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

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT04141930
• Collaborator: Genentech, Inc. (Industry)
• Enrollment: 481
• Location: 1
• Arm: 1
• Actual Duration (Months): 5
• Patients Per Site Per Month: 96.3

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Nov 1, 2019
• Actual Primary Completion Date: Apr 1, 2020
• Actual Study Completion Date: Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 Names: Xofluza

Outcome Measures

Primary Outcome Measures

1. Initiate Antiviral Therapy Within 48 Hours of Symptom Onset [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington	Seattle	Washington	United States	98109

Sponsors and Collaborators

• University of Washington
• Genentech, Inc.

Investigators

• Principal Investigator: Helen Y Chu, MD, MPH, University of Washington

Study Documents (Full-Text)

• Study Protocol - Jan 14, 2021
• Statistical Analysis Plan - Oct 8, 2019

More Information

Publications

• 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.
• 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. Epub 2004 Jan 26.
• 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.
• 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.
• 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.
• 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.

• 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: Oct 28, 2019
• Last Update Posted: Aug 5, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Assistant Professor, School of Medicine: Allergy and Infectious Diseases, University of Washington: influenza; flu; antiviral; baloxavir; Xofluza; rapid delivery; self-test
• Additional relevant MeSH terms: Influenza, Human; Virus Diseases; Baloxavir

Study Results

Participant Flow

Arm/Group Title	Study Drug Eligible	Study Drug Ineligible
Arm/Group Description	Baloxavir given in 40 mg and 80 mg tablets for single-dose oral consumption during the first influenza infection for that participant. Individuals need to be eligible based on on-label use according to their age and medical history. Baloxavir Marboxil: Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset	Individuals not eligible to receive on-label use of Baloxavir due to age or medical history
Period Title: Overall Study
STARTED	302	179
COMPLETED	302	179
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Study Drug Eligible
Arm/Group Description	Baloxavir given in 40 mg and 80 mg tablets for single-dose oral consumption during the first influenza infection for that participant Baloxavir Marboxil: Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset
Overall Participants	481
Age (Count of Participants)
<=18 years	221 45.9%
Between 18 and 65 years	250 52%
>=65 years	10 2.1%
Sex: Female, Male (Count of Participants)
Female	253 52.6%
Male	228 47.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	35 7.3%
Not Hispanic or Latino	439 91.3%
Unknown or Not Reported	7 1.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	9 1.9%
Native Hawaiian or Other Pacific Islander	2 0.4%
Black or African American	8 1.7%
White	408 84.8%
More than one race	31 6.4%
Unknown or Not Reported	23 4.8%
Region of Enrollment (participants) [Number]
United States	481 100%

Outcome Measures

1. Primary Outcome

Title	Initiate Antiviral Therapy Within 48 Hours of Symptom Onset
Description	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.
Time Frame	Up to 48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study Drug Eligible
Arm/Group Description	Baloxavir given in 40 mg and 80 mg tablets for single-dose oral consumption during the first influenza infection for that participant Baloxavir Marboxil: Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset
Measure Participants	8
Count of Participants [Participants]	8 1.7%

2. Secondary Outcome

Title	Home Influenza Tests Confirmed by Laboratory Testing
Description	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
Time Frame	Up to 48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study Drug Eligible
Arm/Group Description	Baloxavir given in 40 mg and 80 mg tablets for single-dose oral consumption during the first influenza infection for that participant Baloxavir Marboxil: Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset
Measure Participants	12
Count of Participants [Participants]	8 1.7%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study Drug Eligible
Arm/Group Description	Baloxavir given in 40 mg and 80 mg tablets for single-dose oral consumption during the first influenza infection for that participant Baloxavir Marboxil: Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset
Measure Participants	8
Count of Participants [Participants]	8 1.7%

Adverse Events

Time Frame	14 days after receipt of antiviral
Arm/Group Title	Study Drug Eligible
Arm/Group Description	Baloxavir given in 40 mg and 80 mg tablets for single-dose oral consumption during the first influenza infection for that participant Baloxavir Marboxil: Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset
All Cause Mortality
	Study Drug Eligible
	Affected / at Risk (%)	# Events
Total	0/302 (0%)
Serious Adverse Events
	Study Drug Eligible
	Affected / at Risk (%)	# Events
Total	1/302 (0.3%)
Respiratory, thoracic and mediastinal disorders
Respiratory failure	1/302 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Study Drug Eligible
	Affected / at Risk (%)	# Events
Total	5/302 (1.7%)
Gastrointestinal disorders
Diarrhea	3/302 (1%)	3
Infections and infestations
Headache	2/302 (0.7%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.