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Antiviral

Population 1: Transplant Recipients for Viral Infections

Phase 4

Recruiting

Led By Matthew O Connor, MD

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Population 1: If Baloxavir is prescribed, the study subject should be treated within 48 hours of symptom onset (regardless of the alarming time)

Population 1: Have an antigen positive diagnoses of Influenza A or B

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days post-baloxavir treatment

Awards & highlights

Study Summary

This trial aims to find out if using a smartwatch, rapid testing and Baloxavir treatment can help reduce Influenza after infection, esp. for at-risk populations.

Who is the study for?

This trial is for individuals aged 5 or older, including those who have had a transplant (kidney, heart, liver, lung) and their non-transplanted household members. Participants must be willing to wear a smartwatch and take an at-home test for Influenza A or B. Those with allergies to Baloxavir, under 40 kg in weight, pregnant or breastfeeding women, and anyone on mechanical ventilation are excluded.Check my eligibility

What is being tested?

The study tests if early detection of Influenza using smartwatches followed by rapid testing and treatment with Baloxavir can improve outcomes compared to national statistics. It includes pediatric transplant recipients/waitlisted patients at CHOP.See study design

What are the potential side effects?

While the side effects are not listed here explicitly for Baloxavir Marboxil (Xofluza), common ones include diarrhea, bronchitis symptoms like coughing and headaches; however individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I started taking Baloxavir within 48 hours after my symptoms began.

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I have been diagnosed with Influenza A or B.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days post-baloxavir treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days post-baloxavir treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post-baloxavir treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of complicated hospital stay(s)

Time-to-Clinical-Response

Secondary outcome measures

30-day Mortality Rate Following Treatment

Incidence of Respiratory Tract Infection Progression Following Treatment

Length of hospital Stay Following Treatment

+2 more

Side effects data

From 2020 Phase 4 trial • 481 Patients • NCT04141930

Diarrhea

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Study Drug Eligible

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Population 3: Household Members (Non-Transplant)Experimental Treatment1 Intervention

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

Group II: Population 2: Waitlisted Patients for TransplantExperimental Treatment1 Intervention

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.

Group III: Population 1: Transplant RecipientsExperimental Treatment1 Intervention

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.

Group IV: Population 4: Non-Baloxavir treatment subjectsActive Control1 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Baloxavir Marboxil

2019

Completed Phase 4

~4720

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,582,280 Total Patients Enrolled

2 Trials studying Viral Infections

210 Patients Enrolled for Viral Infections

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

567,603 Total Patients Enrolled

Matthew O Connor, MDPrincipal InvestigatorChildren's Hospital of Philadelphia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment recruiting participants at present?

"Affirmative, based on the information available on clinicaltrials.gov this trial is currently recruiting participants. This research study was first listed on December 1st 2023 and has since been updated as recently as November 27th 2023. 540 patients are being sought out at one medical facility for enrolment in this trial."

Answered by AI

Has the FDA sanctioned Population 1: Transplant Recipients?

"After carefully reviewing the evidence, our team rated Population 1: Transplant Recipients a 3 as this is a Phase 4 trial and thus approved for use."

Answered by AI

How many participants are currently receiving treatment in this clinical research study?

"Affirmative. Clinicaltrials.gov attests that this clinical trial is currently enrolling patients, with the initial posting occuring on December 1st 2023 and the last update occurring on November 27th 2023. The study requires 540 individuals to be recruited from a single location."

Answered by AI

What are the outcomes that researchers hope to achieve with this study?

"The primary evaluation criterion of this trial, to be measure over a 30 day period post-Baloxavir treatment, is the Time-to-Clinical-Response. Secondary endpoints include Oxygen requirement compared with national control groups; mortality rate related to Baloxavir therapy within thirty days; and Progression into lower respiratory tract infections measured against existing data from external sources."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents

Hayden, Frederick G., Norio Sugaya, Nobuo Hirotsu, Nelson Lee, Menno D. de Jong, Aeron C. Hurt, Tadashi Ishida, et al.. 2018. “Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1716197.

clinicaltrials.govStudy

Xofluza-Wearables Feasibility-Study

2023. "Xofluza-Wearables Feasibility-Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06161454.

All > Infectious Disease > Xofluza