InfluenzaPhase 4pCHIMESNCT04141930

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

A Phase 4 study testing Baloxavir Marboxil in people with Influenza and Respiratory Viral Infection, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 3 months and olderHealthy volunteers can take part
Conditions the study is for: Influenza, Respiratory Viral Infection
What is being tested?: Baloxavir Marboxil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 481 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2019to 1 Apr 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 months and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Show all 18Show fewer

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)

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington
Seattle, Washington, 98109

Other trials in United States

About this study

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

Read the 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
Being tested: Baloxavir Marboxil
Keywords: influenza, flu, antiviral, baloxavir, Xofluza, rapid delivery, self-test
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04141930
Study group	Role	What they receive
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 Receives: Drug: Baloxavir Marboxil

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 48 hours

Secondary outcomes (2)

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
Measured: 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
Measured: Up to 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20191 Apr 2020

First posted28 Oct 2019
Study start1 Nov 2019
Primary completion1 Apr 2020
Study completion1 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 481 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04141930
Sponsor's protocol ID: STUDY00008200
Acronym: pCHIMES
Status last verified: Jul 2021
First submitted: 23 Oct 2019
Last updated: 5 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

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.
PubMed 30184455
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.
PubMed 14745701
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.
PubMed 11176912
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.
PubMed 20561390
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.
PubMed 24268590
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.
PubMed 31436527
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.
PubMed 38481147

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle (pCHIMES)
ClinicalTrials.gov ID: NCT04141930
Acronym / sponsor ID: pCHIMES / STUDY00008200
Conditions: Influenza, Respiratory Viral Infection
Keywords: influenza, flu, antiviral, baloxavir, Xofluza, rapid delivery, self-test
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 481 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: Genentech, Inc.
Study start: 1 Nov 2019 (actual)
Primary completion: 1 Apr 2020 (actual)
Study completion: 1 Apr 2020 (actual)
First posted: 28 Oct 2019 (actual)
Results: Posted 5 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study Drug Eligible	Other	Drug: Baloxavir MarboxilBaloxavir given in 40 mg and 80 mg tablets for single-dose oral consumption during the first influenza infection for that participant

Who may qualify

Ages: 3 months and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (18 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Baloxavir MarboxilAlso: XofluzaIndividuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset	Drug	Study Drug Eligible

Primary outcome

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.

2 secondary outcomes

Home Influenza Tests Confirmed by Laboratory Testing
Time frame: Up to 48 hours
Delivered Antivirals Within 48 Hours of Symptom Onset
Time frame: Up to 48 hours

Results and safety

Results posted to the registry on 5 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Drug Eligible	302	302
Study Drug Ineligible	179	179

Primary outcome: Initiate Antiviral Therapy Within 48 Hours of Symptom Onset

Time frame: Up to 48 hours. Count of participants. Unit: Participants

Measure	Study Drug Eligible n = 8
Value	8

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14 days after receipt of antiviral. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Drug Eligible	1 of 302 (0.3%)	5 of 302 (1.7%)	0 of 302

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30184455Hayden 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.
Background: PubMed 14745701Hayden 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.
Background: PubMed 11176912Welliver 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.
Background: PubMed 20561390Leung 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.
Background: PubMed 24268590Fry 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.
Background: PubMed 31436527Takashita 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.
Derived from this study: PubMed 38481147Emanuels 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.
Individual participant dataSharing planned: No. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Helen Y Chu, MD, MPH principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Baloxavir Marboxil in people with Influenza and Respiratory Viral Infection, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Initiate Antiviral Therapy Within 48 Hours of Symptom Onset (time frame: Up to 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04141930, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.