Xofluza-Wearables Feasibility-Study

NCT06161454 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 22-020440
• Study Type: interventional
• Target: 498
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infection, Coronavirus; Infections; Influenza; Transplant; Infection Viral

Keywords

Transplant; Infections; Wearable Devices; smart wearable device; Xofluza; Influenza

Outcome Measures

Primary Outcomes (2)

• Time-to-Clinical-Response

  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)

  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 Outcomes (5)

• Incidence of Respiratory Tract Infection Progression Following Treatment

  30 days post-Baloxavir treatment

• Length of hospital Stay Following Treatment

  30 days post-Baloxavir treatment

• Oxygen requirement Following Treatment

  30 days post-Baloxavir treatment

• Rate of Respiratory Failure Following Treatment

  30 days post-Baloxavir treatment

• 30-day Mortality Rate Following Treatment

  30 days post-Baloxavir treatment

Study Arms (4)

Population 1: Transplant Recipients

EXPERIMENTAL

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

Population 2: Waitlisted Patients for Transplant

EXPERIMENTAL

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

Population 3: Household Members (Non-Transplant)

EXPERIMENTAL

Non-Transplanted Household Members aged 5 years or older will receive a single dose of Baloxavir marboxil.

Drug: Baloxavir Marboxil

Population 4: Non-Baloxavir treatment subjects

NO INTERVENTION

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

Interventions

Baloxavir Marboxil DRUG

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

Also known as: Xofluza

Population 1: Transplant Recipients; Population 2: Waitlisted Patients for Transplant; Population 3: Household Members (Non-Transplant)

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19014, United States

Location

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MeSH Terms

Conditions

Coronavirus Infections; Infections; Influenza, Human; Virus Diseases

Interventions

baloxavir

Condition Hierarchy (Ancestors)

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

Study Officials

• Matthew O Connor, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 8, 2023
• Study Start: December 14, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)