Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza
Public ClinicalTrials.gov record NCT03684044. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Double-Blind Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety of Baloxavir Marboxil in Combination With Standard-of-Care Neuraminidase Inhibitor in Hospitalized Participants With Severe Influenza
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03684044
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 363 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 7, 2019
- Primary completion
- Mar 15, 2020
- Completion
- Mar 15, 2020
- Last update posted
- Jan 5, 2021
2019 – 2020
United States locations
- U.S. sites
- 14
- U.S. states
- 13
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Torrance Memorial Medical Center | Torrance | California | 90505 | — |
| Denver Health Medical Center | Denver | Colorado | 80204 | — |
| Atlanta Institute For Medical Research, Inc; DeKalb Medical Pharmacy | Decatur | Georgia | 30030 | — |
| University of Chicago; Oncology Dept | Chicago | Illinois | 60637 | — |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | — |
| Barnum Medical Research, Inc. | Natchitoches | Louisiana | 71457 | — |
| Detroit Receiving Hospital | Detroit | Michigan | 48201 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Mercury Street Medical Group | Butte | Montana | 59701 | — |
| Creighton University Medical Center | Omaha | Nebraska | 68131 | — |
| New York-Presbyterian Brooklyn Methodist Hospital; Department of Emergency Medicine | Brooklyn | New York | 11215 | — |
| Temple University Hospital ; Lung Center | Philadelphia | Pennsylvania | 19140 | — |
| Salem Veterans Affairs Medical Center - NAVREF; Pharmacy | Salem | Virginia | 24153 | — |
| Froedtert and The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 156 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03684044, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 5, 2021 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03684044 live on ClinicalTrials.gov.