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NCT03684044 · ClinicalTrials.gov registry record · Phase 3
Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza
A Phase 3 study of Influenza, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 363
- Enrollment target
- 20
- Study locations
NCT03684044: Completed Phase 3 study of Influenza, sponsored by Hoffmann-La Roche.
NCT03684044 is a Phase 3 study of Influenza that has completed, run by Hoffmann-La Roche. The registered enrollment target is 363 participants, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03684044, a Phase 3 study of Influenza, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 363 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of baloxavir marboxil in combination with a standard-of-care (SOC) neuraminidase inhibitor (NAI) (i.e., oseltamivir, zanamivir, or peramivir) compared with a matching placebo in combination with a SOC NAI in hospitalized patients with influenza.
Primary Outcome
Time to Clinical Improvement (TTCI) is defined as Time to Hospital Discharge OR Time to NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Baloxavir Marboxil
Study Locations (20)
Other
- Instituto Medico Platense - La Plata
- Hopital Erasme; Chest Medicine, Cardiac & Thoracic Surgery - Brussels
- Cliniques Universitaires Saint-Luc; Hematology - Brussels
- UZ Leuven - Leuven
Illinois
- University of Chicago; Oncology Dept - Chicago
- NorthShore University HealthSystem - Evanston
California
- Torrance Memorial Medical Center - Torrance
Colorado
- Denver Health Medical Center - Denver
Georgia
- Atlanta Institute For Medical Research, Inc; DeKalb Medical Pharmacy - Decatur
Louisiana
- Barnum Medical Research, Inc. - Natchitoches
Michigan
- Detroit Receiving Hospital - Detroit
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 363 participants |
| Start Date | 2019-01-08 |
| Est. Completion | 2020-03-16 |
| Phase | Phase 3 |
What the finished NCT03684044 record still lists
NCT03684044 is an interventional study that assigns participants to a tested intervention. The registered 363 participants enrollment target is mid-sized for trials with a published cap, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03684044 names 20 study sites across 16 states, led by Other, Illinois, California.
Frequently Asked Questions
What is clinical trial NCT03684044 about?
NCT03684044 is a clinical study titled "Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza". This study will evaluate the efficacy, safety, and pharmacokinetics of baloxavir marboxil in combination with a standard-of-care (SOC) neuraminidase inhibitor (NAI) (i.e., oseltamivir, zanamivir, or peramivir) compared with a matching placebo in combination with a SOC NAI in hospitalized patients wi...
What is the current status of trial NCT03684044?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 363 participants. The study started on 2019-01-08. Estimated completion is 2020-03-16.
What conditions does trial NCT03684044 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT03684044?
The interventions under investigation include: Placebo (OTHER), Baloxavir Marboxil (DRUG).
Who is sponsoring clinical trial NCT03684044?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03684044 being conducted?
This trial has 20 study locations across California, Colorado, Georgia, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03684044's enrollment target sits among peer trials
363 55th of 156 higher than 102 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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