Status:
UNKNOWN
COmbination Therapy With Baloxavir and Oseltamivir 1 for Hospitalized Patients With Influenza (The COMBO Trial 1)
Lead Sponsor:
Bassett Healthcare
Collaborating Sponsors:
Genentech, Inc.
Viroclinics Biosciences B.V.
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 r...
Detailed Description
Up to 60 hospitalized patients with laboratory confirmed influenza who provide informed consent and meet trial inclusion/exclusion criteria. Experimental Design and Methods In a randomized, double-bl...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
April 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04327791
Start Date
April 3 2020
End Date
June 1 2025
Last Update
October 30 2023
Active Locations (3)
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1
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
2
Bassett Medical Center
Cooperstown, New York, United States, 13326
3
Oregon Health & Science University
Portland, Oregon, United States, 97239