ACTIV-6: COVID-19 Study of Repurposed Medications - Arm C (Fluticasone)
ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications
2 other identifiers
interventional
1,407
1 country
87
Brief 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. 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. This protocol was originally registered under NCT04885530. Per recent guidance on reporting master protocol research programs (MPRPs), a separate record for Arm C was created.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 covid19
Started Aug 2021
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2022
CompletedFirst Submitted
Initial submission to the registry
February 17, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedResults Posted
Study results publicly available
April 12, 2023
CompletedJune 18, 2023
May 1, 2023
7 months
February 17, 2023
March 17, 2023
May 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Sustained Recovery in Days
Time to sustained recovery was the number of days between receipt of study drug and the third of 3 consecutive days without symptoms. Participants who died, by definition, did not recover regardless of reported symptom freedom. The reported summary is the median survival time.
Up to 28 days
Secondary Outcomes (16)
Number of Participants With Hospitalization or Death
Up to 28 days
Number of Participants With Mortality
Up to 28 days
Time to Mortality
Up to 28 days
Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death
Up to 28 days
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
Day 7
- +11 more secondary outcomes
Study Arms (2)
Arm C - Fluticasone
EXPERIMENTALFluticasone 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.
Arm C - Placebo
PLACEBO COMPARATORPlacebo is a self-administered inhaled agent. 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.
Interventions
Fluticasone furoate is an inhaled powder drug product composed of fluticasone furoate. It is a synthetic trifluorinated corticosteroid that is insoluble in water. Fluticasone furoate is a white powder and will be provided in a two tone grey inhaler with a mouthpiece cover and separate foil blister strips. The inhaler will be packaged in a moisture-protective foil tray with a desiccant and a peelable lid.All packaging will be labeled to indicate that the product is for investigational use. Participants will self-administer 200 µg (1 blister) of fluticasone furoate once daily for 14 days.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Prior diagnosis of COVID-19 infection (\> 10 days from screening)
- Current or recent (within 10 days of screening) hospitalization
- Current use 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\*
- \[\*If only one study drug appendix is open at the time of enrollment. If multiple study drug appendices are open, a participant may opt-out of any study drug appendix or be excluded from any study drug appendix based on contraindications listed in the study drug appendix, current use of study drug, or known allergy/sensitivity/hypersensitivity and still remain eligible for the remaining study drug appendices.\]
- Severe hypersensitivity to milk proteins
- Currently prescribed or use within 30 days of inhaled or systemic steroids
- Moderate to severe hepatic impairment, defined as Child-Pugh B or C
- Nursing mothers
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (87)
Lamb Health, LLC
Gilbert, Arizona, 85298, United States
First Care Medical Clinic
Mesa, Arizona, 85203, United States
Trident Health Center
Peoria, Arizona, 85382, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
Assuta Family Medical Group APMC
North Hollywood, California, 91606, United States
Stanford
Palo Alto, California, 94304, United States
Doctors Medical Group of Colorado Springs, P.C.
Colorado Springs, Colorado, 80917, United States
Pine Ridge Family Medicine Inc.
Colorado Springs, Colorado, 80924, United States
Tabitha B. Fortt, M.D., LLC
Stamford, Connecticut, 06905, United States
George Washington University Hospital
Washington D.C., District of Columbia, 20037, United States
Lupus Foundation of Gainesville
Gainesville, Florida, 32606, United States
University of Florida Health
Gainesville, Florida, 32611, United States
University of Florida-JAX-ASCENT
Jacksonville, Florida, 32209, United States
AMRON Vitality and Wellness Center, LLC
Jacksonville, Florida, 32244, United States
Sunshine Walk In Clinic
Lake Mary, Florida, 32746, United States
Lakeland Regional Medical Center
Lakeland, Florida, 33805, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
University of Miami
Miami, Florida, 33136, United States
Well Pharma Medical Research
Miami, Florida, 33173, United States
Innovation Clinical Trials Inc.
Palmetto Bay, Florida, 33157, United States
Lice Source Services Plantation
Plantation, Florida, 33313, United States
Premier Health
St. Petersburg, Florida, 33707, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
UF Health Precision Health Research
The Villages, Florida, 32159, United States
Emory Healthcare
Atlanta, Georgia, 30322, United States
Essential Medical Care, Inc.
College Park, Georgia, 30349, United States
David Kavtaradze MD, Inc.
Cordele, Georgia, 31015, United States
Elite Family Practice
Douglasville, Georgia, 30134, United States
Christ the King Health Care, P.C.
Loganville, Georgia, 30052, United States
Miller Family Practice, LLC
Macon, Georgia, 31201, United States
Olivo Wellness Medical Center
Chicago, Illinois, 60618, United States
NorthShore Medical Group
Evanston, Illinois, 60201, United States
Advanced Medical Care, Ltd
Lake Zurich, Illinois, 60047, United States
Franciscan Health Michigan City
Michigan City, Indiana, 46360, United States
Del Pilar Medical and Urgent Care
Mishawaka, Indiana, 46545, United States
University of Kansas - Wichita
Wichita, Kansas, 67214, United States
A New Start II, LLC
Central City, Kentucky, 42330, United States
University Medical Center- New Orleans
New Orleans, Louisiana, 70112, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287-1900, United States
Jadestone Clinical Research, LLC
Rockville, Maryland, 20855, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Health Quality Primary Care
Lawrence, Massachusetts, 01843, United States
Ananda Medical Clinic
Dearborn, Michigan, 48124, United States
GFC of Southeastern Michigan, PC
Detroit, Michigan, 48202, United States
Romancare Health Services
Detroit, Michigan, 48206, United States
Essentia Health
Duluth, Minnesota, 55805, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
University of Missouri - Columbia
Columbia, Missouri, 65212, United States
Comprehensive Pain Management and Endocrinology
Henderson, Nevada, 89052, United States
Focus Clinical Research Solutions
Bayonne, New Jersey, 07002, United States
Raritan Bay Primary Care & Cardiology Associates
Matawan, New Jersey, 07747, United States
Mediversity Healthcare
Turnersville, New Jersey, 08012, United States
Geriatrics and Medical Associates
Clinton, New York, 13323, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Spinal Pain and Medical Rehab, PC
Yonkers, New York, 10701, United States
Vaidya MD PLLC
Clayton, North Carolina, 27520, United States
Maria Medical Center, PLLC
Dunn, North Carolina, 28334, United States
Duke Clinical Research Institute
Durham, North Carolina, 27701, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27151, United States
Diabetes and Endocrinology Assoc. of Stark County
Canton, Ohio, 44718, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
TriHealth, Inc
Montgomery, Ohio, 45242, United States
The Heart and Medical Center
Durant, Oklahoma, 74701, United States
Hugo Medical clinic
Hugo, Oklahoma, 74743, United States
Bucks County Clinical Research
Morrisville, Pennsylvania, 19067, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29403, United States
Clinical Trials Center of Middle TN
Franklin, Tennessee, 37067, United States
Rapha Family Wellness
Hendersonville, Tennessee, 37075, United States
Medical Specialists of Knoxville
Knoxville, Tennessee, 37938, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
Express Family Clinic
Allen, Texas, 75013, United States
Texas Tech University Health Sciences Center
El Paso, Texas, 79905, United States
Texas Health Physicians Group
Fort Worth, Texas, 76107, United States
Highlands Medical Associates, P.A.
Highlands, Texas, 77562, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Family Practice Doctors P.A.
Humble, Texas, 77338, United States
Vytalus Medical Group
Humble, Texas, 77338, United States
Texas Health Physicians Group
Irving, Texas, 75039, United States
University Diagnostics and Treatment Clinic
Pasadena, Texas, 77504, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Jeremy W. Szeto, D.O., P.A.
Sugar Land, Texas, 77479, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Susanna Naggie, MD, MHS, FIDSA
- Organization
- Duke University
Study Officials
- PRINCIPAL INVESTIGATOR
Susanna Naggie, MD
Duke Clinical Research Institute
- PRINCIPAL INVESTIGATOR
Adrian Hernandez, MD
Duke Clinical Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- The participant and study teams will know which study drug the participant is allocated to, but will be blinded to study drug versus placebo because they will be matching.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
February 17, 2023
First Posted
February 21, 2023
Study Start
August 6, 2021
Primary Completion
March 17, 2022
Study Completion
May 18, 2022
Last Updated
June 18, 2023
Results First Posted
April 12, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, CSR
- Time Frame
- Up to 36 months after publication
- Access Criteria
- Interested investigators will need to seek prior IRB approval before access to any data is granted.
We will share this data after it has been de-identified. We will share data beginning around 6 months after publication and for up to 36 months afterward. Access will only be shared with those who have obtained prior IRB approval to be able to access this data.