Using smart wearables to detect and treat influenza in transplant patients

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.