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Antiviral

Baloxavir + Oseltamivir for Flu (COMBO 1 Trial)

Phase 2 & 3

Recruiting

Led By Daniel Freilich, MD

Research Sponsored by Bassett Healthcare

Eligibility Criteria Checklist

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

Must have

Weight > 40 kg

Adults >/= 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

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.

Who is the study for?

Adults over 18, weighing more than 40 kg, hospitalized with confirmed flu who haven't taken other flu meds in the past week can join. They must be able to follow up for 30 days and take a test dose of oseltamivir within an hour. Pregnant women or those not using reliable contraception are excluded.Check my eligibility

What is being tested?

The COMBO Trial compares two treatments for hospitalized flu patients: one group receives both oseltamivir and baloxavir, while the other gets oseltamivir with a placebo. Patients are randomly assigned to either group in equal numbers.See study design

What are the potential side effects?

Possible side effects include allergic reactions to medications, digestive issues like nausea or vomiting, liver problems in susceptible individuals, and complications related to kidney disease requiring dialysis.

COMBO 1 Trial Eligibility Criteria

Inclusion Criteria

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

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I weigh more than 40 kg.

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I am 18 years old or older.

Select...

I am starting or have just started Oseltamivir as prescribed.

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I can start the study drug within 8 hours of being admitted for flu treatment.

COMBO 1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

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

Treatment Details

Study Objectives

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

Primary outcome measures

Time to Clearance of Viral Shedding

Side effects data

From 2020 Phase 4 trial • 481 Patients • NCT04141930

Diarrhea

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Study Drug Eligible

COMBO 1 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: baloxavirExperimental Treatment1 Intervention

Baloxavir: 40 mg po once for wt < 80 kg OR 80 mg po once for wt >/= 80 kg

Group II: placeboPlacebo Group1 Intervention

placebo po once

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bassett HealthcareLead Sponsor

22 Previous Clinical Trials

1,328 Total Patients Enrolled

Genentech, Inc.Industry Sponsor

1,539 Previous Clinical Trials

567,629 Total Patients Enrolled

Viroclinics Biosciences B.V.UNKNOWN

1 Previous Clinical Trials

205 Total Patients Enrolled

Media Library

Baloxavir (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT04327791 — Phase 2 & 3

Influenza Research Study Groups: placebo, baloxavir

Influenza Clinical Trial 2023: Baloxavir Highlights & Side Effects. Trial Name: NCT04327791 — Phase 2 & 3

Baloxavir (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04327791 — Phase 2 & 3

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

COmbination Therapy With Baloxavir and Oseltamivir 1 for Hospitalized Patients With Influenza (The COMBO Trial 1)

Daniel Freilich, MD 2020. "COmbination Therapy With Baloxavir and Oseltamivir 1 for Hospitalized Patients With Influenza (The COMBO Trial 1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04327791.

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