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Antiviral

Xofluza for Flu

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

Must not have

Population 1: Subjects weighing < 40 kg

Population 1: If the subject is younger than 5 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days post-baloxavir treatment

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I weigh less than 40 kg.

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I am younger than 5 years old.

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I weigh less than 40 kg.

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I am younger than 5 years old.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of complicated hospital stay(s)

Time-to-Clinical-Response

Secondary study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~8900

0 / 6Eligibility criteria met