Phase 3
Completed N=1,407
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm C (Fluticasone)
Source: ClinicalTrials.gov NCT05736874 ↗Enrolled (actual)
1,407
Serious AEs
0.8%
Results posted
Apr 2023
Primary outcomePrimary: Time to Sustained Recovery in Days — 12; 13 days
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Sustained Recovery in Days |
12; 13 | — |
| SECONDARY Number of Participants With Hospitalization or Death |
3; 3 | — |
| SECONDARY Number of Participants With Mortality |
0; 0 | — |
| SECONDARY Time to Mortality |
— | — |
| SECONDARY Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death |
24; 13 | — |
| SECONDARY Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7 |
42; 27; 567; 546; 42; 43 | — |
| SECONDARY Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14 |
64; 41; 566; 547; 19; 26 | — |
| SECONDARY Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28 |
0; 0; 579; 574; 11; 6 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function |
20; 20; 20; 20; 20; 20 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue |
9; 8; 7; 7; 5; 5 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Pain |
6; 5; 4; 4; 4; 4 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Depression |
4; 4; 4; 4; 4; 4 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety |
5; 5; 4; 4; 4; 4 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Social |
17; 17; 20; 20; 20; 20 | — |
| SECONDARY Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep |
10; 10; 9; 9; 8; 8 | — |
| SECONDARY Time Unwell in Days as Measured by the Symptom and Clinical Event Scale |
11.2; 11.3 | — |
| SECONDARY Mean Days Benefit as Measured by the Symptom and Clinical Event Scale |
3.50; 3.37 | — |
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
Data sourced from ClinicalTrials.gov (NCT05736874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.