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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04141930
Recruitment Status : Completed
First Posted : October 28, 2019
Results First Posted : August 5, 2021
Last Update Posted : August 5, 2021
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Helen Chu, University of Washington

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.

Condition or disease Intervention/treatment Phase
Influenza Respiratory Viral Infection Drug: Baloxavir Marboxil Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 481 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle (pCHIMES)
Actual Study Start Date : November 1, 2019
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Study Drug Eligible
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
Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset
Other Name: Xofluza




Primary Outcome Measures :
  1. Initiate Antiviral Therapy Within 48 Hours of Symptom Onset [ Time Frame: Up to 48 hours ]
    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.


Secondary Outcome Measures :
  1. Home Influenza Tests Confirmed by Laboratory Testing [ Time Frame: Up to 48 hours ]
    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

  2. Delivered Antivirals Within 48 Hours of Symptom Onset [ Time Frame: Up to 48 hours ]
    Proportion of individuals who are delivered antivirals within 48 hours of symptom onset. Only drug eligible study participants prescribed an antiviral



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04141930


Locations
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United States, Washington
University of Washington
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
Genentech, Inc.
Investigators
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Principal Investigator: Helen Y Chu, MD, MPH University of Washington
  Study Documents (Full-Text)

Documents provided by Helen Chu, University of Washington:
Study Protocol  [PDF] January 14, 2021
Statistical Analysis Plan  [PDF] October 8, 2019

Publications:

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Responsible Party: Helen Chu, Assistant Professor, School of Medicine: Allergy and Infectious Diseases, University of Washington
ClinicalTrials.gov Identifier: NCT04141930    
Other Study ID Numbers: STUDY00008200
First Posted: October 28, 2019    Key Record Dates
Results First Posted: August 5, 2021
Last Update Posted: August 5, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

We do not currently expect to share specimens with outside investigators, but if compelling opportunities arise that will advance the overall objectives of this research, the Executive Committee of the study will consider such requests. They alone have the authority to make such decisions.

All biospecimens (nasal swabs) will be coded and identifiable through the study's main database. Any specimens shared with external investigators (if deemed appropriate by the Executive Committee) will have identifiers removed prior to sharing.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Helen Chu, University of Washington:
influenza
flu
antiviral
baloxavir
Xofluza
rapid delivery
self-test
Additional relevant MeSH terms:
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Influenza, Human
Virus Diseases
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Baloxavir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action