Effect of Baloxavir on Flu Recovery in Hospitalized Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Preparedness through community respiratory virus testing and engagement

  This program will offer community members regular testing for respiratory viruses like COVID-19, flu, and RSV and invite some people to join longer-term monitoring and household transmission follow-up.

  Recruiting at 2 sites University of California, San Diego · La Jolla, California and 1 other locations · NCT07147517

• Fixed-dose combo pill for cold and flu symptoms in adults

  A 3rd-phase study will test whether a fixed-dose pill containing dipyrone monohydrate, caffeine, and chlorpheniramine helps adults with nasal congestion and other cold/flu symptoms.

  Recruiting Phase 3 Brainfarma Industria Química e Farmacêutica S/A · Belo Horizonte, Minas Gerais and 14 other locations · NCT07626437

• Measuring flu vaccine immunity in COVID-19 patients

  This study looks at how well the flu vaccine works in people aged 13 to 64 who have had COVID-19, comparing their immune responses to those who haven't had the virus.

  Recruiting Stanford University · Palo Alto, California · NCT04579588

• High-dose vs standard-dose flu vaccine in adults with blood cancers on B-cell-depleting therapy

  This study tests whether a high-dose flu shot evokes a stronger immune response than a standard-dose shot in adults with hematologic cancers who recently had B-cell-depleting therapy.

  Recruiting Phase 2 Asan Medical Center · Seoul · NCT07926217

• Abbott ID NOW at the point of care for flu-like illness in long-term care facilities

  This trial tests whether the Abbott ID NOW rapid test at the point of care in long-term care facilities can help identify influenza sooner for residents 65 and older with fever and respiratory symptoms.

  Recruiting China Medical University Hospital · Taichung · NCT07846423

• Egg-based H5N8 influenza vaccine at multiple doses with or without adjuvant in healthy adults

  This trial tests whether an egg-based H5N8 flu vaccine, given at low to high doses with or without an adjuvant, is safe and can provoke a stronger immune response in healthy adults 18 and older.

  Recruiting at 16 sites Phase 1/2 Sanofi · Tempe, Arizona and 15 other locations · NCT07779408

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.