COmbination Therapy With Baloxavir and Oseltamivir 1 for Hospitalized Patients With Influenza (The COMBO Trial 1)
NCT ID: NCT04327791
Last Updated: 2023-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2020-04-03
2025-06-01
Brief Summary
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Detailed Description
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Experimental Design and Methods In a randomized, double-blind, placebo-controlled Phase 2-like, investigator-directed trial, hospitalized patients with laboratory confirmed influenza meeting inclusion and exclusion criteria, will be provided information on the trial, offered enrollment, and enrolled randomly in a 1:1 ratio to one of two groups upon signing of the study's informed consent form: Group 1, the combination treatment group (oseltamivir and baloxavir); Group 2, the standard treatment group (oseltamivir and placebo).
* Group 1, the combination treatment group will receive oseltamivir and baloxavir
* Oseltamivir: 75 mg po bid for 5 days
* Baloxavir: 40 mg po once for wt \< 80 kg OR 80 mg po once for wt \>/= 80 kg
* Group 2, the standard treatment group will receive oseltamivir and placebo
* Oseltamivir: 75 mg po bid for 5 days
* Placebo: Once
Oseltamivir dosing may be reduced for patients with decreased renal function as follows, per treating physician:
* CrCl \> 60 mL/minute: No dosage adjustment
* CrCl \> 30 to 60 mL/minute: 30 mg po bid
* CrCl \> 10 to 30 mL/minute: 30 mg po qd
* HD: 30 mg po once and 30 mg po after each HD session
* CAPD: 30 mg po once
* CRRT: 30 mg po qd After assignment of a unique study number after signing informed consent, baseline data will be collected at time 0 including personal and clinical information and protocol directed laboratory specimens - nasal swabs for influenza PCR for patients who only had a rapid antigen test and blood specimens for patients who consent to additional blood drawing (for improved efficacy and safety analyses; not required for enrollment). Patients will be given oseltamivir by their healthcare providers. Research personnel's only involvement for oseltamivir dosing will be to remind providers that earlier treatment improves efficacy. Patients will then be given a single dose of baloxavir or placebo by the study's CRC as per a computerized random allocation scheme with dose determined by weight (as above); the CRC will notify the patient's provider that the patient has been given the single (blinded) dose. At time 1, 2, 3, 4, 7, and 30 days, nasal swabs will again be obtained, clinical information will be obtained from the patient via interview and review of the EMR, and blood specimens for patients who consented to additional blood drawing. Follow up will continue for 30 days.
Efficacy and adjudicated safety data points will be assessed by a Data Monitoring Committee (DMC) quarterly and as needed throughout the trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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baloxavir
Baloxavir: 40 mg po once for wt \< 80 kg OR 80 mg po once for wt \>/= 80 kg
Baloxavir
administered PO once
placebo
placebo po once
Placebos
administered PO once
Interventions
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Baloxavir
administered PO once
Placebos
administered PO once
Eligibility Criteria
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Inclusion Criteria
2. Laboratory confirmed influenza A and/or B (rapid test or PCR)
3. 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
4. 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
5. Subject or Legally Authorized Representative able to and willing to provide written informed consent
6. Able to commit to 30 days of follow up
7. Weight \> 40 kg
8. SARS-CoV-2 PCR swab sent within 1 week of enrollment
Exclusion Criteria
2. Severe hepatic insufficiency, cirrhosis, acute or chronic liver failure
3. 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)
4. Influenza medication use within the prior week, other than the initial oseltamivir given during this hospitalization for this episode of influenza
5. Oseltamivir or baloxavir allergy or intolerance
6. Pregnancy (need negative pregnancy test (urine or blood) in reproductive age women)
7. Absence of dependable contraception in reproductive age women
8. Inability to obtain informed consent
9. Refusal of oseltamivir therapy by patient as baseline treatment
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Viroclinics Biosciences B.V.
INDUSTRY
Bassett Healthcare
OTHER
Responsible Party
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Daniel Freilich, MD
attending physician - hospitalist
Principal Investigators
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Daniel Freilich, MD
Role: PRINCIPAL_INVESTIGATOR
Bassett Medical Center
Locations
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Baystate Medical Center
Springfield, Massachusetts, United States
Bassett Medical Center
Cooperstown, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1579493
Identifier Type: -
Identifier Source: org_study_id
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