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Baloxavir + Oseltamivir for Flu (COMBO 1 Trial)
COMBO 1 Trial Summary
This trial is testing whether a combination of two drugs is more effective than one drug at treating influenza in hospitalized patients.
COMBO 1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOMBO 1 Trial Timeline
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 • NCT04141930COMBO 1 Trial Design
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Who is running the clinical trial?
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- I weigh more than 40 kg.I am 18 years old or older.I have severe liver problems.I cannot take pills by mouth due to nausea or risk of inhaling them.I have chosen not to take oseltamivir as my initial treatment.I am starting or have just started Oseltamivir as prescribed.I can start the study drug within 8 hours of being admitted for flu treatment.I have end-stage renal disease but am not on dialysis.I have not taken any flu medications in the past week, except for the first dose of oseltamivir given in this hospital stay.You have been diagnosed with influenza A and/or B through a lab test.You are allergic to or cannot tolerate oseltamivir or baloxavir.You need to have taken a COVID-19 test within a week before joining the trial.Women of childbearing age must have a negative pregnancy test.
- Group 1: placebo
- Group 2: baloxavir
- 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
What similar research has been conducted with Baloxavir?
"Baloxavir is being researched in 2 different ongoing trials, 1 of which is in Phase 3. The majority of the clinical trials are situated in Norfolk, Virginia; although, there are 2 research sites for Baloxavir."
How many volunteers will be given the experimental treatment?
"The clinicaltrials.gov website indicates that this research is ongoing and looking for volunteers. The 60 participants will be recruited from a single location, and the study's first posting was on April 3rd, 2020 with an update on August 23rd, 2021."
Is this a new medical study?
"There are 2 ongoing trials for Baloxavir in 2 cities and 1 country. The first trial was conducted in 2020 and, sponsored by Genentech Inc., involved 60 patients. As of now, 241 have completed their Phase 2 & 3 drug approval stage."
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