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ACTIV-6: Fluticasone for COVID-19
NCT05736874Phase 3
Key facts
- Status
- Completed
- Start
- Aug 2021
- Primary completion
- Mar 2022
- Countries
- 1
- Modality
- Orthosteric Ligands
- Drugs
- fluticasone
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 3, randomised, double-blind trial in coronavirus disease 2019 (COVID-19) comparing Fluticasone Arm with Placebo Arm (2 arms). Primary endpoint: Time to Sustained Recovery up to 28 days. Started Aug 2021; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Fluticasone Arm
Fluticasone furoate 200 µg inhaled once daily.
Placebo Arm
Inhaled placebo once daily.
03
Who it enrols
Inclusion requires confirmed SARS-CoV-2 infection within 10 days and 2+ symptoms for <= 7 days. Exclusion includes prior COVID-19 > 10 days, current hospitalization, severe milk protein allergy, and nursing mothers.
04
Endpoints
Primary
Time to Sustained Recovery
Secondary
Number of Participants With Hospitalization or Death
Number of Participants With Mortality
Time to Mortality
Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death
Number of Participants at Each Score on the COVID Clinical Progression Scale
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
Time Unwell in Days as Measured by the Symptom and Clinical Event Scale
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