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Antiviral

Baloxavir Marboxil for Flu

Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of (a) fever (>=38.0 °C per tympanic or rectal thermometer; >=37.5 °C per axillary, oral or forehead/temporal thermometer) or (b) any influenza symptoms (cough, sore throat, nasal congestion, headache, feverishness or chills, muscle or joint pain, fatigue).
Index Patients (IPs) must have presence of (a) fever (>=38.0 °C per tympanic or rectal thermometer; >=37.5 °C per axillary, oral or forehead/temporal thermometer) or (b) any influenza symptoms (cough, sore throat, nasal congestion, headache, feverishness or chills, muscle or joint pain, fatigue) with a time interval between the onset of fever or influenza symptoms and the pre-dose examinations of 48 hours or less
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 9 (9 days)
Awards & highlights

Study Summary

This trial is testing the efficacy of baloxavir marboxil in reducing the spread of influenza within households.

Who is the study for?
This trial is for people with recent onset flu symptoms who live with others not vaccinated against the flu in the last 6 months. Participants must be healthy otherwise, able to follow study rules, and test negative for COVID-19. Pregnant women, breastfeeding mothers, those allergic to Baloxavir Marboxil or its ingredients, and anyone treated recently with certain antiviral drugs can't join.Check my eligibility
What is being tested?
The study tests if Baloxavir Marboxil can prevent spreading the flu within households compared to a placebo. Healthy individuals showing flu symptoms are chosen randomly to receive either the medication or a placebo. Their household contacts are monitored for signs of catching the flu.See study design
What are the potential side effects?
Baloxavir Marboxil may cause side effects like diarrhea, bronchitis, nausea, sinusitis and headache. However, since this trial includes a placebo group as well, some participants might not experience any real medication-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a fever or symptoms like a cough, sore throat, and headache.
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I have had a fever or flu symptoms for 2 days or less.
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I have a fever or symptoms like a flu.
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I tested positive for influenza A/B using a PCR or rapid test.
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I have been diagnosed with the flu by a doctor.
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I live with someone who tested negative for flu and we meet the vaccine and living arrangement criteria.
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I agree to follow the study's rules for preventing pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 9 (for ips ≥12 years old) and day 21 (for ips <12 years old)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 9 (for ips ≥12 years old) and day 21 (for ips <12 years old) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Virological Transmission by Day 5
Secondary outcome measures
Any Symptomatic Infection at the Household Level by Day 9
Any Symptomatic Infection by Day 9
Any Virological Infection at the Household Level by Day 9
+8 more

Side effects data

From 2020 Phase 4 trial • 481 Patients • NCT04141930
1%
Diarrhea
1%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Study Drug Eligible

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Baloxavir MarboxilExperimental Treatment1 Intervention
Participants who are IPs will receive a single oral dose of baloxavir marboxil. HHCs of the IPs will not receive study medication.
Group II: PlaceboPlacebo Group1 Intervention
Participants who are IPs will receive a single oral dose of placebo. HHCs of the IPs will not receive study medication.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baloxavir Marboxil
2019
Completed Phase 4
~4720

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,427 Previous Clinical Trials
1,085,991 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
885,419 Total Patients Enrolled

Media Library

Baloxavir Marboxil (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT03969212 — Phase 3
Influenza Research Study Groups: Baloxavir Marboxil, Placebo
Influenza Clinical Trial 2023: Baloxavir Marboxil Highlights & Side Effects. Trial Name: NCT03969212 — Phase 3
Baloxavir Marboxil (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03969212 — Phase 3
Influenza Patient Testimony for trial: Trial Name: NCT03969212 — Phase 3

Frequently Asked Questions

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

Could you please give an estimate of how many people are being used as test subjects in this experiment?

"Yes, that is accurate. The listing on clinicaltrials.gov shows that this study began recruiting patients on October 10th, 2019 and is still ongoing. Currently, 3160 individuals are needed from a total of 41 sites."

Answered by AI

Is this research the first to study this topic?

"Baloxavir Marboxil is being studied in 4 active clinical trials taking place in 91 cities and 26 countries. The first trial began in 2019 and was sponsored by Hoffmann-La Roche. Only 30 patients were needed for the Phase 3 drug approval stage. Since then, 18294 studies have been completed."

Answered by AI

Are people still being signed up for this experiment?

"You're correct, the trial is recruiting patients right now. The listing on clinicaltrials.gov shows that the trial was posted on October 10th, 2019 and last updated October 27th, 2020."

Answered by AI

Is this research being conducted with middle-aged adults?

"This trial's inclusion criteria includes a minimum age of 5 and a maximum age of 64."

Answered by AI

How can I sign up to participate in this research project?

"Eligible individuals for this study are those that have influenza, are human, and between the ages of 5-64. A total of 3160 people are required for the study."

Answered by AI

Are there any potential dangers in taking Baloxavir Marboxil?

"Baloxavir Marboxil is Phase 3, meaning that while there is data supporting efficacy, multiple rounds of data are needed to support safety."

Answered by AI

In how many different geographical areas is this research being conducted?

"There are 41 trial sites currently operational, located in Mishawaka, Houston, Miami, and other locations."

Answered by AI

What has been the general response to Baloxavir Marboxil in other scientific investigations?

"Currently, there are 4 ongoing trials investigating the efficacy of Baloxavir Marboxil. 3 of these trials are in Phase 3. Most of the clinical trials for Baloxavir Marboxil are located in Berazategui, Massachusetts; however, there are 350 total locations conducting studies on this medication."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
Alabama
Other
Texas
How old are they?
18 - 65
What site did they apply to?
Cahaba Research, Inc.
Long Beach Clinical Trials
Fairway Medical Clinic
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0

Why did patients apply to this trial?

To learn about my copd. Prozac, anti depressants,.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Cahaba Research, Inc.: < 24 hours
Average response time
  • < 1 Day
~59 spots leftby Apr 2024