RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2020-04-03
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04327791

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

jennifer Victory, RN
CONTACT
6075476965
jennifer.victory@bassett.org
Daniel Freilich, MD
CONTACT
6075474586
daniel.freilich@bassett.org

Principal Investigator

Daniel Freilich, MD
PRINCIPAL_INVESTIGATOR
Bassett Medical Center

Study Locations (Sites)

Baystate Medical Center
Springfield, Massachusetts, 01199
United States
Bassett Medical Center
Cooperstown, New York, 13326
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: Bassett Healthcare

  • Daniel Freilich, MD, PRINCIPAL_INVESTIGATOR, Bassett Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-04-03
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2020-04-03
Study Completion Date2025-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Influenza