Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06653569

Efficacy of Baloxavir Against Influenza in Hospitalized Patients: The INFLUENT Study (INpatients inFLUENza Treatment)

Led by Dre Pauline Vetter · Updated on 2026-05-01

484

Participants Needed

1

Research Sites

141 weeks

Total Duration

On this page

Sponsors

D

Dre Pauline Vetter

Lead Sponsor

S

Swiss National Science Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this clinical trial is to find out if the medication called baloxavir marboxil (sold under the brand name Xofluza®) can help to reduce the time needed to recover from flu when patients need an hospitalization. Patients infected by influenza and requiring a hospitalization will be approched to be included in the study. The main questions are: 1. When someone is hospitalized with a severe influenza infection, does baloxavir help to reduce the time needed to recover? 2. Can baloxavir marboxil help to shorten the amount of time people need to stay in the hospital with severe flu? 3. Can baloxavir marboxil help to reduce the risk of life-threatening complications as well as of death due to severe flu? 4. Can baloxavir reduce duration of contagiousness? To be able to measure the above, the investigators will compare two groups of patients: One group receiving baloxavir marboxil, the other group receiving a mock treatment called placebo. Participants will: * Take one single dose of baloxavir marboxil or placebo soon after hospitalization. * Vital signs will be followed three times per day during hospital stay. * Have a nose swab to detect the presence of influenza virus on the first and third day of trial participation. * Answer to a short quality of life questionnaire on the phone 3 months after receiving the study treatment.

CONDITIONS

Official Title

Efficacy of Baloxavir Against Influenza in Hospitalized Patients: The INFLUENT Study (INpatients inFLUENza Treatment)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years
  • Ability of participant or representative to give signed informed consent
  • Positive test confirming influenza A or B infection from respiratory sample
  • Patient requiring hospitalization
  • National Early Warning Score 2 (NEWS2) of 4 or higher at planned randomization
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Known allergy or contraindication to baloxavir or placebo
  • Participant weighing less than 40 kg
  • Current use of neuraminidase inhibitor therapy for this flu episode for more than 24 hours prior to randomization
  • Prior baloxavir treatment for this influenza episode
  • Immunosuppression due to cancer treatment, immunosuppressive therapy, HIV with low CD4 count, transplantation or transplant waiting list
  • Severe chronic respiratory disease requiring long-term oxygen therapy at home
  • Severe illness requiring ICU care at hospital admission
  • Severe liver failure or other severe medical conditions putting patient at risk
  • Previous participation in this study during a prior influenza season
  • Participation in another interventional drug study within 30 days prior to inclusion
  • Inability of participant or representative to provide informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Geneva University Hospitals

Geneva, Canton of Geneva, Switzerland, 1205

Actively Recruiting

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Research Team

P

Pauline Vetter, MD

CONTACT

K

Krisztina Hosszu-Fellous, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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