Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle

• Status: Completed
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Collaborator: Genentech, Inc.
• Treatments: Baloxavir

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