Xofluza-Wearables Feasibility-Study

• Status: Recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this prospective, interventional, single-center study is to assess whether the early detection of Influenza with smartwatch 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Collaborator: Genentech, Inc.
• Treatments: Baloxavir

Criteria

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.

• All other inclusion criteria listed in 3.3.1.

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 < 40 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 < 40 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.