NCT04327791

Brief Summary

This is a randomized, double-blind, placebo-controlled Phase 2-like, investigator-directed trial of hospitalized patients with laboratory confirmed influenza. Eligible and consented patients will be randomly assigned, in a 1:1 ratio, to one of two groups: Group 1, the combination treatment group (oseltamivir and baloxavir); Group 2, the standard treatment group (oseltamivir and placebo).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2020

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

April 3, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

4.2 years

First QC Date

March 27, 2020

Last Update Submit

October 27, 2023

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

  • Time to Clearance of Viral Shedding

    influenza viral titer obtained by nasal swab using qCulture

    30 days

Study Arms (2)

baloxavir

EXPERIMENTAL

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

Drug: Baloxavir

placebo

PLACEBO COMPARATOR

placebo po once

Drug: Placebos

Interventions

BaloxavirDRUG

administered PO once

baloxavir
PlacebosDRUG

administered PO once

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults \>/= 18 years old
  • Laboratory confirmed influenza A and/or B (rapid test or PCR)
  • Able to be enrolled, randomized, and dosed with study drug within 8 hours of the decision to admit patient to hospital for treatment of influenza
  • Oseltamivir treatment ordered by clinical team AND patient is able to be enrolled:
  • Prior to the initial dose of oseltamivir OR
  • Within 60 minutes after the initial dose of oseltamivir
  • Subject or Legally Authorized Representative able to and willing to provide written informed consent
  • Able to commit to 30 days of follow up
  • Weight \> 40 kg
  • SARS-CoV-2 PCR swab sent within 1 week of enrollment

You may not qualify if:

  • ESRD not undergoing hemodialysis (HD) or peritoneal dialysis (CAPD)
  • Severe hepatic insufficiency, cirrhosis, acute or chronic liver failure
  • Nausea/vomiting, aspiration risk, or other conditions precluding the ability to use oral medications (if patient is NPO including meds, otherwise unable to swallow oral medications)
  • Influenza medication use within the prior week, other than the initial oseltamivir given during this hospitalization for this episode of influenza
  • Oseltamivir or baloxavir allergy or intolerance
  • Pregnancy (need negative pregnancy test (urine or blood) in reproductive age women)
  • Absence of dependable contraception in reproductive age women
  • Inability to obtain informed consent
  • Refusal of oseltamivir therapy by patient as baseline treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

RECRUITING

Bassett Medical Center

Cooperstown, New York, 13326, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

baloxavir

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Daniel Freilich, MD

    Bassett Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

jennifer Victory, RN

CONTACT

6075476965jennifer.victory@bassett.org

Daniel Freilich, MD

CONTACT

6075474586daniel.freilich@bassett.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending physician - hospitalist

Study Record Dates

First Submitted

March 27, 2020

First Posted

March 31, 2020

Study Start

April 3, 2020

Primary Completion

June 1, 2024

Study Completion

June 1, 2025

Last Updated

October 30, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(3)