NCT04141930

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 481 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 3 Months
• Healthy volunteers: Accepted

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.

Conditions

• Influenza
• Respiratory Viral Infection

Interventions

Type	Name	Description
DRUG	Baloxavir Marboxil	Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2019-10-28
• Last updated: 2021-08-05
• Results posted: 2021-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study