Influenza, Human, Respiratory Tract Infections, Post-exposure Prophylaxis
Conditions
Keywords
Influenza, Baloxavir Marboxil, Household Contacts
Brief summary
The main purpose of the study is to evaluate the efficacy of a single dose of baloxavir marboxil compared with placebo in the PEP of influenza virus infection with respect to symptomatic, laboratory-confirmed influenza in participants who are household contacts (HHCs) of participants with influenza (index participants).
Interventions
Baloxavir marboxil will be administered to the HHCs as per the schedule specified in the protocol.
DRUGPlacebo
Baloxavir marboxil matching placebo will be administered to the HHCs as per the schedule specified in the protocol.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The sponsor and its agents will also be blinded to treatment assignment.
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Index Participants (Participants With Influenza Virus Infection): * First participant in a household with influenza virus infection in the current influenza season * Fewer than 6 HHCs * Agreement by all household members to participate in the study and comply with the study protocol for the duration of the study * Diagnosed as having influenza with positive rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) result * Onset of symptoms within 48 hours or less at time of signing Informed Consent Form (ICF)/Assent Form * PCR (-) or antigen test (-) for severe acute respiratory virus-coronavirus 2 (SARS-CoV-2) using point-of-care or local laboratory test HHCs of Index Participants: * Lived with the index participant for 48 hours or more prior to informed consent/assent * Meet all the following criteria and are judged not to have influenza virus infection by the investigator: body temperature (tympanic) \<37.5 degrees Celsius (°C); no influenza-like symptoms (cough, sore throat, headache, nasal discharge/nasal congestion, feverishness or chills, muscle or joint pain, or fatigue) at screening; negative RIDT or PCR result for influenza * For participants 12 years of age or older, ability to evaluate influenza symptoms by using a participant influenza symptoms diary; For participants under 12 years of age, capability of parents/caregivers to evaluate influenza symptoms by using a participant influenza symptoms diary * PCR (-) or antigen test (-) for SARS-CoV-2 using point-of-care or local laboratory test
Exclusion criteria
HHCs of Index Participants: * Diagnosed with influenza during the current influenza season * Unable to live with the index patient from screening until Day 10 * Live with a household member who has any influenza-like symptom(s) other than the index participant on the day of screening * Live with household members other than the index participant who was diagnosed with or strongly suspected to have influenza during the current influenza season * Have any underlying diseases requiring systemic (oral or injection), or nasal treatment of antipyretics/analgesics, corticosteroids, or immunosuppressive agents * Immunocompromised * Use of any medications with anti-influenza effect within 30 days prior to screening * Known allergy and/or history of significant intolerance against baloxavir marboxil * Exposure to an investigational drug within 30 days or 5 half-lives of the drug prior to screening, whichever is longer Note: Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants who are Infected With Influenza Virus (Reverse Transcription - Polymerase Chain Reaction [RT-PCR] Positive), and Present With Fever and at Least one Respiratory Symptom | From Day 1 up to Day 10 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants who are Infected With Influenza Virus (RT-PCR Positive), and Present With Fever or at Least one Influenza Symptom (Respiratory or Systemic) | From Day 1 up to Day 10 |
| Percentage of Participants who are Infected With Influenza Virus (RT-PCR Positive) Regardless of Body Temperature or Influenza Symptoms | From Day 1 up to Day 10 |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Day 21 |
Countries
China
Contacts
CONTACTRoche Pharma (Schweiz) AG Reference Study ID Number: YV46459, https://forpatients.roche.com/
CONTACTFastest response: use the inquiry form https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed