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

• Status: Completed
• Trial end date: 2022-05-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Susanna Naggie, MD
• Collaborators: National Center for Advancing Translational Sciences (NCATS); Vanderbilt University Medical Center
• Treatments: Fluticasone; Xhance

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