Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-24 @ 10:49 PM
NCT ID:
NCT06653569
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06653569
Study Brief:
Protocol Section:
NCT06653569