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

NCT06653569 | Recruiting Phase 3 DMC

• 2 other identifiers: 2024-0153533IC30_221790
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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

Influenza Disease; Flu

Keywords

antiviral treatment; baloxavir marboxil; influenza complications; hospitalization; severe influenza

Outcome Measures

Primary Outcomes (1)

• Time to clinical improvement

  The primary outcome is the time to clinical improvement, calculated from treatment administration, assessed by time to hospital discharge alive or time to a NEWS2 score of 2 or lower maintained for 24 h, whichever comes first.

  From treatment administration to hospital discharge or NEWS2 score of 2 or lower maintained for 24 h, whichever comes first, assessed up to day 90

Secondary Outcomes (10)

• Clinical status severity score

  At 7 days post treatment administration

• Duration of hospitalization

  From treatment administration to hospital discharge, assessed up to day 90

• Duration of Oxigen supplementation

  From treatment administration to waining of oxygen therapy, assessed up to day 90 (in patients requiring oxygen).

• In-hospital clinical failure

  From treatment administration to the end of hospital stay, maximum 30 days after treatment administration

• Mortality

  From treatment administration during 90 days

Other Outcomes (1)

• Serious adverse events, SAR and SUSAR

  From treatment administration to the end of hospital stay, maximum 30 days after treatment administration

Study Arms (2)

antiviral treatment

EXPERIMENTAL

baloxavir marboxil

Drug: Baloxavir Marboxil

placebo

PLACEBO COMPARATOR

Pacebo

Drug: Placebo

Interventions

Baloxavir Marboxil DRUG

The antiviral baloxavir marboxil administered in one unique dose. 1 capsule (40 mg) if participant weighs \< 80 kg; 2 capsules (80 mg) if participant weighs ≥ 80 kg

antiviral treatment

Placebo DRUG

Patients in the placebo group will receive one unique dose of placebo. 1 capsule if participant weighs \< 80 kg; 2 capsules (80 mg) if participant weighs ≥ 80 kg.

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Participant or participant representative capable of giving signed informed consent.
• Positive reverse transcriptase-polymerase chain reaction (RT-PCR) for influenza A and/or B confirmed on arespiratory tract sample.
• Patient requiring hospitalization.
• National Early Warning Score 2 (NEWS2) of ≥4 at planned randomization

You may not qualify if:

• Ongoing pregnancy or breastfeeding (self-reported by the participant or diagnosed by the treating phyisician)
• Known contraindication to baloxavir or to the placebo
• Participant weighing \< 40 kg
• Patients already on NAI therapy for the current influenza episode for \> 24 hours at the time of randomization.
• Prior treatment with baloxavir for the current influenza epidose
• Immunosuppression defined as 1) cancer treatment with significant negative effect on the immune system; 2) immunosuppressive therapy (treatments comprising a dose of ≥20 mg/day prednisone or equivalent when administered for ≥ 2 weeks, biological therapies, steroid sparing drugs); 3) HIV infection if CD4+ T cell count \< 500/µL; 4) organ or stem cell transplantation; 5) patients on the waiting list for a transplant
• Severe underlying respiratory comorbidity requiring long-term oxygenotherapy at home.
• Severe disease requiring ICU care directly at hospitalization.
• Severe hepatic insufficiency or any other severe medical condition when participation in the study puts the patient at risk according to the investigator's judgment.
• Unability to consent or patient representative unable to consent.

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Ticino, Switzerland: collaborator
• University of Zurich: collaborator
• University Hospital, Zürich: collaborator
• Centre Hospitalier Universitaire Vaudois (Switzerland): collaborator
• Dre Pauline Vetter: lead
• Swiss National Science Foundation: collaborator
• University Hospital, Geneva: collaborator
• University of Geneva, Switzerland: collaborator

Study Sites (1)

Geneva University Hospitals

Geneva, Canton of Geneva, 1205, Switzerland

RECRUITING

Related Publications (2)

• Hosszu-Fellous K, Vetter P, Agoritsas T, Kaiser L. Which trial do we need? Randomized, placebo-controlled trial of antiviral treatment in patients hospitalized for influenza. Clin Microbiol Infect. 2024 May;30(5):567-569. doi: 10.1016/j.cmi.2024.01.025. Epub 2024 Feb 3. No abstract available.

  PMID: 38316358 BACKGROUND

• Hosszu-Fellous K, Poncet A, Cabecinhas ARG, Schibler M, Meyer B, Prendki V, Huttner A, Carballo S, Pouillon M, Slankamenac K, Bart PA, Bernasconi E, Manuel O, Mombelli M, Mueller NJ, Kaiser L, Vetter P. Antiviral treatment in adult patients hospitalized for influenza: study protocol for a multi-center, randomized, placebo-controlled trial on the efficacy of baloxavir marboxil to reduce time to clinical improvement and the risk for severe complications (the INFLUENT trial). Trials. 2025 Nov 24;26(1):538. doi: 10.1186/s13063-025-09248-0.

  PMID: 41286959 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

baloxavir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Pauline Vetter, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

• Nicolas Muller, Professor

  Department of Infectious Diseases and Hospital epidemiology, University Hospital Zürich

  PRINCIPAL INVESTIGATOR

• Matteo Mombelli, MD

  Department of internal medicine, Locarno Regional Hospital EOC

  PRINCIPAL INVESTIGATOR

• Oriol Manuel, Pr

  Center for organ transplantation, Lausanne University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pauline Vetter, MD

CONTACT

+41 79 55 39 761; Pauline.Vetter@hug.ch

Krisztina Hosszu-Fellous, MD

CONTACT

+41795522953; krisztina.hosszu-fellous@hug.ch

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior staff physician

Model Details: Placebo-controlled

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 22, 2024
• Study Start: December 13, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and up to 10 years after publication.
• Access Criteria: IPD can be shared with investigators whose proposed use of the data has been approved by an independent review committee. The approval of the biobank regulation committee, which includes the coordinating PI, the sites PI and the responsibles of the biobank is also required on a case by case basis.

Locations

CH (1)