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Study Summary
This trial is testing the efficacy of baloxavir marboxil in reducing the spread of influenza within households.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 481 Patients • NCT04141930Trial Design
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Who is running the clinical trial?
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- I haven't taken certain antiviral drugs or experimental medications recently.You have tested negative for SARS-CoV-2 using a specific type of test.People with weakened immune systems.You must be diagnosed with acute influenza infection by the doctor in charge of the study.No one in my house has had flu or COVID-19 in the last 4 weeks, and we all meet the study's health requirements.I live with someone who cannot participate in this study based on its rules.I have a fever or symptoms like a cough, sore throat, and headache.I am hospitalized due to severe flu.You must have tested negative for the SARS-CoV-2 virus using a specific test called cobas® SARS-CoV-2 and Influenza A/B test or a similar test from a local lab.I have had a fever or flu symptoms for 2 days or less.I am currently on medication for a non-flu infection.I have a fever or symptoms like a flu.I cannot swallow pills but am not between 5 to 11 years old.I tested positive for influenza A/B using a PCR or rapid test.I have received an experimental antibody treatment for a virus in the past year.I have been diagnosed with the flu by a doctor.I am not pregnant or breastfeeding.You are allergic to baloxavir marboxil or any of the ingredients in the medicine.I live with someone who tested negative for flu and we meet the vaccine and living arrangement criteria.You tested negative for SARS-CoV-2 using a specific test.I was diagnosed with flu or COVID-19 by a doctor in the last month.My child is under 2 years old.The doctor thinks you are likely to have serious problems from the flu.People who have already been part of the study before.You have been part of this study before.I agree to follow the study's rules for preventing pregnancy.
- Group 1: Baloxavir Marboxil
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Cahaba Research, Inc.: < 24 hours
Average response time
- < 1 Day
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