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Status:

COMPLETED

Xofluza-Wearables Feasibility-Study

Lead Sponsor:

Children's Hospital of Philadelphia

Collaborating Sponsors:

Genentech, Inc.

Conditions:

Infection, Coronavirus

Infections

Eligibility:

All Genders

2+ years

Phase:

PHASE4

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 subsequen...

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 f...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    December 14 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 30 2025

    Estimated Enrollment :

    498 Patients enrolled

    Trial Details

    Trial ID

    NCT06161454

    Start Date

    December 14 2023

    End Date

    April 30 2025

    Last Update

    July 11 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States, 19014