Covid19Phase 3NCT05736874
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm C (Fluticasone)
A Phase 3 study testing Fluticasone in people with Covid19, run by Susanna Naggie, MD at 87 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Fluticasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,407 participants
- Where
- 87 sitesUnited States
- Study dates
- 6 Aug 2021to 18 May 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.]
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- Arm-specific exclusion criteria
- 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
Trial locations and contacts
87 sites in 1 country.
87 sites in 1 country
United States87 sites
Express Family Clinic
Allen, Texas, 75013
Emory Healthcare
Atlanta, Georgia, 30322
Johns Hopkins Hospital
Baltimore, Maryland, 21287-1900
Focus Clinical Research Solutions
Bayonne, New Jersey, 07002
Boston Medical Center
Boston, Massachusetts, 02118
Diabetes and Endocrinology Assoc. of Stark County
Canton, Ohio, 44718
A New Start II, LLC
Central City, Kentucky, 42330
Medical University of South Carolina
Charleston, South Carolina, 29403
University of Virginia
Charlottesville, Virginia, 22903
Olivo Wellness Medical Center
Chicago, Illinois, 60618
University of Cincinnati
Cincinnati, Ohio, 45267
Vaidya MD PLLC
Clayton, North Carolina, 27520
Geriatrics and Medical Associates
Clinton, New York, 13323
Essential Medical Care, Inc.
College Park, Georgia, 30349
Doctors Medical Group of Colorado Springs, P.C.
Colorado Springs, Colorado, 80917
Pine Ridge Family Medicine Inc.
Colorado Springs, Colorado, 80924
University of Missouri - Columbia
Columbia, Missouri, 65212
David Kavtaradze MD, Inc.
Cordele, Georgia, 31015
Ananda Medical Clinic
Dearborn, Michigan, 48124
GFC of Southeastern Michigan, PC
Detroit, Michigan, 48202
Romancare Health Services
Detroit, Michigan, 48206
Elite Family Practice
Douglasville, Georgia, 30134
Essentia Health
Duluth, Minnesota, 55805
Maria Medical Center, PLLC
Dunn, North Carolina, 28334
The Heart and Medical Center
Durant, Oklahoma, 74701
Duke Clinical Research Institute
Durham, North Carolina, 27701
Duke University Medical Center
Durham, North Carolina, 27710
Texas Tech University Health Sciences Center
El Paso, Texas, 79905
NorthShore Medical Group
Evanston, Illinois, 60201
Texas Health Physicians Group
Fort Worth, Texas, 76107
Clinical Trials Center of Middle TN
Franklin, Tennessee, 37067
Lupus Foundation of Gainesville
Gainesville, Florida, 32606
University of Florida Health
Gainesville, Florida, 32611
Lamb Health, LLC
Gilbert, Arizona, 85298
Comprehensive Pain Management and Endocrinology
Henderson, Nevada, 89052
Rapha Family Wellness
Hendersonville, Tennessee, 37075
Highlands Medical Associates, P.A.
Highlands, Texas, 77562
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Hugo Medical clinic
Hugo, Oklahoma, 74743
Family Practice Doctors P.A.
Humble, Texas, 77338
Vytalus Medical Group
Humble, Texas, 77338
Texas Health Physicians Group
Irving, Texas, 75039
University of Florida-JAX-ASCENT
Jacksonville, Florida, 32209
AMRON Vitality and Wellness Center, LLC
Jacksonville, Florida, 32244
Medical Specialists of Knoxville
Knoxville, Tennessee, 37938
Sunshine Walk In Clinic
Lake Mary, Florida, 32746
Advanced Medical Care, Ltd
Lake Zurich, Illinois, 60047
Lakeland Regional Medical Center
Lakeland, Florida, 33805
Health Quality Primary Care
Lawrence, Massachusetts, 01843
Christ the King Health Care, P.C.
Loganville, Georgia, 30052
Miller Family Practice, LLC
Macon, Georgia, 31201
Raritan Bay Primary Care & Cardiology Associates
Matawan, New Jersey, 07747
First Care Medical Clinic
Mesa, Arizona, 85203
Jackson Memorial Hospital
Miami, Florida, 33136
University of Miami
Miami, Florida, 33136
Well Pharma Medical Research
Miami, Florida, 33173
Franciscan Health Michigan City
Michigan City, Indiana, 46360
University of Minnesota
Minneapolis, Minnesota, 55455
Del Pilar Medical and Urgent Care
Mishawaka, Indiana, 46545
TriHealth, Inc
Montgomery, Ohio, 45242
Bucks County Clinical Research
Morrisville, Pennsylvania, 19067
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
University Medical Center- New Orleans
New Orleans, Louisiana, 70112
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Weill Cornell Medical College
New York, New York, 10065
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Assuta Family Medical Group APMC
North Hollywood, California, 91606
Innovation Clinical Trials Inc.
Palmetto Bay, Florida, 33157
Stanford
Palo Alto, California, 94304
University Diagnostics and Treatment Clinic
Pasadena, Texas, 77504
Trident Health Center
Peoria, Arizona, 85382
Temple University Hospital
Philadelphia, Pennsylvania, 19140
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Lice Source Services Plantation
Plantation, Florida, 33313
Jadestone Clinical Research, LLC
Rockville, Maryland, 20855
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Premier Health
St. Petersburg, Florida, 33707
Tabitha B. Fortt, M.D., LLC
Stamford, Connecticut, 06905
Jeremy W. Szeto, D.O., P.A.
Sugar Land, Texas, 77479
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
Tampa General Hospital
Tampa, Florida, 33606
UF Health Precision Health Research
The Villages, Florida, 32159
Mediversity Healthcare
Turnersville, New Jersey, 08012
George Washington University Hospital
Washington D.C., District of Columbia, 20037
University of Kansas - Wichita
Wichita, Kansas, 67214
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27151
Spinal Pain and Medical Rehab, PC
Yonkers, New York, 10701
About this study
Official title: ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications
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.
Read the detailed description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus that first emerged in December 2019 and has since caused a global pandemic unseen in almost a century with respect to the number of cases and overall mortality. The clinical disease related to SARS-CoV-2 is referred to as Coronavirus Disease 2019 (COVID-19). Over 2020, advances were made for treatment of COVID-19 and several vaccinations have received emergency use authorization for prevention of SARS-CoV-2 infections. However, the pandemic continues to evolve with new variants and surges of infections in different regions of the world, requiring an ongoing evidence-generating platform, in particular for the treatment of COVID-19 infection in the outpatient setting.
This proposed platform protocol can serve as an evidence generating system for prioritized drugs repurposed from other indications with an established safety record and preliminary evidence of clinical efficacy for the treatment of COVID-19. The ultimate goal is to evaluate if repurposed medications can make participants feel better faster and reduce death and hospitalization.
This platform protocol is designed to be flexible so that it is suitable for a wide range of settings within healthcare systems and in community settings where it can be integrated into routine COVID-19 testing programs and subsequent treatment plans. This platform protocol will enroll participants in an outpatient setting with a confirmed polymerase chain reaction (PCR) or antigen test for SARS-CoV-2.
Participants will be randomized to study drugs or placebo based on the arms that are actively enrolling at the time of randomization. Study drugs may be added or removed according to adaptive design and/or emerging evidence. When there are multiple study drugs available, randomization will occur based on appropriateness of each drug for the participant as determined by the study protocol and investigator and participant equipoise. Each participant will be required to randomize to at least one study drug versus placebo.
Eligible participants will be randomized in a blinded fashion, to either the study drug arm or placebo arm in addition to standard of care. Participants will receive a complete supply study drug or placebo with the quantity depending on the study drug/placebo to which they are randomized. The randomization will be altered to leverage placebo data across arms, and data will be analyzed by shared placebo.
All study visits are designed to be remote. However, screening and enrollment may occur in-person at sites and unplanned study visits may occur in-person or remotely, as deemed appropriate by the site investigator for safety purposes. Participants will be asked to complete questionnaires and report safety events during the study. Participants will be prompted by the online system to report safety events and these will be reviewed and confirmed via medical records and site staff, as necessary.
- Conditions
- Covid19
- Being tested
- Fluticasone, Placebo
- Keywords
- SARS-CoV-2, COVID-19, Placebo, Duke University Health System, Outcomes, Duke Clinical Research Institute, fluticasone, ACTIV 6, ACTIV
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluticasoneDrug
Also called Fluticasone Furoate
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm C - Fluticasone | Experimental | 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. Receives: Drug: Fluticasone |
| Arm C - Placebo | Placebo comparator | Placebo 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 28 days
Secondary outcomes (16)
Number of Participants With Hospitalization or Death
Measured: Up to 28 days
Number of Participants With Mortality
Measured: Up to 28 days
Time to Mortality
Time to mortality was the number of days between drug receipt and death.
Measured: Up to 28 days
Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death
Measured: Up to 28 days
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
Measured: Day 7
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
Measured: Day 14
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
Measured: Day 28
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a higher score correlates to better outcome for physical function.
Measured: Day 7, 14, 28, and 90
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for fatigue.
Measured: Day 7, 14, 28, and 90
Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for pain.
Measured: Day 7, 14, 28, and 90
Quality of Life (QOL) as Measured by the PROMIS-29 - Depression
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for depression.
Measured: Day 7, 14, 28, and 90
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for anxiety.
Measured: Day 7, 14, 28, and 90
Quality of Life (QOL) as Measured by the PROMIS-29 - Social
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a higher score correlates to better outcome for social roles and activities.
Measured: Day 7, 14, 28, and 90
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for sleep.
Measured: Day 7, 14, 28, and 90
Time Unwell in Days as Measured by the Symptom and Clinical Event Scale
The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). Time unwell was the portion of follow-up (in days) that a participant was symptomatic, hospitalized, or deceased. The quantity is estimated from a Bayesian longitudinal ordinal regression model with covariate adjustment and weakly informative priors.
Measured: Up to 14 days
Mean Days Benefit as Measured by the Symptom and Clinical Event Scale
The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). The cumulative benefit of treatment A is the probability of experiencing a better outcome on treatment A compared to treatment B, summed over the days of follow-up. The difference between the cumulative benefit of treatment A and the cumulative benefit of treatment B is known as the difference in days benefit. Measure of dispersion is 95% credible interval.
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start6 Aug 2021
- Primary completion17 Mar 2022
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-Blind, Placebo-Controlled, Randomized Trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susanna Naggie, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), Vanderbilt University Medical Center
- Responsible party
- Sponsor-investigator, Susanna Naggie, MD, Duke University
- Investigators
- Susanna Naggie, MD, Principal investigator, Duke Clinical Research InstituteAdrian Hernandez, MD, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736874
- Sponsor's protocol ID
- Pro00107921_C
- Other IDs
- 3U24TR001608-05W1
- Status last verified
- May 2023
- First submitted
- 17 Feb 2023
- Last updated
- 18 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications
- ClinicalTrials.gov ID
- NCT05736874
- Acronym / sponsor ID
- Pro00107921_C
- Conditions
- Covid19
- Keywords
- SARS-CoV-2, COVID-19, Placebo, Duke University Health System, Outcomes, Duke Clinical Research Institute, fluticasone, ACTIV 6
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,407 participants (actual)
- Lead sponsor
- Susanna Naggie, MDUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), Vanderbilt University Medical Center
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Posted 12 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus that first emerged in December 2019 and has since caused a global pandemic unseen in almost a century with respect to the number of cases and overall mortality. The clinical disease related to SARS-CoV-2 is referred to as Coronavirus Disease 2019 (COVID-19). Over 2020, advances were made for treatment of COVID-19 and several vaccinations have received emergency use authorization for prevention of SARS-CoV-2 infections. However, the pandemic continues to evolve with new variants and surges of infections in different regions of the world, requiring an ongoing evidence-generating platform, in particular for the treatment of COVID-19 infection in the outpatient setting.
This proposed platform protocol can serve as an evidence generating system for prioritized drugs repurposed from other indications with an established safety record and preliminary evidence of clinical efficacy for the treatment of COVID-19. The ultimate goal is to evaluate if repurposed medications can make participants feel better faster and reduce death and hospitalization.
This platform protocol is designed to be flexible so that it is suitable for a wide range of settings within healthcare systems and in community settings where it can be integrated into routine COVID-19 testing programs and subsequent treatment plans. This platform protocol will enroll participants in an outpatient setting with a confirmed polymerase chain reaction (PCR) or antigen test for SARS-CoV-2.
Participants will be randomized to study drugs or placebo based on the arms that are actively enrolling at the time of randomization. Study drugs may be added or removed according to adaptive design and/or emerging evidence. When there are multiple study drugs available, randomization will occur based on appropriateness of each drug for the participant as determined by the study protocol and investigator and participant equipoise. Each participant will be required to randomize to at least one study drug versus placebo.
Eligible participants will be randomized in a blinded fashion, to either the study drug arm or placebo arm in addition to standard of care. Participants will receive a complete supply study drug or placebo with the quantity depending on the study drug/placebo to which they are randomized. The randomization will be altered to leverage placebo data across arms, and data will be analyzed by shared placebo.
All study visits are designed to be remote. However, screening and enrollment may occur in-person at sites and unplanned study visits may occur in-person or remotely, as deemed appropriate by the site investigator for safety purposes. Participants will be asked to complete questionnaires and report safety events during the study. Participants will be prompted by the online system to report safety events and these will be reviewed and confirmed via medical records and site staff, as necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Double-Blind, Placebo-Controlled, Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Arm C - Fluticasone | Experimental | Drug: FluticasoneFluticasone 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 comparator | Other: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluticasoneAlso: Fluticasone FuroateFluticasone 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. | Drug | Arm C - Fluticasone |
| PlaceboEach 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. | Other | Arm C - Placebo |
Primary outcome
Time to Sustained Recovery in Days
Time frame: Up to 28 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.
16 secondary outcomes
Number of Participants With Hospitalization or Death
Time frame: Up to 28 days
Number of Participants With Mortality
Time frame: Up to 28 days
Time to Mortality
Time frame: Up to 28 days
Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death
Time frame: Up to 28 days
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
Time frame: Day 7
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
Time frame: Day 14
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
Time frame: Day 28
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
Time frame: Day 7, 14, 28, and 90
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
Time frame: Day 7, 14, 28, and 90
Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
Time frame: Day 7, 14, 28, and 90
Quality of Life (QOL) as Measured by the PROMIS-29 - Depression
Time frame: Day 7, 14, 28, and 90
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
Time frame: Day 7, 14, 28, and 90
Quality of Life (QOL) as Measured by the PROMIS-29 - Social
Time frame: Day 7, 14, 28, and 90
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep
Time frame: Day 7, 14, 28, and 90
Time Unwell in Days as Measured by the Symptom and Clinical Event Scale
Time frame: Up to 14 days
Mean Days Benefit as Measured by the Symptom and Clinical Event Scale
Time frame: Up to 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanna Naggie, MD principal investigator
Duke Clinical Research Institute
Adrian Hernandez, MD principal investigator
Duke Clinical Research Institute
87 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluticasone in people with Covid19, run by Susanna Naggie, MD at 87 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 87 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Sustained Recovery in Days (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.