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

Completed · Phase 3 · Has a placebo group

Conditions studied: Covid19

In brief

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.

Key facts

Study ID

NCT05736874

Run by

Susanna Naggie, MD

People needed

1407

Starts

2021-08-06

Expected to finish

2022-05-18

Last updated by the study team

2023-06-18

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

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.]
• 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

Where it is running

• 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
• Lamb Health, LLC — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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