Overview

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

Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bassett Healthcare
Collaborators:
Genentech, Inc.
Viroclinics Biosciences B.V.
Treatments:
Baloxavir
Criteria
Inclusion Criteria

1. Adults >/= 18 years old

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 or started by clinical team

5. Able to and 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

1. ESRD not undergoing hemodialysis (HD) or peritoneal dialysis (CAPD)

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) unless gastric tube use available
(e.g., NG tube, G tube, etc.)

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