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One-Dose flu drug shows promise in kids

NCT ID NCT06774859

Symptom relief Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared a single dose of baloxavir marboxil to a 5-day course of oseltamivir in 100 Chinese children aged 1 to 12 with flu symptoms. The main goal was to check safety, including side effects. Researchers also measured how quickly symptoms like cough and fever improved. The study is complete, and results will help understand if a one-dose option is safe and effective for children.

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

100 people

The number who actually took part.

Started

Oct 2024

Finished

May 2025

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

1 year to 11 years

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: * A participant who has a diagnosis of influenza virus infection and meets all the following conditions: * Fever ≥ 38°C (tympanic temperature) at screening * At least one of the respiratory symptoms of influenza virus infection * A rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) shows positive for influenza A/B, e.g., point-of-care/local laboratory results with use of nasal aspirate, throat swab, or nasal drip/droplet (or other appropriate sample) * The time interval between the onset of symptoms and screening is ≤ 48 hours * PCR (-) or antigen test (-) for severe acute respiratory virus-coronavirus 2 (SARS-CoV-2) using point-of-care/local laboratory test with nasal aspirate, throat swab, or nasal drip/droplet (or other appropriate sample) Exclusion Criteria: * A participant having severe influenza virus infection symptoms requiring inpatient treatment * Received systemic corticosteroid or immunosuppressive therapy * Primary immunodeficiency syndrome * History of organ transplantation * Human immunodeficiency virus (HIV) infection * Immunization with a live/attenuated influenza vaccine in 2 weeks prior to randomization * Previous malignancy within the last 5 years or has an active cancer at any site * A participant who received any medications with anti-flu effect such as baloxavir, peramivir, oseltamivir, zanamivir, favipiravir, arbidol, amantadine or traditional Chinese anti-influenza medicines within 30 days before screening * Diagnosed with or suspected SARS-CoV-2 infection, or close contacts of diagnosed or suspected SARS-CoV-2 infected patients * Severe underlying disease or condition potentially affecting study evaluation in the opinion of the investigator/sub-investigator * A participant who received an investigational or unapproved drug product within 30 days or 5 x the half-life before screening, whichever is longer

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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

  • Chengdu Women's and Children's Central Hospital

    Chengdu, 610091, China

  • Childern's Hospital of Chongqing Medical University

    Chongqing, DUMMY_VALUE, China

  • Chongqing University Jiangjin Hospital

    Chongqing, 402260, China

  • Hebei Petro China Central Hospital

    Langfang, 065000, China

  • Liaocheng people's Hospital

    Liaocheng, 252000, China

  • Linfen Central Hospital

    Linfen, 041000, China

  • Liuzhou People's Hospital

    Liuzhou, 545006, China

  • Ningbo Women and Children's Hospital

    Ningbo, 315021, China

  • Peoples Hospital of Hunan Province

    Changsha, 410007, China

  • Sanmenxia Central Hospital

    Sanmenxia, DUMMY_VALUE, China

  • The First Affiliated Hospital, Shaoyang University

    Shaoyang, DUMMY_VALUE, China

  • The First People's Hospital of Changde

    Changde, DUMMY_VALUE, China

  • The Second Affiliated Hospital of Shantou University Medical College

    Shantou, 515051, China

  • The Third People's Hospital of Hainan Province

    Sanya, 572000, China

  • University of Chinese Academy of Sciences Shenzhen Hospital

    Shenzhen, 518107, China

  • Xiamen Maternal and Child Health Hospital

    Xiamen, 361001, China

More trials for these conditions

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