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Flu drug cocktail shows promise in hospitalized patients

NCT ID NCT04327791

Disease control Sponsor: Bassett Healthcare Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 2/3 trial tested whether adding baloxavir to standard oseltamivir treatment helps hospitalized flu patients clear the virus faster. Fifteen adults with confirmed influenza were randomly assigned to receive either the combination or oseltamivir alone. The main goal was to measure how quickly the virus disappeared from nasal swabs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
baloxavir and oseltamivir
What this could lead to
If it works, this combination could help hospitalized flu patients clear the virus faster and reduce complications.
What could go wrong
This was a very small early-stage trial with only 15 participants, so results may not apply broadly. The combination also carries unknown risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

15 people

The number who actually took part.

Started

Apr 2020

Finished

Oct 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

influenza

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Influenza

Contacts and locations

Locations

  • Bassett Medical Center

    Cooperstown, New York, 13326, United States

  • Baystate Medical Center

    Springfield, Massachusetts, 01199, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

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