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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

Efficacy of Baloxavir Against Influenza in Hospitalized Patients: the INFLUENT Study (INpatients InFLUENza Treatment)

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

Efficacy of Baloxavir Against Influenza in Hospitalized Patients: the INFLUENT Study (INpatients InFLUENza Treatment) (NCT06653569) is a Phase 3 interventional studying Influenza Disease; Flu, sponsored by Dre Pauline Vetter. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Influenza Disease; Flu, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 484 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥ 18 years - Participant or participant representative capable of giving signed willing to sign a consent form. - 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Geneva University Hospitals
Geneva, Canton of Geneva, Switzerland

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06653569), the sponsor (Dre Pauline Vetter), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06653569 clinical trial studying?

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? … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06653569?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06653569?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06653569. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06653569. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.