InfluenzaNCT06762587
Oseltamivir and Baloxavir Marboxil for Prophylaxis Against Influenza Under a Hospital-based Setting
A study testing Baloxavir Marboxil and Oseltamivir in people with Influenza and Influenza Prophylaxis, run by Capital Medical University at 1 site in China.
Trial summary
This study aims to randomly assign close contacts of hospitalized influenza virus patients to receive baloxavir marboxil prophylaxis, oseltamivir prophylaxis or no antiviral prophylaxis and monitor the incidence of clinical influenza, evaluating the prophylaxis efficiency of antivirals in a hospital setting. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Influenza Prophylaxis, Nosocomial Infection
- What is being tested?
- Baloxavir Marboxil and Oseltamivir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2025to 5 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Index patient:
- 1. Patients or accompanying caregivers hospitalized at participating medical institutions.
- 2.The subject and/or their legal guardian both agree to participate in this clinical study, sign the informed consent form, and are able to comply with the study requirements for follow-up and completion of all study procedures and assessments.
- 3.Age ≥ 2 years.
- 4.Influenza nucleic acid positivity confirmed by throat swab, sputum and other respiratory sample through rapid antigen testing (RAT) or PCR.
- Close contact:
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- 1.Patients or accompanying caregivers hospitalized at participating medical institutions.
- 2.The subject and/or their legal guardian both agree to participate in this clinical study, sign the informed consent form, and are able to comply with the study requirements for follow-up and complete all study procedures and assessments
- 3.Age ≥ 12 years.
- 4.Expected to remain hospitalized for ≥ 72 hours.
- 5.The room must contain at least one hospitalized index patient diagnosed with influenza virus within the past 72 hours, and the contact is expected to stay with the hospitalized index patient in the ward for more than 24 hours.
- 6.Throat swab on the first day tested negative for influenza virus by PCR.
Who cannot join
- Close contacts
- 1.With known allergies to the active ingredients or excipients of the investigational drug.
- 2.Close contacts diagnosed with or having experienced an influenza virus infection within the past 12 weeks.
- 3.Close contacts who have used antiviral drugs (including neuraminidase inhibitors, hemagglutinin inhibitors, and M2 ion channel blockers, such as oseltamivir, zanamivir, peramivir, favipiravir, abidol, baloxavir marboxil, amantadine, rimantadine, or any other antiviral drugs approved by NMPA) within the 2 weeks prior to screening.
- 4.Close contacts known to be pregnant or breastfeeding.
- 5. Having experienced fever (axillary temperature ≥37.3°C) in the past 3 days prior to screening.
- 6.Subjects deemed unsuitable to participate in the study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Bin Cao, Ph.D, 86 010 84206264, caobin_ben@163.com
Yeming Wang, Ph.D, wwyymm_love@163.com
About this study
Official title: A Randomized, Open-Label Clinical Study on the Efficacy of Baloxavir Marboxil and Oseltamivir for Post-Exposure Prevention of Influenza in a Hospital Setting
This study aims to randomly assign close contacts of hospitalized influenza virus patients to receive baloxavir marboxil prophylaxis, oseltamivir prophylaxis or no antiviral prophylaxis and monitor the incidence of clinical influenza, evaluating the prophylaxis efficiency of antivirals in a hospital setting.
Read the detailed description
This study will enroll hospitalized patients diagnosed with influenza virus infection (index patients) and their roommates who are not infected with the influenza virus (close contacts). The close contacts will be randomly assigned in a 1:1:1 ratio to receive baloxavir marboxil prophylaxis, oseltamivir prophylaxis or no antiviral prophylaxis. The incidence of clinical influenza (confirmed by reverse-transcriptase polymerase chain reaction (RT-PCR) testing, along with fever and one respiratory symptom) will be monitored to evaluate the efficiency of antiviral prophylaxis in a hospital setting. The index patients will receive standard treatment for influenza infection.
- Conditions
- Influenza, Influenza Prophylaxis, Nosocomial Infection
- Being tested
- Baloxavir Marboxil, Oseltamivir
- Keywords
- influenza, influenza prophylaxis, baloxavir marboxil, oseltamivir, nosocomial infection
- Medical subject headings
- Influenza, Human, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baloxavir MarboxilDrug
Baloxavir marboxil will be administered on the first day following the close contact's enrollment in this study. Participants weighing ≤80 kg will receive 40 mg of baloxavir marboxil, while those weighing ≥80 kg will receive 80 mg.
OseltamivirDrug
Oseltamivir will be administered once daily for 5 consecutive days following the close contact's enrollment in this study. Participants will receive 75 mg of oseltamivir once each day.
| Study group | Role | What they receive |
|---|---|---|
| Baloxavir Marboxil | Experimental | Baloxavir marboxil will be administered on the first day following the close contact's enrollment in this study. Participants weighing ≤80 kg will receive 40 mg of baloxavir marboxil, while those weighing ≥80 kg will receive 80 mg. Receives: Drug: Baloxavir Marboxil |
| Oseltamivir Arm | Experimental | Oseltamivir will be administered once daily for 5 consecutive days following the close contact's enrollment in this study. Participants will receive 75 mg of oseltamivir once each day Receives: Drug: Oseltamivir |
| Control Arm | No intervention | No antivirals will be administered to the contacts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Clinical Influenza within a 5-day period
Incidence of Clinical Influenza within a 5-day period is defined as the percentage of contacts who become positive for influenza based on reverse-transcriptase polymerase chain reaction (RT-PCR) testing or rapid antigen testing (RAT), along with fever (defined as axillary temperature ≥37.3℃) and at least one respiratory symptom.
Measured: up to 5 days
Secondary outcomes (3)
Incidence of influenza within a 5-day period
Incidence of Influenza within a 5-day period is defined as the percentage of contacts who become positive for influenza based on reverse-transcriptase polymerase chain reaction (RT-PCR) testing or rapid antigen testing (RAT).
Measured: up to 5 days
Incidence of Clinical Influenza within a 10-day period
Incidence of Clinical Influenza within a 10-day period is defined as the percentage of contacts who become positive for influenza based on reverse-transcriptase polymerase chain reaction (RT-PCR) testing or rapid antigen testing (RAT), along with fever (defined as axillary temperature ≥37.3℃) and at least one respiratory symptom.
Measured: up to 10 days
Susceptibility to antivirals by phenotyping post-baseline samples with novel mutation
Susceptibility to antivirals by phenotyping post-baseline samples with novel mutation is defined as the percentage of contacts infected with resistance-associated treatment-emergent influenza variants.
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start5 Jan 2025 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion5 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Chinese Academy of Medical Sciences
- Responsible party
- Principal investigator, Bin Cao, Capital Medical University
- Investigators
- Bin Cao, Ph.D, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762587
- Sponsor's protocol ID
- 2024-KY-401
- Status last verified
- Jan 2025
- First submitted
- 30 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li X, Chu Z, Peng M, Yan K, Guan Y, Yang C, Xu J, Qiu L, Liu T. A randomised, open-label clinical study on the efficacy of baloxavir marboxil and oseltamivir for post-exposure prevention of influenza in a hospital setting: a study protocol. BMJ Open. 2026 Aug 19;16(8):e118748. doi: 10.1136/bmjopen-2026-118748.
PubMed 42624586
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Clinical Study on the Efficacy of Baloxavir Marboxil and Oseltamivir for Post-Exposure Prevention of Influenza in a Hospital Setting
- ClinicalTrials.gov ID
- NCT06762587
- Acronym / sponsor ID
- 2024-KY-401
- Conditions
- Influenza, Influenza Prophylaxis, Nosocomial Infection
- Keywords
- influenza, influenza prophylaxis, baloxavir marboxil, oseltamivir, nosocomial infection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Chinese Academy of Medical Sciences
- Study start
- 5 Jan 2025 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 5 May 2025 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to randomly assign close contacts of hospitalized influenza virus patients to receive baloxavir marboxil prophylaxis, oseltamivir prophylaxis or no antiviral prophylaxis and monitor the incidence of clinical influenza, evaluating the prophylaxis efficiency of antivirals in a hospital setting.
Detailed description
This study will enroll hospitalized patients diagnosed with influenza virus infection (index patients) and their roommates who are not infected with the influenza virus (close contacts). The close contacts will be randomly assigned in a 1:1:1 ratio to receive baloxavir marboxil prophylaxis, oseltamivir prophylaxis or no antiviral prophylaxis. The incidence of clinical influenza (confirmed by reverse-transcriptase polymerase chain reaction (RT-PCR) testing, along with fever and one respiratory symptom) will be monitored to evaluate the efficiency of antiviral prophylaxis in a hospital setting. The index patients will receive standard treatment for influenza infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baloxavir Marboxil | Experimental | Drug: Baloxavir MarboxilBaloxavir marboxil will be administered on the first day following the close contact's enrollment in this study. Participants weighing ≤80 kg will receive 40 mg of baloxavir marboxil, while those weighing ≥80 kg will receive 80 mg. |
| Oseltamivir Arm | Experimental | Drug: OseltamivirOseltamivir will be administered once daily for 5 consecutive days following the close contact's enrollment in this study. Participants will receive 75 mg of oseltamivir once each day |
| Control Arm | No intervention | –No antivirals will be administered to the contacts. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Index patient:
- 1. Patients or accompanying caregivers hospitalized at participating medical institutions.
- 2.The subject and/or their legal guardian both agree to participate in this clinical study, sign the informed consent form, and are able to comply with the study requirements for follow-up and completion of all study procedures and assessments.
- 3.Age ≥ 2 years.
- 4.Influenza nucleic acid positivity confirmed by throat swab, sputum and other respiratory sample through rapid antigen testing (RAT) or PCR.
Key exclusion criteria (7 listed)
- Close contacts
- 1.With known allergies to the active ingredients or excipients of the investigational drug.
- 2.Close contacts diagnosed with or having experienced an influenza virus infection within the past 12 weeks.
- 3.Close contacts who have used antiviral drugs (including neuraminidase inhibitors, hemagglutinin inhibitors, and M2 ion channel blockers, such as oseltamivir, zanamivir, peramivir, favipiravir, abidol, baloxavir marboxil, amantadine, rimantadine, or any other antiviral drugs approved by NMPA) within the 2 weeks prior to screening.
- 4.Close contacts known to be pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baloxavir MarboxilBaloxavir marboxil will be administered on the first day following the close contact's enrollment in this study. Participants weighing ≤80 kg will receive 40 mg of baloxavir marboxil, while those weighing ≥80 kg will receive 80 mg. | Drug | Baloxavir Marboxil |
| OseltamivirOseltamivir will be administered once daily for 5 consecutive days following the close contact's enrollment in this study. Participants will receive 75 mg of oseltamivir once each day. | Drug | Oseltamivir Arm |
Primary outcome
Incidence of Clinical Influenza within a 5-day period
Time frame: up to 5 days
Incidence of Clinical Influenza within a 5-day period is defined as the percentage of contacts who become positive for influenza based on reverse-transcriptase polymerase chain reaction (RT-PCR) testing or rapid antigen testing (RAT), along with fever (defined as axillary temperature ≥37.3℃) and at least one respiratory symptom.
3 secondary outcomes
Incidence of influenza within a 5-day period
Time frame: up to 5 days
Incidence of Clinical Influenza within a 10-day period
Time frame: up to 10 days
Susceptibility to antivirals by phenotyping post-baseline samples with novel mutation
Time frame: up to 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Derived from this study: PubMed 42624586Li X, Chu Z, Peng M, Yan K, Guan Y, Yang C, Xu J, Qiu L, Liu T. A randomised, open-label clinical study on the efficacy of baloxavir marboxil and oseltamivir for post-exposure prevention of influenza in a hospital setting: a study protocol. BMJ Open. 2026 Aug 19;16(8):e118748. doi: 10.1136/bmjopen-2026-118748.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bin Cao, Ph.D principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baloxavir Marboxil and Oseltamivir in people with Influenza and Influenza Prophylaxis, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yeming Wang, Ph.D. (+86 84206264, wwyymm_love@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Clinical Influenza within a 5-day period (time frame: up to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06762587, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.