Infection, CoronavirusPhase 4NCT06161454
Xofluza-Wearables Feasibility-Study
A Phase 4 study testing Baloxavir Marboxil in people with Infection, Coronavirus and Infections, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection, Coronavirus, Infections, Influenza
- What is being tested?
- Baloxavir Marboxil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2023to 30 Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19014
About this study
Official title: 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.
Read the 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.
- Conditions
- Infection, Coronavirus, Infections, Influenza, Transplant, Infection Viral
- Being tested
- Baloxavir Marboxil
- Keywords
- Transplant, Infections, Wearable Devices, smart wearable device, Xofluza, Influenza
- Medical subject headings
- Coronavirus Infections, Infections, Influenza, Human, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baloxavir MarboxilDrug
Also called Xofluza
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 30 days post-Baloxavir treatment
Secondary outcomes (5)
Incidence of Respiratory Tract Infection Progression Following 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.
Measured: 30 days post-Baloxavir treatment
Length of hospital Stay Following 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.
Measured: 30 days post-Baloxavir treatment
Oxygen requirement Following 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.
Measured: 30 days post-Baloxavir treatment
Rate of Respiratory Failure Following 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.
Measured: 30 days post-Baloxavir treatment
30-day Mortality Rate Following Treatment
30-day mortality for post Baloxavir treatment in this study versus comparable data available from national control groups.
Measured: 30 days post-Baloxavir treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start14 Dec 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Infection, CoronavirusStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Matthew O Connor, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161454
- Sponsor's protocol ID
- 22-020440
- Status last verified
- Jul 2025
- First submitted
- 27 Nov 2023
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Summary-level statistics and outcomes of primary and secondary study endpoints will be made available to any study publications.
Publications
Baxter D. Evaluating the case for trivalent or quadrivalent influenza vaccines. Hum Vaccin Immunother. 2016 Oct 2;12(10):2712-2717. doi: 10.1080/21645515.2015.1091130. Epub 2016 Jul 19.
PubMed 27435025Vanderlinden E, Naesens L. Emerging antiviral strategies to interfere with influenza virus entry. Med Res Rev. 2014 Mar;34(2):301-39. doi: 10.1002/med.21289. Epub 2013 Jun 25.
PubMed 23801557Tsang TK, Lau LLH, Cauchemez S, Cowling BJ. Household Transmission of Influenza Virus. Trends Microbiol. 2016 Feb;24(2):123-133. doi: 10.1016/j.tim.2015.10.012. Epub 2015 Nov 21.
PubMed 26612500Paules C, Subbarao K. Influenza. Lancet. 2017 Aug 12;390(10095):697-708. doi: 10.1016/S0140-6736(17)30129-0. Epub 2017 Mar 13.
PubMed 28302313Lee N, Ison MG. Diagnosis, management and outcomes of adults hospitalized with influenza. Antivir Ther. 2012;17(1 Pt B):143-57. doi: 10.3851/IMP2059. Epub 2012 Feb 3.
PubMed 22311561Kumar D, Michaels MG, Morris MI, Green M, Avery RK, Liu C, Danziger-Isakov L, Stosor V, Estabrook M, Gantt S, Marr KA, Martin S, Silveira FP, Razonable RR, Allen UD, Levi ME, Lyon GM, Bell LE, Huprikar S, Patel G, Gregg KS, Pursell K, Helmersen D, Julian KG, Shiley K, Bono B, Dharnidharka VR, Alavi G, Kalpoe JS, Shoham S, Reid GE, Humar A; American Society of Transplantation H1N1 Collaborative Study Group. Outcomes from pandemic influenza A H1N1 infection in recipients of solid-organ transplants: a multicentre cohort study. Lancet Infect Dis. 2010 Aug;10(8):521-6. doi: 10.1016/S1473-3099(10)70133-X. Epub 2010 Jul 9.
PubMed 20620116Kumar D, Ferreira VH, Blumberg E, Silveira F, Cordero E, Perez-Romero P, Aydillo T, Danziger-Isakov L, Limaye AP, Carratala J, Munoz P, Montejo M, Lopez-Medrano F, Farinas MC, Gavalda J, Moreno A, Levi M, Fortun J, Torre-Cisneros J, Englund JA, Natori Y, Husain S, Reid G, Sharma TS, Humar A. A 5-Year Prospective Multicenter Evaluation of Influenza Infection in Transplant Recipients. Clin Infect Dis. 2018 Oct 15;67(9):1322-1329. doi: 10.1093/cid/ciy294.
PubMed 29635437Noshi T, Kitano M, Taniguchi K, Yamamoto A, Omoto S, Baba K, Hashimoto T, Ishida K, Kushima Y, Hattori K, Kawai M, Yoshida R, Kobayashi M, Yoshinaga T, Sato A, Okamatsu M, Sakoda Y, Kida H, Shishido T, Naito A. In vitro characterization of baloxavir acid, a first-in-class cap-dependent endonuclease inhibitor of the influenza virus polymerase PA subunit. Antiviral Res. 2018 Dec;160:109-117. doi: 10.1016/j.antiviral.2018.10.008. Epub 2018 Oct 11.
PubMed 30316915O'Hanlon R, Shaw ML. Baloxavir marboxil: the new influenza drug on the market. Curr Opin Virol. 2019 Apr;35:14-18. doi: 10.1016/j.coviro.2019.01.006. Epub 2019 Mar 8.
PubMed 30852344Watanabe A, Ishida T, Hirotsu N, Kawaguchi K, Ishibashi T, Shishido T, Sato C, Portsmouth S, Tsuchiya K, Uehara T. Baloxavir marboxil in Japanese patients with seasonal influenza: Dose response and virus type/subtype outcomes from a randomized phase 2 study. Antiviral Res. 2019 Mar;163:75-81. doi: 10.1016/j.antiviral.2019.01.012. Epub 2019 Jan 23.
PubMed 30684563Hayden FG, Sugaya N, Hirotsu N, Lee N, de Jong MD, Hurt AC, Ishida T, Sekino H, Yamada K, Portsmouth S, Kawaguchi K, Shishido T, Arai M, Tsuchiya K, Uehara T, Watanabe A; Baloxavir Marboxil Investigators Group. Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents. N Engl J Med. 2018 Sep 6;379(10):913-923. doi: 10.1056/NEJMoa1716197.
PubMed 30184455Ison MG, Portsmouth S, Yoshida Y, Shishido T, Mitchener M, Tsuchiya K, Uehara T, Hayden FG. Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2): a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2020 Oct;20(10):1204-1214. doi: 10.1016/S1473-3099(20)30004-9. Epub 2020 Jun 8.
PubMed 32526195Baker J, Block SL, Matharu B, Burleigh Macutkiewicz L, Wildum S, Dimonaco S, Collinson N, Clinch B, Piedra PA. Baloxavir Marboxil Single-dose Treatment in Influenza-infected Children: A Randomized, Double-blind, Active Controlled Phase 3 Safety and Efficacy Trial (miniSTONE-2). Pediatr Infect Dis J. 2020 Aug;39(8):700-705. doi: 10.1097/INF.0000000000002747.
PubMed 32516282Ikematsu H, Hayden FG, Kawaguchi K, Kinoshita M, de Jong MD, Lee N, Takashima S, Noshi T, Tsuchiya K, Uehara T. Baloxavir Marboxil for Prophylaxis against Influenza in Household Contacts. N Engl J Med. 2020 Jul 23;383(4):309-320. doi: 10.1056/NEJMoa1915341. Epub 2020 Jul 8.
PubMed 32640124Umemura T, Mutoh Y, Kawamura T, Saito M, Mizuno T, Ota A, Kozaki K, Yamada T, Ikeda Y, Ichihara T. Efficacy of baloxavir marboxil on household transmission of influenza infection. J Pharm Health Care Sci. 2020 Oct 1;6:21. doi: 10.1186/s40780-020-00178-4. eCollection 2020.
PubMed 33014405
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Xofluza Treatment of Influenza in Pediatric Transplant Recipients, Waitlisted Subjects and Household Members After Early Infection Alerting Using Wearable Devices
- ClinicalTrials.gov ID
- NCT06161454
- Acronym / sponsor ID
- 22-020440
- Conditions
- Infection, Coronavirus, Infections, Influenza, Transplant, Infection Viral
- Keywords
- Transplant, Infections, Wearable Devices, smart wearable device, Xofluza, Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Population 1: Transplant Recipients | Experimental | Drug: Baloxavir MarboxilParticipants 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. |
| Population 2: Waitlisted Patients for Transplant | Experimental | Drug: Baloxavir MarboxilParticipants 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. |
| Population 3: Household Members (Non-Transplant) | Experimental | Drug: Baloxavir MarboxilNon-Transplanted Household Members aged 5 years or older will receive a single dose of 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 |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baloxavir MarboxilAlso: XofluzaBaloxavir 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 | Drug | Population 1: Transplant Recipients, Population 2: Waitlisted Patients for Transplant, Population 3: Household Members (Non-Transplant) |
Primary outcome
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).
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.
5 secondary outcomes
Incidence of Respiratory Tract Infection Progression Following Treatment
Time frame: 30 days post-Baloxavir treatment
Length of hospital Stay Following Treatment
Time frame: 30 days post-Baloxavir treatment
Oxygen requirement Following Treatment
Time frame: 30 days post-Baloxavir treatment
Rate of Respiratory Failure Following Treatment
Time frame: 30 days post-Baloxavir treatment
30-day Mortality Rate Following Treatment
Time frame: 30 days post-Baloxavir treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Background: PubMed 27435025Baxter D. Evaluating the case for trivalent or quadrivalent influenza vaccines. Hum Vaccin Immunother. 2016 Oct 2;12(10):2712-2717. doi: 10.1080/21645515.2015.1091130. Epub 2016 Jul 19.
- Background: PubMed 23801557Vanderlinden E, Naesens L. Emerging antiviral strategies to interfere with influenza virus entry. Med Res Rev. 2014 Mar;34(2):301-39. doi: 10.1002/med.21289. Epub 2013 Jun 25.
- Background: PubMed 26612500Tsang TK, Lau LLH, Cauchemez S, Cowling BJ. Household Transmission of Influenza Virus. Trends Microbiol. 2016 Feb;24(2):123-133. doi: 10.1016/j.tim.2015.10.012. Epub 2015 Nov 21.
- Background: PubMed 28302313Paules C, Subbarao K. Influenza. Lancet. 2017 Aug 12;390(10095):697-708. doi: 10.1016/S0140-6736(17)30129-0. Epub 2017 Mar 13.
- Background: PubMed 22311561Lee N, Ison MG. Diagnosis, management and outcomes of adults hospitalized with influenza. Antivir Ther. 2012;17(1 Pt B):143-57. doi: 10.3851/IMP2059. Epub 2012 Feb 3.
- Background: PubMed 20620116Kumar D, Michaels MG, Morris MI, Green M, Avery RK, Liu C, Danziger-Isakov L, Stosor V, Estabrook M, Gantt S, Marr KA, Martin S, Silveira FP, Razonable RR, Allen UD, Levi ME, Lyon GM, Bell LE, Huprikar S, Patel G, Gregg KS, Pursell K, Helmersen D, Julian KG, Shiley K, Bono B, Dharnidharka VR, Alavi G, Kalpoe JS, Shoham S, Reid GE, Humar A; American Society of Transplantation H1N1 Collaborative Study Group. Outcomes from pandemic influenza A H1N1 infection in recipients of solid-organ transplants: a multicentre cohort study. Lancet Infect Dis. 2010 Aug;10(8):521-6. doi: 10.1016/S1473-3099(10)70133-X. Epub 2010 Jul 9.
- Background: PubMed 29635437Kumar D, Ferreira VH, Blumberg E, Silveira F, Cordero E, Perez-Romero P, Aydillo T, Danziger-Isakov L, Limaye AP, Carratala J, Munoz P, Montejo M, Lopez-Medrano F, Farinas MC, Gavalda J, Moreno A, Levi M, Fortun J, Torre-Cisneros J, Englund JA, Natori Y, Husain S, Reid G, Sharma TS, Humar A. A 5-Year Prospective Multicenter Evaluation of Influenza Infection in Transplant Recipients. Clin Infect Dis. 2018 Oct 15;67(9):1322-1329. doi: 10.1093/cid/ciy294.
- Background: PubMed 30316915Noshi T, Kitano M, Taniguchi K, Yamamoto A, Omoto S, Baba K, Hashimoto T, Ishida K, Kushima Y, Hattori K, Kawai M, Yoshida R, Kobayashi M, Yoshinaga T, Sato A, Okamatsu M, Sakoda Y, Kida H, Shishido T, Naito A. In vitro characterization of baloxavir acid, a first-in-class cap-dependent endonuclease inhibitor of the influenza virus polymerase PA subunit. Antiviral Res. 2018 Dec;160:109-117. doi: 10.1016/j.antiviral.2018.10.008. Epub 2018 Oct 11.
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- Background: PubMed 30184455Hayden FG, Sugaya N, Hirotsu N, Lee N, de Jong MD, Hurt AC, Ishida T, Sekino H, Yamada K, Portsmouth S, Kawaguchi K, Shishido T, Arai M, Tsuchiya K, Uehara T, Watanabe A; Baloxavir Marboxil Investigators Group. Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents. N Engl J Med. 2018 Sep 6;379(10):913-923. doi: 10.1056/NEJMoa1716197.
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- Individual participant dataSharing planned: No. Summary-level statistics and outcomes of primary and secondary study endpoints will be made available to any study publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew O Connor, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Baloxavir Marboxil in people with Infection, Coronavirus and Infections, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-Clinical-Response (time frame: 30 days post-Baloxavir treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06161454, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.