One dose to block the flu: baloxavir put to the test in households

NCT ID NCT07827599

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing whether a single dose of the antiviral drug baloxavir marboxil can stop influenza from spreading among people who live with someone who has the flu. The trial enrolls households in China where one person has confirmed influenza and up to five other members agree to take part. Household contacts receive either baloxavir or a placebo, and researchers track how many develop fever and respiratory symptoms with a positive flu test. The goal is to see if early treatment with baloxavir can prevent symptomatic flu in close contacts.

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, an antiviral drug given as a single dose
What this could lead to
If it works, a single dose of baloxavir could become a simple way to protect household members from catching influenza after someone brings the virus home.
What could go wrong
This is a phase III trial, so the drug's ability to prevent flu in household settings is not yet proven. Baloxavir can cause side effects such as diarrhea, bronchitis, and headache, and it may not stop all flu infections.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 325 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

5 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Index Participants (Participants With Influenza Virus Infection): * First participant in a household with influenza virus infection in the current influenza season * Fewer than 6 HHCs * Agreement by all household members to participate in the study and comply with the study protocol for the duration of the study * Diagnosed as having influenza with positive rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) result * Onset of symptoms within 48 hours or less at time of signing Informed Consent Form (ICF)/Assent Form * PCR (-) or antigen test (-) for severe acute respiratory virus-coronavirus 2 (SARS-CoV-2) using point-of-care or local laboratory test HHCs of Index Participants: * Lived with the index participant for 48 hours or more prior to informed consent/assent * Meet all the following criteria and are judged not to have influenza virus infection by the investigator: body temperature (tympanic) \<37.5 degrees Celsius (°C); no influenza-like symptoms (cough, sore throat, headache, nasal discharge/nasal congestion, feverishness or chills, muscle or joint pain, or fatigue) at screening; negative RIDT or PCR result for influenza * For participants 12 years of age or older, ability to evaluate influenza symptoms by using a participant influenza symptoms diary; For participants under 12 years of age, capability of parents/caregivers to evaluate influenza symptoms by using a participant influenza symptoms diary * PCR (-) or antigen test (-) for SARS-CoV-2 using point-of-care or local laboratory test Exclusion Criteria: HHCs of Index Participants: * Diagnosed with influenza during the current influenza season * Unable to live with the index patient from screening until Day 10 * Live with a household member who has any influenza-like symptom(s) other than the index participant on the day of screening * Live with household members other than the index participant who was diagnosed with or strongly suspected to have influenza during the current influenza season * Have any underlying diseases requiring systemic (oral or injection), or nasal treatment of antipyretics/analgesics, corticosteroids, or immunosuppressive agents * Immunocompromised * Use of any medications with anti-influenza effect within 30 days prior to screening * Known allergy and/or history of significant intolerance against baloxavir marboxil * Exposure to an investigational drug within 30 days or 5 half-lives of the drug prior to screening, whichever is longer Note: Other protocol-defined inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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