Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
5–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Index Patients (IPs):
Able to comply with the study protocol per investigator judgment.
Diagnosed with acute influenza infection by investigator.
Polymerase chain reaction \[PCR\] (+) or Rapid Influenza Diagnostic Test \[RIDT\] (+) for influenza A/B based on cobas® SARS-CoV-2 and influenza A/B or other point-of-care / local laboratory results.
PCR (-) or antigen test (-) for SARS-CoV-2 based on cobas® SARS-CoV-2 and Influenza A/B test or other point-of-care / local laboratory result
Presence of (a) fever (\>=38.0 °C per tympanic or rectal thermometer; \>=37.5 °C per axillary, oral or forehead/temporal thermometer) or (b) any influenza symptoms (cough, sore throat, nasal congestion, headache, feverishness or chills, muscle or joint pain, fatigue).
The time interval between the onset of fever or influenza symptoms and the pre-dose examinations is 48 hours or less.
Women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures specified in the protocol
All HHCs (Part 1):
PCR (-) or RIDT (-) based on cobas® SARS-CoV-2 and influenza A/B or other local point-of-care / local laboratory result.
PCR (-) or antigen test (-) for SARS-CoV-2 based on cobas® SARS-CoV-2 and Influenza A/B or other POC / local laboratory result.
Full study HHCs (part 2) intended for full study must meet the following additional criteria for study entry:
Agree to participate in the full study.
Able to comply with the study protocol per investigator judgment
No influenza symptoms within 7 days prior to screening. Alternatively, mild symptoms are permissible if determined by the investigator to be due to a preexisting condition.
Temperature \<38.0 °C (tympanic).
Will reside in the index patient's house for at least 7 of the next 9 days and will be present for scheduled study visits.
Willing and able to measure and record temperature, or have another household member perform the task on his or her behalf. Furthermore, a responsible adult will assume responsibility to oversee or perform this task on behalf of minors.
In the 6 months prior to screening: a) Has not been diagnosed with influenza by a healthcare professional b) Has not received BXM, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir, favipiravir or amantadine.
Does not have a moderate or worse active infections OR infections requiring systemic (e.g., oral or intravenous) or otherwise internally administered (e.g., inhaled, intrathecal) antibiotic/antiviral/antifungal therapy, (topical therapies for mild external infections allowed).
You may not be if
IPs:
IPs with severe influenza virus infection requiring inpatient treatment.
IPs judged by the investigator to be at high risk for complications of influenza.
IP is ≥12 years old and unable to swallow tablets (not applicable to IPs 5 to 11 year olds who will receive oral suspension).
Women who are breastfeeding or have a positive pregnancy test in the pre-dose examinations.
IPs with concurrent (non-influenza) infections requiring systemic antimicrobial and/or antiviral therapy at the pre-dose examinations.
IPs who have received baloxavir marboxil, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir, favipiravir or amantadine, or an investigational drug, within 30 days or 5 drug-elimination half-lives, whichever is longer, prior to screening.
IPs who have received an investigational monoclonal antibody for a viral disease in the last year.
Known hypersensitivity to baloxavir marboxil or the drug product excipients.
IP previously included in the study
HHC:
Pregnant or within 2 weeks post-partum at screening.
Immunocompromised.
Less than 2 years old.
Who have received an investigational therapy within the 30 days or 5 drug elimination half-lives, whichever is longer, prior to screening.
Diagnosed with influenza or SARS-CoV-2 infection by a healthcare professional in the past 4 weeks.
HHC who plans to arrive home after 24 hours post IP randomization to Day 9 and is not willing to be consented as soon as possible upon arrival.
HHC previously included in the study.
Clareo Health | Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households
