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Antiviral

Baloxavir + Oseltamivir for Flu

Phase 2 & 3

Recruiting

Led By Mirella Salvatore, MD

Research Sponsored by Weill Medical College of Cornell University

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)

Age greater than or equal to 18 years at the time of signing the Informed Consent Form/Assent Form

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; day 4; day 7; day 10

Awards & highlights

Study Summary

This trial will study whether a combination of two drugs is more effective than one drug at treating influenza in stem cell transplant patients.

Who is the study for?

Adults over 18 who've had an allogeneic bone marrow transplant and tested positive for flu via PCR can join. They must have symptoms like fever or cough, be able to follow the study plan, and women of childbearing age should use effective birth control. Excluded are those under 40 kg, with COVID-19, prior Baloxavir use for this flu, recent other drug trials, Baloxavir allergies, serious health issues that make participation unsafe, unwillingness to undergo nasal swabs as required by the study schedule.Check my eligibility

What is being tested?

The trial is testing if combining two antiviral drugs (Baloxavir and Oseltamivir) is more effective than using just one in clearing influenza infection in people who've received a bone marrow transplant. Participants will either receive both drugs or one drug plus a placebo without knowing which they're getting.See study design

What are the potential side effects?

Possible side effects include allergic reactions to medication components; digestive issues such as nausea or diarrhea; abnormal liver function tests; headache; fatigue; and potential resistance to the medications.

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 am 18 years old or older.

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I have received a bone marrow transplant from another person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; day 4; day 7; day 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; day 4; day 7; day 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; day 4; day 7; day 10 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Between-treatment-arm difference in the change of influenza viral RNA loads from baseline at the end of treatment as measured by influenza plaque assay (replicating virus).

Between-treatment-arm difference in the change of influenza viral RNA loads from baseline at the end of treatment as measured by quantitative real time polymerase chain reaction.

Change of influenza viral RNA loads from baseline at the end of treatment as measured by quantitative real time polymerase chain reaction.

Secondary outcome measures

Change of influenza viral RNA load from baseline at day 4 and day 7 and 10 in each treatment arm

Change of influenza viral loads from baseline at day 4, 7 and 10 as measured by influenza plaque assay (replicating virus) in each treatment arm

Therapeutic procedure

+8 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active and standard of careActive Control2 Interventions

Active Baloxavir Marboxil and standard of care Oseltamivir

Group II: Placebo and standard of carePlacebo Group2 Interventions

Placebo-matched Baloxavir Marboxil and standard of care Oseltamivir

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,316,522 Total Patients Enrolled

Genentech, Inc.Industry Sponsor

1,540 Previous Clinical Trials

567,869 Total Patients Enrolled

Mirella Salvatore, MDPrincipal InvestigatorWeill Medical College of Cornell University

Media Library

Baloxavir Marboxil (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT05170009 — Phase 2 & 3

Influenza Research Study Groups: Active and standard of care, Placebo and standard of care

Influenza Clinical Trial 2023: Baloxavir Marboxil Highlights & Side Effects. Trial Name: NCT05170009 — Phase 2 & 3

Baloxavir Marboxil (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05170009 — Phase 2 & 3

Frequently Asked Questions

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

Could you give me the updated enrollment numbers for this study?

"That is correct. The clinicaltrials.gov website has the most recent information about the status of this trial. According to the site, this trial was first posted on 4/22/2022 and was last updated on 6/27/2022. They are looking for 30 patients to participate at 1 site."

Answered by AI

Are recruitment efforts for this research project still ongoing?

"Yes, as of right now this study is looking for volunteers. The original posting was on April 22nd, but the most recent update was on June 27th."

Answered by AI

What is the primary purpose of this clinical trial?

"According to the sponsor of this study, Genentech, Inc., the primary outcome being measured is time to viral clearance. This will be assessed over a baseline period of 10 days. Additionally, the study will also measure secondary outcomes including the percentage of patients who experience each influenza-related complication, such as hospitalization, death, sinusitis, otitis media, bronchitis, and radiologically-confirmed pneumonia. These outcomes will be measured as adverse events after the initiation of study treatment."

Answered by AI

What is the usual medical treatment for Active and standard of care?

"The most common use for active and standard of care is treating fever, though it can also be used to manage influenza symptoms during a pandemic outbreak."

Answered by AI

Can you please tell me about other research that has been conducted comparing Active and standard of care?

"As of now, there are 13 trials for Active and standard of care that are ongoing with 4 of those in Phase 3. Most of the trials for Active and standard of care are in New york, New York, but there are a total of 699 locations running clinical trials for Active and standard of care."

Answered by AI

Recent research and studies

Antiviral TherapyJournal

Diagnosis, Management and Outcomes of Adults Hospitalized with Influenza

Lee, Nelson, and Michael G Ison. 2012. “Diagnosis, Management and Outcomes of Adults Hospitalized with Influenza”. Antiviral Therapy. SAGE Publications. doi:10.3851/imp2059.

The Lancet Respiratory MedicineJournal

Effectiveness of Neuraminidase Inhibitors in Reducing Mortality in Patients Admitted to Hospital with Influenza A H1n1pdm09 Virus Infection: A Meta-analysis of Individual Participant Data

Muthuri, Stella G, Sudhir Venkatesan, Puja R Myles, Jo Leonardi-Bee, Tarig S A Al Khuwaitir, Adbullah Al Mamun, Ashish P Anovadiya, et al.. 2014. “Effectiveness of Neuraminidase Inhibitors in Reducing Mortality in Patients Admitted to Hospital with Influenza A H1n1pdm09 Virus Infection: A Meta-analysis of Individual Participant Data”. The Lancet Respiratory Medicine. Elsevier BV. doi:10.1016/s2213-2600(14)70041-4.

Plos OneJournal

Baloxavir Marboxil, a Novel Cap-dependent Endonuclease Inhibitor Potently Suppresses Influenza Virus Replication and Represents Therapeutic Effects in Both Immunocompetent and Immunocompromised Mouse Models

Fukao, Keita, Yoshinori Ando, Takeshi Noshi, Mitsutaka Kitano, Takahiro Noda, Makoto Kawai, Ryu Yoshida, Akihiko Sato, Takao Shishido, and Akira Naito. 2019. “Baloxavir Marboxil, a Novel Cap-dependent Endonuclease Inhibitor Potently Suppresses Influenza Virus Replication and Represents Therapeutic Effects in Both Immunocompetent and Immunocompromised Mouse Models”. Edited by Stefan Pöhlmann. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0217307.

Science Translational MedicineJournal