Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle
Condition: Influenza; Respiratory Viral Infection
MeSH terms: Influenza, Human; Virus Diseases
Intervention: Baloxavir Marboxil
Intervention description: Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset
Intervention MeSH terms: Baloxavir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 481.0
Sex: All
Minimum age: 3 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza; flu; antiviral; baloxavir; Xofluza; rapid delivery; self-test

Summary:

      This study will evaluate a home-based approach to influenza infection control, using
      prepositioned home-based influenza self-test kits, telemedicine services, and rapid delivery
      of Xofluza (Baloxavir marboxil) for administration within 48 hours of symptom onset.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Household Level:

          -  Group of at least 3 individuals of any ages defined as at least 3 persons residing at
             the same address for at least 4 days per calendar week

          -  Household group utilizes common household areas

          -  At least 2 household members meeting all individual inclusion/exclusion criteria
             listed below and willing to participate (e.g. at least two members of the household
             are 12 years of age or older)

          -  At least one member of the household has a smartphone

          -  Individual Level: Drug Eligible

          -  Resident of a household with 3 or more members (including eligible cases) for 4 or
             more days a calendar week

          -  Age 12 years or older weighing at least 40 kg (greater than 88 pounds)

          -  Willing and able to take study medication

          -  Willing to comply with all study procedures

          -  English-speaking

          -  Able to provide written, informed consent and/or assent (if applicable)

          -  Permanent mailing address that is available for study staff to mail necessary
             materials

          -  Individual Level: Drug Ineligible

          -  Resident of a household with 3 or more members (including eligible cases) for 4 or
             more days a calendar week

          -  Willing to comply with all study procedures

          -  English-speaking

          -  Able to provide written, informed consent and/or assent (if applicable)

        Exclusion Criteria:

          -  Household Level:

          -  Previous documentation of an influenza infection prior to or during the annual
             influenza season in any household member prior to enrollment

          -  Individual Level:

          -  Any serious or uncontrolled medical disorder or active infection that, in the opinion
             of the investigator, may increase the risk associated with study participation or
             study drug administration

          -  Individuals with hypersensitivity to baloxavir

          -  Individuals that already have a tele-health account

          -  Any individual that has one or more of the following conditions:

          -  Pregnant

          -  Currently lactating

          -  Immunosuppressed or immunocompromised (by disease or medication)

          -  Cancer

          -  Liver disease

          -  Kidney disease