Swiss multicenter randomized placebo-controlled clinical trial to evaluate the efficacy of baloxavir in reducing the time to clinical improvement in hospitalized patients with influenza.
Summary description of the study
The influenza virus is a major source of seasonal epidemics and is the primary candidate for a future pandemic. Every winter, thousands of people are hospitalized due to infectious complications. There is still much to learn about the treatment of influenza with antiviral medications. Most studies have focused on the benefits of antiviral treatment in patients with mild illness who did not require hospitalization. They have shown a slight therapeutic advantage when the antiviral medication is started early (less than 2 days after the onset of symptoms). Clinical research involving hospitalized patients with influenza complications is rarer and of lower quality, and there is no certainty about the benefits of treatment when the antiviral medication is administered to hospitalized individuals. There is a lack of high-quality placebo-controlled studies in hospitalized patients with influenza to answer this question. Therefore, hospital physicians lack solid guidance for treating patients who arrive at the hospital due to their illness. This study aims to provide an answer to this question. It could lead to a Swiss and international consensus on the role of antiviral treatment in hospitalized patients.
(BASEC)
Intervention under investigation
The studied drug is baloxavir marboxil, an antiviral that inhibits the replication of the influenza virus (the influenza virus). This treatment is already approved in Switzerland under the trade name Xofluza® for the treatment of uncomplicated influenza in individuals whose symptoms have lasted for less than 48 hours. Participants randomized to the treatment group will receive a single dose of baloxavir marboxil adjusted to their weight: <80 kg: 1 tablet of 40 mg, ≥80 kg: 2 tablets of 40 mg. The treatment is taken orally. To ensure that the study is conducted in a blind manner, meaning that no one is aware of who is taking the treatment or the placebo, the baloxavir tablets are inserted into capsules similar to the placebo. In the control group, participants will receive a single dose of placebo. The number of placebo capsules will depend on weight: <80 kg: 1 capsule of 40 mg, ≥80 kg: 2 capsules of 40 mg.
(BASEC)
Disease under investigation
Influenza
(BASEC)
- Adults requiring hospitalization due to influenza - Influenza confirmed by a PCR test performed on a respiratory swab - Clinical severity score called NEWS2 >= 4 (BASEC)
Exclusion criteria
- presence of immunosuppression - pregnancy or postpartum - participants already treated with an active antiviral against influenza for more than 24 hours (BASEC)
Trial sites
Geneva, Lausanne, Lugano, Zurich, Other
(BASEC)
Locarno (Ente Ospidaliero Cantonale, EOC), Troinex (Hôpital des 3 Chêne, HUG, Genève)
(BASEC)
Sponsor
Geneva University Hospitals
(BASEC)
Contact
Contact Person Switzerland
Dre Pauline Vetter
+41 79 55 39 761
pauline.vetter@clutterhug.chHôpitaux Universitaires de Genève
(BASEC)
General Information
University Hospital, Geneva,Department of Infectious Diseases and Hospital epidemiology, University Hospital Z?rich,Department of internal medicine, Locarno Regional Hospital EOC,Center for organ transplantation, Lausanne University Hospitals,
+41 79 55 39 761;+41(0)795539761
pauline.vetter@clutterhug.ch(ICTRP)
Scientific Information
University Hospital, Geneva,Department of Infectious Diseases and Hospital epidemiology, University Hospital Z?rich,Department of internal medicine, Locarno Regional Hospital EOC,Center for organ transplantation, Lausanne University Hospitals,
+41 79 55 39 761;+41(0)795539761
pauline.vetter@clutterhug.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Geneva
(BASEC)
Date of authorisation
06.11.2024
(BASEC)
ICTRP Trial ID
NCT06653569 (ICTRP)
Official title (approved by ethics committee)
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 - the INFLUENT trial (BASEC)
Academic title
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 (ICTRP)
Public title
Efficacy of Baloxavir Against Influenza in Hospitalized Patients: the INFLUENT Study (INpatients InFLUENza Treatment) (ICTRP)
Disease under investigation
Influenza Disease; Flu (ICTRP)
Intervention under investigation
Drug: Baloxavir Marboxil;Drug: Placebo (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
Gender: All
Maximum age: N/A
Minimum age: 18 Years
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/?L;
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. (ICTRP)
not available
Primary and secondary end points
Time to clinical improvement (ICTRP)
Clinical status severity score;Duration of hospitalization;Duration of Oxigen supplementation;In-hospital clinical failure;Mortality;Influenza-related complications;Antibiotic consumption;Quality of life;Viral shedding;Duration of infectious viral shedding (ICTRP)
Registration date
18.10.2024 (ICTRP)
Incorporation of the first participant
not available
Secondary sponsors
Swiss National Science Foundation;University Hospital, Geneva;University of Geneva, Switzerland;Ente Ospedaliero Cantonale, Ticino, Switzerland;Centre Hospitalier Universitaire Vaudois (Switzerland);Universit?tspital Z?rich, (Switzerland);University of Zurich (ICTRP)
Additional contacts
Pauline Vetter, MD;Nicolas Muller, Professor;Matteo Mombelli, MD;Oriol Manuel, Pr;Pauline Vetter, MD;Pauline Vetter, Pauline.Vetter@hug.ch; pauline.vetter@hug.ch, +41 79 55 39 761;+41(0)795539761, University Hospital, Geneva,Department of Infectious Diseases and Hospital epidemiology, University Hospital Z?rich,Department of internal medicine, Locarno Regional Hospital EOC,Center for organ transplantation, Lausanne University Hospitals, (ICTRP)
Secondary trial IDs
33IC30_221790, 2024-01535 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06653569 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available