Effect of Baloxavir on Flu Recovery in Hospitalized Patients
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
PHASE3 · University Hospital, Geneva · NCT06653569
This study is testing if an antiviral drug called baloxavir can help hospitalized adults with severe flu recover faster and have fewer complications.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 484 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Geneva (other) |
| Drugs / interventions | prednisone |
| Locations | 1 site (Geneva, Canton of Geneva) |
| Trial ID | NCT06653569 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of baloxavir marboxil, an antiviral medication, in reducing recovery time for hospitalized patients suffering from severe influenza. Participants will be randomly assigned to receive either baloxavir or a placebo to assess its impact on recovery duration, hospital stay length, and the risk of severe complications or death. The study aims to provide clearer evidence on the benefits of antiviral treatment in a population that has been under-researched. The trial is industry-independent and focuses on adult patients who have tested positive for influenza and require hospitalization.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are hospitalized with a confirmed influenza infection.
Not a fit: Patients who are pregnant, breastfeeding, or have known contraindications to baloxavir will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly shorten recovery times and reduce complications for hospitalized flu patients.
How similar studies have performed: Previous studies have shown mixed results regarding antiviral treatments for hospitalized flu patients, indicating a need for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * History of inclusion in this study during a previous influenza season * Inclusion in another interventional study with an investigational drug 30 days before inclusion in the study. * Unability to consent or patient representative unable to consent.
Where this trial is running
Geneva, Canton of Geneva
- Geneva University Hospitals — Geneva, Canton of Geneva, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Pauline Vetter, MD — University Hospital, Geneva
- Study coordinator: Pauline Vetter, MD
- Email: Pauline.Vetter@hug.ch
- Phone: +41 79 55 39 761
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Influenza Disease, Flu, antiviral treatment, baloxavir marboxil, influenza complications, hospitalization, severe influenza