Combination treatment for hospitalized patients with influenza

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

This study is testing if a combination of two flu medications can help hospitalized patients with influenza get better faster than the usual treatment.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bassett Healthcare (other)
• Locations: 3 sites (Springfield, Massachusetts and 2 other locations)
• Trial ID: NCT04327791 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a combination therapy using baloxavir and oseltamivir compared to standard treatment with oseltamivir alone in hospitalized patients with confirmed influenza. The study is designed as a randomized, double-blind, placebo-controlled trial, enrolling up to 60 patients who will be assigned to either the combination treatment group or the standard treatment group. Patients will receive the treatments within 8 hours of hospital admission, and their progress will be monitored for 30 days post-treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with laboratory-confirmed influenza who can be treated within 8 hours of hospital admission.

Not a fit: Patients with end-stage renal disease not undergoing dialysis or severe hepatic insufficiency may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to improved outcomes for hospitalized patients suffering from influenza.

How similar studies have performed: Other studies have explored similar antiviral combinations, but this specific combination therapy is novel in this hospitalized patient population.

Eligibility 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 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

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, 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

Where this trial is running

Springfield, Massachusetts and 2 other locations

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

Study contacts

• Principal investigator: Daniel Freilich, MD — Bassett Medical Center
• Study coordinator: jennifer Victory, RN

Conditions: Influenza