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

NCT04141930 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: STUDY00008200
• Study Type: interventional
• Target: 481
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza; Respiratory Viral Infection

Keywords

influenza; flu; antiviral; baloxavir; Xofluza; rapid delivery; self-test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Home Influenza Tests Confirmed by Laboratory Testing

  Up to 48 hours

• Delivered Antivirals Within 48 Hours of Symptom Onset

  Up to 48 hours

Study Arms (1)

Study Drug Eligible

OTHER

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

Interventions

Baloxavir Marboxil DRUG

Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset

Also known as: Xofluza

Study Drug Eligible

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Household Level:

Sponsors & Collaborators

• University of Washington: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98109, United States

Location

Related Publications (7)

• Hayden FG, Sugaya N, Hirotsu N, Lee N, de Jong MD, Hurt AC, Ishida T, Sekino H, Yamada K, Portsmouth S, Kawaguchi K, Shishido T, Arai M, Tsuchiya K, Uehara T, Watanabe A; Baloxavir Marboxil Investigators Group. Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents. N Engl J Med. 2018 Sep 6;379(10):913-923. doi: 10.1056/NEJMoa1716197.

  PMID: 30184455 BACKGROUND

• Hayden FG, Belshe R, Villanueva C, Lanno R, Hughes C, Small I, Dutkowski R, Ward P, Carr J. Management of influenza in households: a prospective, randomized comparison of oseltamivir treatment with or without postexposure prophylaxis. J Infect Dis. 2004 Feb 1;189(3):440-9. doi: 10.1086/381128. Epub 2004 Jan 26.

  PMID: 14745701 BACKGROUND

• Welliver R, Monto AS, Carewicz O, Schatteman E, Hassman M, Hedrick J, Jackson HC, Huson L, Ward P, Oxford JS; Oseltamivir Post Exposure Prophylaxis Investigator Group. Effectiveness of oseltamivir in preventing influenza in household contacts: a randomized controlled trial. JAMA. 2001 Feb 14;285(6):748-54. doi: 10.1001/jama.285.6.748.

  PMID: 11176912 BACKGROUND

• Leung YH, Li MP, Chuang SK. A school outbreak of pandemic (H1N1) 2009 infection: assessment of secondary household transmission and the protective role of oseltamivir. Epidemiol Infect. 2011 Jan;139(1):41-4. doi: 10.1017/S0950268810001445. Epub 2010 Jun 21.

  PMID: 20561390 BACKGROUND

• Fry AM, Goswami D, Nahar K, Sharmin AT, Rahman M, Gubareva L, Azim T, Bresee J, Luby SP, Brooks WA. Efficacy of oseltamivir treatment started within 5 days of symptom onset to reduce influenza illness duration and virus shedding in an urban setting in Bangladesh: a randomised placebo-controlled trial. Lancet Infect Dis. 2014 Feb;14(2):109-18. doi: 10.1016/S1473-3099(13)70267-6. Epub 2013 Nov 22.

  PMID: 24268590 BACKGROUND

• Takashita E, Ichikawa M, Morita H, Ogawa R, Fujisaki S, Shirakura M, Miura H, Nakamura K, Kishida N, Kuwahara T, Sugawara H, Sato A, Akimoto M, Mitamura K, Abe T, Yamazaki M, Watanabe S, Hasegawa H, Odagiri T. Human-to-Human Transmission of Influenza A(H3N2) Virus with Reduced Susceptibility to Baloxavir, Japan, February 2019. Emerg Infect Dis. 2019 Nov;25(11):2108-2111. doi: 10.3201/eid2511.190757. Epub 2019 Nov 17.

  PMID: 31436527 BACKGROUND

• Emanuels A, Casto AM, Heimonen J, O'Hanlon J, Chow EJ, Ogokeh C, Rolfes MA, Han PD, Hughes JP, Uyeki TM, Frazar C, Chung E, Starita LM, Englund JA, Chu HY; Seattle Flu Study Investigators. Remote surveillance and detection of SARS-CoV-2 transmission among household members in King County, Washington. BMC Infect Dis. 2024 Mar 13;24(1):309. doi: 10.1186/s12879-024-09160-z.

  PMID: 38481147 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

baloxavir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Research Coordinator
• Organization: University of Washington

jheimo@uw.edu

2066165859

Study Officials

• Helen Y Chu, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine: Allergy and Infectious Diseases

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 28, 2019
• Study Start: November 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: August 5, 2021
• Results First Posted: August 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)