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

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:

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

• Influenza Disease; Flu

Interventions

DRUG

Baloxavir Marboxil

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

DRUG

Placebo

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.

Sponsors & Collaborators

• Swiss National Science Foundation

  collaborator OTHER

• University Hospital, Geneva

  collaborator OTHER

• University of Geneva, Switzerland

  collaborator OTHER

• Ente Ospedaliero Cantonale, Ticino, Switzerland

  collaborator OTHER

• Centre Hospitalier Universitaire Vaudois (Switzerland)

  collaborator UNKNOWN

• University of Zurich

  collaborator OTHER

• University Hospital, Zürich

  collaborator OTHER

• Dre Pauline Vetter

  lead OTHER

Principal Investigators

• Pauline Vetter, MD · University Hospital, Geneva

• Nicolas Muller, Professor · Department of Infectious Diseases and Hospital epidemiology, University Hospital Zürich

• Matteo Mombelli, MD · Department of internal medicine, Locarno Regional Hospital EOC

• Oriol Manuel, Pr · Center for organ transplantation, Lausanne University Hospitals

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-13

Primary Completion

2027-04-30

Completion

2027-09-30

Countries

• Switzerland

Study Locations