CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,407 enrolled
Drug / intervention
Fluticasone +1 moredrug
Likely dose
Fluticasone 200 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05736874
NCT05736874Phase 3Completed
CompareCT.gov

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

Susanna Naggie, MD·interventional·Posted Feb 21, 2023·Updated Jun 18, 2023

In Brief

A Phase 3 clinical trial evaluating Fluticasone and Placebo for Covid19. Completed, enrolled 1,407 participants across 87 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesUnited States
CollaboratorsNational Center for Advancing Translational Sciences (NCATS), Vanderbilt University Medical Center

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedFeb 21, 2023
Enrollment StartAug 6, 2021
Primary CompletionMar 17, 2022
Study CompletionMay 18, 2022
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.4 years ago

Interventions

Fluticasonedrug

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.