Can a single pill speed up severe flu recovery?
NCT ID NCT06653569
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a single dose of baloxavir marboxil (Xofluza) can help adults hospitalized with severe flu recover faster. About 484 participants in Switzerland will receive either the drug or a placebo. Researchers will measure time to clinical improvement, hospital stay length, and complication rates.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- baloxavir marboxil (Xofluza)
- What this could lead to
- If it works, this could provide a faster recovery option for people hospitalized with severe flu, reducing hospital stays and complications.
- What could go wrong
- This is a Phase 3 trial, but results may not apply to all flu strains or patient groups. The placebo group also receives standard care, so the added benefit may be small.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 484 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Geneva University Hospitals
RECRUITINGGeneva, Canton of Geneva, 1205, Switzerland