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Antiviral

Baloxavir and Oseltamivir for Influenza

Phase 4
Waitlist Available
Research Sponsored by Insight Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 months each influenza season
Awards & highlights

Study Summary

This trial will compare the effectiveness of two different drugs in preventing influenza outbreaks in nursing homes.

Eligible Conditions
  • Flu
  • Influenza

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 months each influenza season
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 months each influenza season for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total number of ILI cases defined, following the index influenza case identification in nursing homes randomized to baloxavir or oseltamivir
Secondary outcome measures
Facility-level data on antiviral courses of treatment administered from Medication Administration Records
Hospitalizations from Minimum Data Set (MDS) 3.0 (interim) and Medicare A claims
Mortality from Medicare Vital Status File
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BaloxavirExperimental Treatment1 Intervention
Nursing homes randomized to receive baloxavir for treatment and chemoprophylaxis for influenza.
Group II: OseltamivirActive Control1 Intervention
Nursing homes randomized to receive oseltamivir for treatment and chemoprophylaxis for influenza.

Find a Location

Who is running the clinical trial?

Insight Therapeutics, LLCLead Sponsor
8 Previous Clinical Trials
31,207 Total Patients Enrolled
Brown UniversityOTHER
456 Previous Clinical Trials
562,081 Total Patients Enrolled
Case Western Reserve UniversityOTHER
299 Previous Clinical Trials
259,020 Total Patients Enrolled

Media Library

Baloxavir (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT05012189 — Phase 4
Flu Research Study Groups: Oseltamivir, Baloxavir
Flu Clinical Trial 2023: Baloxavir Highlights & Side Effects. Trial Name: NCT05012189 — Phase 4
Baloxavir (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05012189 — Phase 4

Frequently Asked Questions

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

Has Baloxavir received regulatory approval from the Food and Drug Administration?

"The safety of Baloxavir has been established through its Phase 4 trial, thus earning a score of 3."

Answered by AI

What are the traditional applications of Baloxavir?

"Baloxavir is typically prescribed for fever, but it also has the potential to be used in combating influenza pandemics. Furthermore, this medication can help mitigate symptoms related to Influenza A and B viruses."

Answered by AI

Is a person of any age below 55 years old able to partake in this research?

"Per the guidelines of this medical trial, anyone between 18 years and 120 years old is welcome to participate."

Answered by AI

Is there still a possibility to join this research endeavor?

"Clinicaltrials.gov indicates that this medical research is presently seeking participants, with the trial being initially published on August 6th 2021 and having been most recently updated on November 18th 2022."

Answered by AI

What previous research has been undertaken regarding the efficacy of Baloxavir?

"Presently, there are 11 clinical trials researching Baloxavir. 2 of these active investigations have progressed to Phase 3. The majority of research on this drug is conducted in New york City, although 351 sites worldwide host studies for it."

Answered by AI

How many individuals have signed up to take part in this investigation?

"Affirmative. The information hosted on clinicaltrials.gov implies that this research endeavour, which was initially posted on August 6th 2021, is actively searching for participants. Approximately 1000 individuals need to be sourced from a single medical centre."

Answered by AI

Is my eligibility in compliance with the requirements for this experiment?

"1000 participants are being sought for this influenza trial, which is open to humans aged 18 or above and 120 or below."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Insight Therapeutics, LLC
What portion of applicants met pre-screening criteria?
Met criteria
~273 spots leftby Apr 2025