ACTIV-6: COVID-19 Study of Repurposed Medications - Arm C (Fluticasone)
Condition: Covid19
MeSH terms: COVID-19
Intervention: Fluticasone; Placebo
Intervention description: 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.
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-Blind, Placebo-Controlled, Randomized Trial
Masking: Double (Participant, Care Provider)
Masking description: 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.
Enrollment: 1407.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: SARS-CoV-2; COVID-19; Placebo; Duke University Health System; Outcomes; Duke Clinical Research Institute; fluticasone; ACTIV 6; ACTIV

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.
    

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.]

        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