completed Phase 4
~2370
Montelukast
2008
Completed Phase 4
~15460

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

National Center for Advancing Translational Science (NCATS)NIH
99 Previous Clinical Trials
21,374 Total Patients Enrolled
Susanna Naggie, MDLead Sponsor
7 Previous Clinical Trials
23,608 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
316 Previous Clinical Trials
375,653 Total Patients Enrolled

Media Library

Fluticasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04885530 — Phase 3
Coronavirus Research Study Groups: Arm G - Metformin, Arm G - Placebo, Arm A - Placebo, Arm B - Fluvoxamine, Arm C - Fluticasone, Arm D - Placebo, Arm F - Montelukast, Arm F - Placebo, Arm D - Ivermectin 600, Arm B- Placebo, Arm C - Placebo, Arm E - Placebo, Arm A - Ivermectin 400, Arm E - Fluvoxamine 100
Coronavirus Clinical Trial 2023: Fluticasone Highlights & Side Effects. Trial Name: NCT04885530 — Phase 3
Fluticasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04885530 — Phase 3
Coronavirus Patient Testimony for trial: Trial Name: NCT04885530 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does Fluvoxamine commonly help with?

"Fluvoxamine is often given to patients suffering from strongyloidiasis, which is caused by strongyloides stercoralis infection. In addition, Fluvoxamine can help treat other conditions such as obsessive-compulsive disorder, sinusitis, and seasonal allergic rhinitis."

Answered by AI

Where are the patients being drawn from for this trial?

"There are 94 clinical trial sites participating in this study, including but not limited to: Highlands Medical Associates, P.A. in Highlands, Texas, Health Quality Primary Care in Lawrence, Massachusetts, and Olivo Wellness Medical Center in Chicago, Illinois."

Answered by AI

Does fluvoxamine have a history of being studied?

"Fluvoxamine was first studied in 2016 at Milton Keynes University Hospital. So far, there have been 18474 completed studies. 29 trials are still recruiting, many of which are based in Highlands, Texas."

Answered by AI

Does Fluvoxamine have a high potential for abuse?

"Fluvoxamine's safety is well-documented, as it has gone through Phase 3 clinical trials. These trials not only test for efficacy, but also repeat testing to confirm safety."

Answered by AI

Are we currently able to enroll in this trial?

"That is correct, the online information from clinicaltrials.gov does show that the trial is still looking for participants. The 15000 patients needed for the study are being recruited from 94 different locations, and the trial was first posted on June 8th, 2021."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
North Carolina
Other
Texas
How old are they?
18 - 65
What site did they apply to?
Innovation Clinical Trials Inc.
Texas Health Physicians Group
Essential Medical Care, Inc.
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
0

Why did patients apply to this trial?

To try out new medication. I enjoy being part of trials to help find a cure.
PatientReceived 2+ prior treatments
I would like to be a part of finding a cure for diabetes. I would like help find a cure and to help advance treatment for everyone,just a way of doing my part, and get paid.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Lapis Clinical Research: < 24 hours
Average response time
  • < 1 Day
~4000 spots leftby Mar 2025