ACTIV-6: COVID-19 Study of Repurposed Medications - Arm C (Fluticasone)

NCT ID: NCT05736874

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1407 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-06
• Study Completion Date: 2022-05-18

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm C - Fluticasone

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 Type: EXPERIMENTAL

Fluticasone

Intervention Type: DRUG

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.

Arm C - Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

Interventions

Fluticasone

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: OTHER

Other Intervention Names

Fluticasone Furoate

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: collaborator

Susanna Naggie, MD

OTHER

Sponsor Role: lead

Responsible Party

Susanna Naggie, MD

Associate Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Susanna Naggie, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institute

Adrian Hernandez, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institute

Locations

Lamb Health, LLC

Gilbert, Arizona, United States

First Care Medical Clinic

Mesa, Arizona, United States

Trident Health Center

Peoria, Arizona, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Assuta Family Medical Group APMC

North Hollywood, California, United States

Stanford

Palo Alto, California, United States

Doctors Medical Group of Colorado Springs, P.C.

Colorado Springs, Colorado, United States

Pine Ridge Family Medicine Inc.

Colorado Springs, Colorado, United States

Tabitha B. Fortt, M.D., LLC

Stamford, Connecticut, United States

George Washington University Hospital

Washington D.C., District of Columbia, United States

Lupus Foundation of Gainesville

Gainesville, Florida, United States

University of Florida Health

Gainesville, Florida, United States

University of Florida-JAX-ASCENT

Jacksonville, Florida, United States

AMRON Vitality and Wellness Center, LLC

Jacksonville, Florida, United States

Sunshine Walk In Clinic

Lake Mary, Florida, United States

Lakeland Regional Medical Center

Lakeland, Florida, United States

Jackson Memorial Hospital

Miami, Florida, United States

University of Miami

Miami, Florida, United States

Well Pharma Medical Research

Miami, Florida, United States

Innovation Clinical Trials Inc.

Palmetto Bay, Florida, United States

Lice Source Services Plantation

Plantation, Florida, United States

Premier Health

St. Petersburg, Florida, United States

Tallahassee Memorial Hospital

Tallahassee, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

UF Health Precision Health Research

The Villages, Florida, United States

Emory Healthcare

Atlanta, Georgia, United States

Essential Medical Care, Inc.

College Park, Georgia, United States

David Kavtaradze MD, Inc.

Cordele, Georgia, United States

Elite Family Practice

Douglasville, Georgia, United States

Christ the King Health Care, P.C.

Loganville, Georgia, United States

Miller Family Practice, LLC

Macon, Georgia, United States

Olivo Wellness Medical Center

Chicago, Illinois, United States

NorthShore Medical Group

Evanston, Illinois, United States

Advanced Medical Care, Ltd

Lake Zurich, Illinois, United States

Franciscan Health Michigan City

Michigan City, Indiana, United States

Del Pilar Medical and Urgent Care

Mishawaka, Indiana, United States

University of Kansas - Wichita

Wichita, Kansas, United States

A New Start II, LLC

Central City, Kentucky, United States

University Medical Center- New Orleans

New Orleans, Louisiana, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Jadestone Clinical Research, LLC

Rockville, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Health Quality Primary Care

Lawrence, Massachusetts, United States

Ananda Medical Clinic

Dearborn, Michigan, United States

GFC of Southeastern Michigan, PC

Detroit, Michigan, United States

Romancare Health Services

Detroit, Michigan, United States

Essentia Health

Duluth, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

University of Missouri - Columbia

Columbia, Missouri, United States

Comprehensive Pain Management and Endocrinology

Henderson, Nevada, United States

Focus Clinical Research Solutions

Bayonne, New Jersey, United States

Raritan Bay Primary Care & Cardiology Associates

Matawan, New Jersey, United States

Mediversity Healthcare

Turnersville, New Jersey, United States

Geriatrics and Medical Associates

Clinton, New York, United States

Weill Cornell Medical College

New York, New York, United States

Spinal Pain and Medical Rehab, PC

Yonkers, New York, United States

Vaidya MD PLLC

Clayton, North Carolina, United States

Maria Medical Center, PLLC

Dunn, North Carolina, United States

Duke Clinical Research Institute

Durham, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Diabetes and Endocrinology Assoc. of Stark County

Canton, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

TriHealth, Inc

Montgomery, Ohio, United States

The Heart and Medical Center

Durant, Oklahoma, United States

Hugo Medical clinic

Hugo, Oklahoma, United States

Bucks County Clinical Research

Morrisville, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Clinical Trials Center of Middle TN

Franklin, Tennessee, United States

Rapha Family Wellness

Hendersonville, Tennessee, United States

Medical Specialists of Knoxville

Knoxville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Express Family Clinic

Allen, Texas, United States

Texas Tech University Health Sciences Center

El Paso, Texas, United States

Texas Health Physicians Group

Fort Worth, Texas, United States

Highlands Medical Associates, P.A.

Highlands, Texas, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

Family Practice Doctors P.A.

Humble, Texas, United States

Vytalus Medical Group

Humble, Texas, United States

Texas Health Physicians Group

Irving, Texas, United States

University Diagnostics and Treatment Clinic

Pasadena, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Jeremy W. Szeto, D.O., P.A.

Sugar Land, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

3U24TR001608-05W1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00107921_C

Identifier Type: -

Identifier Source: org_study_id