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Double antiviral attack: could two flu drugs beat one for vulnerable patients?

NCT ID NCT04712539

Disease control Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Updated 3 times

Summary

This phase 2 trial tests whether combining two antiviral drugs, baloxavir and oseltamivir, works better than oseltamivir alone for severe flu in people with weakened immune systems (such as blood cancer patients or stem cell transplant recipients). The study will measure how quickly the virus clears and whether the combination reduces hospital stays or complications. 60 participants are being recruited at MD Anderson Cancer Center.

What this could mean

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

Active substance
Baloxavir marboxil and oseltamivir
What this could lead to
If it works, this combination could offer a more effective treatment for severe flu in people with weakened immune systems, reducing hospital stays and complications.
What could go wrong
This is a small, early-phase trial (60 participants) in a very specific group (cancer or transplant patients). The combination may not work better than oseltamivir alone, and there is a risk of side effects or drug resistance.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

Feb 2028

An estimate. End dates often move.

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

12 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. Hematopoeitic cell transplant recipients OR hematological malignancy patients 2. Diagnosed with influenza ⱡ 3. Evidence of LRTI\* or high risk upper respiratory tract infection (URTI)\*\* ⱡ A positive multiplex PCR for influenza is required to confirm a diagnosis of influenza infection. \* LRTI will be defined as influenza cases that have evidence of disease below the level of the trachea on either imaging only (possible LRTI), imaging and microbiological evidence of lower airway disease with a bronchoscopy (probable LRTD) or pathological evidence of disease via biopsy (proven LRTI). \*\* High risk URI will be defined as those cases of influenza that do not have microbiological nor radiological evidence of LRTI, yet they have an immunodeficiency scoring index (ISI) of 3 or greater as defined by Shah D et al (19) for HCT recipients or severe neutropenia (ANC ≤500 cells/ml) and/or lymphopenia (ALC ≤200 cells/ml) for HM patients. Exclusion criteria: 1. Patient requires mechanical ventilation at time of enrollment 2. Patient is younger than the age of 12 years old 3. The patient is unable to tolerate oral therapy 4. The patient is pregnant at screening ( Positive serum β-HCG (beta-human chorionic gonadotropin) test for women of child-bearing potential). 5. The patient is on a prohibited medication. These include Influenza antiviral drugs with the exception of oseltamivir and baloxavir (such as peramivir, laninamivir, zanamivir, rimantadine, umifenovir or amantadine) and herbal therapies. 6. The patient is unable to consent will be excluded

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm influenza

As listed by the trial registrant

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

Hematopoietic and lymphoid cell neoplasm Influenza

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • M D Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.