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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Influenza

In brief

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).

Key facts

Study ID

NCT04327791

Run by

Bassett Healthcare

People needed

15

Starts

2020-04-03

Expected to finish

2024-10-01

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Baystate Medical Center — Springfield, Massachusetts, United States
• Bassett Medical Center — Cooperstown, New York, United States
• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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