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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
Households represent an important location for transmission of influenza. Rapid delivery of Xofluza may reduce household exposures to influenza among susceptible individuals.This study is a pilot study of a home-based approach to influenza infection control, utilizing self-test kits and rapid home delivery of an antiviral. Households with at least 3 individuals residing there at least 4 days a week, including at least 2 household members that are eligible to take antiviral, will be monitored throughout the influenza season for the onset of a cough or two or more acute respiratory infection symptoms. This study will be conducted in households in the Seattle, WA area for one influenza season, beginning November 1, 2019 and ending April 1, 2020. Household will self-monitor for onset of symptoms throughout the influenza season. When symptoms develop, the participant will self-test for influenza infection using a prepositioned home-testing kit. If negative, the ill participant will provide one self-collected nasal swab specimen. If positive, the ill participant will connect with a healthcare provider via the tele-health app on their smartphone to confirm the influenza diagnosis. Next, if eligible to receive Xofluza, the influenza-positive individual will receive a rapid home delivery of Xofluza within 2-6 hours of the positive test result. All influenza-positive participants will provide a self-collected nasal swab specimen at Study Day 0, Study Day 2-3, and Study Day 5-7. For all illness episodes, the ill individual will complete a questionnaire regarding symptom duration and severity, as well as behavioral changes due to illness.

Official Title
-----------------
Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle (pCHIMES)

Conditions
-----------------
Influenza, Respiratory Viral Infection

Intervention / Treatment
-----------------
* Drug: Baloxavir Marboxil


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 3 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study Drug Eligible<br>Baloxavir given in 40 mg and 80 mg tablets for single-dose oral consumption during the first influenza infection for that participant | Drug: Baloxavir Marboxil<br>* Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset<br>* Other names: Xofluza;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiate Antiviral Therapy Within 48 Hours of Symptom Onset | Among symptomatic participants, this outcome measure will be calculated by determining the number of home influenza test-positive, drug eligible participants that were prescribed and rapidly delivered baloxavir by the study within 48 hours of symptom onset. | Up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Home Influenza Tests Confirmed by Laboratory Testing | Proportion of individuals who test positive for influenza using the home-based influenza test compared to the number of individuals that test positive for influenza via a PCR laboratory test | Up to 48 hours | 
| Delivered Antivirals Within 48 Hours of Symptom Onset | Proportion of individuals who are delivered antivirals within 48 hours of symptom onset. Only drug eligible study participants prescribed an antiviral | Up to 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
influenza, flu, antiviral, baloxavir, Xofluza, rapid delivery, self-test