- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04327791
COmbination Therapy With Baloxavir and Oseltamivir 1 for Hospitalized Patients With Influenza (The COMBO Trial 1) (COMBO 1)
Study Overview
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-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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Daniel Freilich, MD
- Phone Number: 6075474586
- Email: daniel.freilich@bassett.org
Study Contact Backup
- Name: jennifer Victory, RN
- Phone Number: 6075476965
- Email: jennifer.victory@bassett.org
Study Locations
-
-
Massachusetts
-
Springfield, Massachusetts, United States, 01199
- Recruiting
- Baystate Medical Center
-
Contact:
- Andres Santana
- Phone Number: 413-794-4231
- Email: Andres.Santana@baystatehealth.org
-
Principal Investigator:
- Armando Paez, MD
-
-
New York
-
Cooperstown, New York, United States, 13326
- Recruiting
- Bassett Medical Center
-
Principal Investigator:
- daniel freilich, MD
-
Contact:
- jennifer Victory, RN
- Phone Number: 607-547-6965
- Email: jennifer.victory@bassett.org
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health & Science University
-
Principal Investigator:
- Akram Khan, MD
-
Contact:
- Jose Pena
- Phone Number: 503-494-2736
- Email: penaj@ohsu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: baloxavir
Baloxavir: 40 mg po once for wt < 80 kg OR 80 mg po once for wt >/= 80 kg
|
administered PO once
|
Placebo Comparator: placebo
placebo po once
|
administered PO once
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Clearance of Viral Shedding
Time Frame: 30 days
|
influenza viral titer obtained by nasal swab using qCulture
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Freilich, MD, Bassett Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1579493
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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