A Swiss Multi-center, Randomized, Placebo-controlled Trial on the Efficacy of Baloxavir Marboxil to Reduce Time to Clinical Improvement in Adult Patients Hospitalized for Influenza

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
Geneva University Hospitals
RECRUITING
Geneva
Contact Information
Primary
Pauline Vetter, MD
Pauline.Vetter@hug.ch
+41 79 55 39 761
Backup
Krisztina Hosszu-Fellous, MD
krisztina.hosszu-fellous@hug.ch
+41795522953
Time Frame
Start Date: 2024-12
Estimated Completion Date: 2027-09
Participants
Target number of participants: 484
Treatments
Experimental: antiviral treatment
baloxavir marboxil
Placebo_comparator: placebo
Pacebo
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital, Geneva, Swiss National Science Foundation, Ente Ospedaliero Cantonale, Ticino, Switzerland, Universitätspital Zürich, (Switzerland), University of Zurich, University of Geneva, Switzerland, Centre Hospitalier Universitaire Vaudois (Switzerland)
Leads: Dre Pauline Vetter

This content was sourced from clinicaltrials.gov