Xofluza-Wearables Feasibility-Study

July 9, 2025 updated by: Children's Hospital of Philadelphia

A Feasibility Study of Xofluza Treatment of Influenza in Pediatric Transplant Recipients, Waitlisted Subjects and Household Members After Early Infection Alerting Using Wearable Devices

The goal of this prospective, interventional, single-center study is to assess whether the early detection of Influenza with smart wearable device algorithms and alerting, rapid testing, and subsequent Baloxavir treatment demonstrate better post-infection outcomes versus publicly available- and Centers for Disease Control (CDC)-derived national statistics for equivalent household populations as well as pediatric kidney, heart, liver, lung transplant recipients and waitlisted patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Influenza infections are a significant concern for the clinical management of transplant recipients, a highly vulnerable immunocompromised patient group. Early Influenza detection has major benefits for the successful treatment in that crucial early infection time window and allows for more timely mitigation measures to be employed. Xofluza® (Baloxavir Marboxil), FDA approved in 2018 for the treatment of acute Influenza, has been shown to have improved outcome characteristics versus Tamiflu® (Oseltamivir), as well as compliance (a single pill given once, versus 10 pills taken over 5 days for Oseltamivir). The timing of the influenza diagnoses and intervention greatly impacts the outcomes in both antiviral medications though. Smart wearable devices have demonstrated clear utility to detect early infection using physiological signatures such as sub-symptomatic increases in heart rate (HR) and body temperature. Detection of Influenza and severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) have been shown to be robustly detectable several days prior to clinical symptoms onset in large well-powered smartwatch studies.

This is a sub-study of the existing Institutional Review Board (IRB) # 20-017872 protocol: "Early Detection of SARS-CoV-2 & other Infections using Wearable Devices in Pediatric Transplant Patients and Household Members". This is a prospective, interventional, single-center study at The Children's Hospital of Philadelphia comprising kidney, heart, liver and lung transplant recipients, waitlisted patients, and their household members. Subjects will wear smart wearable devices to monitor biometrics including HR, HR variation (HRV) and proxies of body temperature. A smart wearable device alert generated from a validated early infection detection algorithm and alerting platform, precipitates subjects to use an at-home collection kit for SARS-CoV-2, Influenza A/B and respiratory syncytial virus (RSV) A/B which is then sent to a central clinical lab for polymerase chain reaction (PCR)-based diagnoses. If the transplant recipient is positive for Influenza A/B the local clinical care team will be informed to determine if Baloxavir and/or any other medication is warranted. Genentech will make the Baloxavir medication available via the CHOP transplant pharmacist through the recipients' regular pharmacy. If the non-transplanted household members are positive for Influenza or exposed to Influenza positive infected subject(s) their treatment will be determined by their own primary-care. All CHOP transplant recipients will have their medical records reviewed for relevant covariates and confounders after Baloxavir treatment. Study subjects will complete short daily REDCap symptom forms for the pre-, peri- and post-infection periods.

Study Type

Interventional

Enrollment (Actual)

498

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19014
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

Population 1: Potential Baloxavir treatment group (CHOP transplant subjects 5 years & up)

  • Willing CHOP male or female kidney, heart, liver or lung single or multiple transplant recipients aged 5 years or older as per FDA guidelines.
  • Willing to regularly wear a smartwatch and take an at-home positive respiratory virus (RV) panel which will include a diagnoses of Influenza A or B.
  • Have an antigen positive diagnoses of Influenza A or B (a PCR-based positive clinical diagnoses of Influenza A or B may be requested in "alarm positive plus antigen positive but asymptomatic" cases).
  • Can be included if their treating physician prescribe prophylactic treatment of Baloxavir if the subject has been exposed to Influenza.
  • If Baloxavir is prescribed the study subject should be treated within 48 hours of symptom onset (regardless of the alarming time).

Population 2: Potential Baloxavir treatment group (CHOP waitlisted subjects 5 years & up)

• Willing waitlisted CHOP kidney, heart, liver or lung single or multiple transplant recipients aged 5 years or older, which are anticipated to have a transplant in the next 12 months.

Population 3: Potential Baloxavir treatment group (non-transplanted household members)

  • Non-transplanted household member of a CHOP transplant recipient or waitlisted patient
  • Be at least 5 years of age.
  • Willing to regularly wear a smartwatch and take an at-home positive respiratory virus (RV) panel for diagnoses of Influenza A or B.
  • Have a Antigen-based positive diagnoses of Influenza A or B

Population 4: Non-Baloxavir treatment subjects

  • CHOP transplant recipients and all other non-transplanted household members who are 2-4 years of age.
  • Subjects 5 years and up who are Influenza positive but whom do not receive Baloxavir treatment

Exclusion Criteria

Population 1:

  • Any allergy to Baloxavir (although they can remain in the study as an influenza case or control without Baloxavir treatment, or if they have been treated with a different medication for influenza) or a recommendation from the study physicians'/transplant pharmacist(s) not to take Baloxavir.
  • Subjects weighing < 20 kg
  • If the subject is unable or unwilling to consent.
  • If the subject is younger than 5 years of age.
  • If the subject requires mechanical ventilation at time of enrollment.
  • If the subject is pregnant or breast feeding at the time of early infection alerting.
  • If the subject is taking a prohibited medication. These include Influenza antiviral drugs with the exception of oseltamivir and baloxavir (such as peramivir, laninamivir, zanamivir, rimantadine, umifenovir or amantadine).
  • Unwilling or unable to comply with the study requirements.

Population 2: All exclusion criteria listed for Population 1

Population 3:

  • Subjects weighing < 20 kg
  • A household transplant recipient is not participating in the study
  • Any allergy to Baloxavir (although they will remain in the study as an influenza case/control without treatment)
  • A recommendation from the study physicians'/transplant pharmacist not to take Baloxavir
  • If the subject is unable or unwilling to consent.
  • If the subject is younger than 5 years of age.
  • If the subject is pregnant at screening.
  • If the subject is taking a prohibited medication. These include Influenza antiviral drugs with the exception of oseltamivir and baloxavir (such as peramivir, laninamivir, zanamivir, rimantadine, umifenovir or amantadine).
  • Unwilling or unable to comply with the study requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Population 1: Transplant Recipients
Participants who are a CHOP kidney, heart, liver or lung single or multiple transplant recipients aged 5 years or older will receive a single dose of Baloxavir.
Drug: Baloxavir Marboxil

Baloxavir marboxil will be administered as either a tablet or granules. Dose is based on body weight:

40 mg for a participants weighing 20-79 kg, or 80 mg for a patient weighing more than or equal to 80 kg

Other Names:
  • Xofluza
Experimental: Population 2: Waitlisted Patients for Transplant
Participants who are waitlisted CHOP kidney, heart, liver or lung single or multiple transplant recipients aged 5 years or older will receive a single dose of Baloxavir marboxil.
Drug: Baloxavir Marboxil

Baloxavir marboxil will be administered as either a tablet or granules. Dose is based on body weight:

40 mg for a participants weighing 20-79 kg, or 80 mg for a patient weighing more than or equal to 80 kg

Other Names:
  • Xofluza
Experimental: Population 3: Household Members (Non-Transplant)
Non-Transplanted Household Members aged 5 years or older will receive a single dose of Baloxavir marboxil.
Drug: Baloxavir Marboxil

Baloxavir marboxil will be administered as either a tablet or granules. Dose is based on body weight:

40 mg for a participants weighing 20-79 kg, or 80 mg for a patient weighing more than or equal to 80 kg

Other Names:
  • Xofluza
No Intervention: Population 4: Non-Baloxavir treatment subjects

CHOP transplant recipients and all other non-transplanted household members who are 2-4 years of age.

Subjects 5 years and up who are Influenza positive but whom do not receive Baloxavir treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-to-Clinical-Response
Time Frame: 30 days post-Baloxavir treatment
For subjects infected with Influenza investigators will assess Time-to-Clinical-Response in a time frame up to 30 days post Baloxavir treatment in this study vs comparable data available from national control groups. Time to Clinical Response is based on: (a) temperature ranges as measured by (standard of care and/or smartwatch biometric data), oxygen saturation, respiratory status, HR, and hospitalization status; (b) return to healthy baseline data including from biometric data derived from the subjects' smartwatch; (c) time to symptom resolution in a time frame up to 30 days post Baloxavir treatment as assessed from a return to healthy baseline on the daily questionnaires).
30 days post-Baloxavir treatment
Incidence of complicated hospital stay(s)
Time Frame: 30 days post-Baloxavir treatment
Incidence of complicated hospital stay(s) for a time frame up to 30 days post Baloxavir treatment in this study versus comparable data available from the previously described national control groups. A complicated hospital stay is defined as a hospital admission that was either prolonged (greater than 7 days), requiring ICU level of care or death at day 30 as a result of influenza infection.
30 days post-Baloxavir treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Respiratory Tract Infection Progression Following Treatment
Time Frame: 30 days post-Baloxavir treatment
Progression to lower respiratory tract infections in a time frame up to 30 days post Baloxavir treatment in this study versus comparable data available from national control groups.
30 days post-Baloxavir treatment
Length of hospital Stay Following Treatment
Time Frame: 30 days post-Baloxavir treatment
Length of hospital stay in a time frame up to 30 days post Baloxavir treatment in our study versus comparable data available from national control groups.
30 days post-Baloxavir treatment
Oxygen requirement Following Treatment
Time Frame: 30 days post-Baloxavir treatment
Oxygen requirement in a time frame up to 30 days post Baloxavir treatment in this study versus comparable data available from national control groups.
30 days post-Baloxavir treatment
Rate of Respiratory Failure Following Treatment
Time Frame: 30 days post-Baloxavir treatment
Rate of respiratory failure in a time frame up to 30 days post Baloxavir treatment in this study versus comparable data available from national control groups.
30 days post-Baloxavir treatment
30-day Mortality Rate Following Treatment
Time Frame: 30 days post-Baloxavir treatment
30-day mortality for post Baloxavir treatment in this study versus comparable data available from national control groups.
30 days post-Baloxavir treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Matthew O Connor, MD, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2023

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Actual)

December 8, 2023

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-020440

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Summary-level statistics and outcomes of primary and secondary study endpoints will be made available to any study publications.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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