InfluenzaPhase 3NCT07236814
Suraxavir Marboxil And Oseltamivir for Influenza Prophylaxis Under a Hospital-based Setting
A Phase 3 study testing Suraxavir marboxil and Oseltamivir in people with Influenza, run by Capital Medical University at 2 sites in China.
Trial summary
This study aims to evaluate the efficacy of antiviral prophylaxis in preventing in-hospital influenza transmission. We will enroll hospitalized patients with confirmed influenza (index cases) and their uninfected roommates (room contacts). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- Suraxavir marboxil and Oseltamivir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 384 participants
- Where
- 2 sitesChina
- Study dates
- 28 Nov 2025to 6 Mar 2027
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
1.Inclusion Criteria:
(1)Inclusion Criteria for Index Cases:
① Patients hospitalized at a participating medical institution.
- The subject and/or their legal guardian agrees to participate in this clinical study, has signed the informed consent form, and is able to comply with the protocol requirements for follow-up and complete all study procedures and assessments.
- Age ≥ 2 years.
- Positive for influenza virus as determined by a Rapid Antigen Test (RAT) or Nucleic Acid Amplification Test (NAAT) on a respiratory specimen (e.g., oropharyngeal swab, nasopharyngeal swab, sputum, or bronchoalveolar lavage fluid). (2) Inclusion Criteria for Room Contacts: ① Patients hospitalized at a participating medical institution.
- The subject and/or their legal guardian agrees to participate in this clinical study, has signed the informed consent form, and is able to comply with the protocol requirements for follow-up and complete all study procedures and assessments. ③ Age ≥ 12 years.
- Expected to remain hospitalized for ≥ 72 hours.
- Shares a room with at least one hospitalized index case who has been confirmed with influenza virus infection by RAT or NAAT on a respiratory specimen within the last 120 hours and developed influenza-related symptoms within the last 120 hours, and is expected to share the same room for ≥ 24 hours. ⑥ Negative for influenza virus as determined by a Nucleic Acid Amplification Test (NAAT) on a throat swab collected on Day 1. 3.Exclusion Criteria (1) Index Cases There are no exclusion criteria for index cases. (2) Exclusion Criteria for Room Contacts:
- Room contacts with a known allergy to the active ingredients or excipients of the investigational drugs.
- Room contacts who have been diagnosed with or have had an influenza virus infection in the past 12 weeks.
- Use of any anti-influenza antiviral drugs within 2 weeks prior to screening, including: neuraminidase inhibitors, polymerase inhibitors, hemagglutinin inhibitors, and M2 ion channel blockers (e.g., Oseltamivir, Zanamivir, Peramivir, Favipiravir, Arbidol, Baloxavir Marboxil, Amantadine, or Rimantadine, or other anti-influenza drugs approved by the NMPA).
- Known to be pregnant or breastfeeding. (Subjects who suspect they may be pregnant must report this to the investigator, who will confirm with a pregnancy test).
- History of fever (axillary temperature ≥ 37.3°C) within 72 hours prior to screening.
- Child-Pugh class B or C, or an eGFR ≤ 60 mL·min-¹·(1.73 m²)-¹. ⑦ Any subject deemed unsuitable for participation in the study by the investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
China-Japan Friendship hospital, Beijing, Beijing
Beijing, Beijing Municipality, 100029
Bin Cao, Ph.D, 8610-84206264, caobin_ben@163.com
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Bin Cao, caobin_ben@163.com
About this study
This study aims to evaluate the efficacy of antiviral prophylaxis in preventing in-hospital influenza transmission. We will enroll hospitalized patients with confirmed influenza (index cases) and their uninfected roommates (room contacts). These room contacts will be randomized in a 1:1:1 ratio to one of three prophylactic groups: placebo, suraxavir marboxil, or oseltamivir. The primary outcome will be the rate of influenza infection among the room contacts, which will be monitored to determine the effectiveness of the interventions.
- Conditions
- Influenza
- Being tested
- Suraxavir marboxil, Oseltamivir Placebo, Oseltamivir, Suraxavir marboxil placebo
- Keywords
- influenza, suraxavir marboxil, oseltamivir
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suraxavir marboxilDrug
Suraxavir marboxil (40mg on the first day)
Oseltamivir PlaceboDrug
Oseltamivir placebo(75mg each day during the first five days)
OseltamivirDrug
Oseltamivir (75mg each day during the first five days)
Suraxavir marboxil placeboDrug
Suraxavir marboxil placebo (40mg on the first day).
| Study group | Role | What they receive |
|---|---|---|
| Oseltamivir Arm | Experimental | All subjects will be randomized to receive suraxavir marboxil placebo (40mg on the first day) and oseltamivir (75mg each day during the first five days). Receives: Drug: Oseltamivir; Drug: Suraxavir marboxil placebo |
| suraxavir marboxil | Experimental | All subjects will be randomized to receive oseltamivir placebo(75mg each day during the first five days) and suraxavir marboxil (40mg on the first day). Receives: Drug: Suraxavir marboxil; Drug: Oseltamivir |
| Control Arm | Placebo comparator | All subjects will be randomized to receive oseltamivir placebo(75mg each day during the first five days) and suraxavir marboxil placebo (40mg on the first day). Receives: Drug: Oseltamivir Placebo; Drug: Suraxavir marboxil placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of room contacts who develop clinical influenza within 5 days, with a virus subtype consistent with that of the index case.
The proportion of room contacts who develop clinical influenza* within 5 days, with a virus subtype consistent with that of the index case.
*Clinical influenza is defined as a positive influenza virus detection by Rapid Antigen Test (RAT) or Nucleic Acid Amplification Test (NAAT), accompanied by at least one respiratory symptom (fever or chills, muscle or joint pain, headache, fatigue) and at least onesystemic symptom (cough, nasal congestion, sore throat).
Measured: within 5 days
Secondary outcomes (3)
The proportion of room contacts who develop clinical influenza (as defined above) within 10 days
The proportion of room contacts who develop clinical influenza (as defined above) within 10 days, with a virus subtype consistent with that of the index case.
Measured: within 10 days
The proportion of room contacts with laboratory-confirmed influenza within 5 days
The proportion of room contacts with laboratory-confirmed influenza (defined as a positive influenza virus RAT or NAAT result, regardless of symptoms) within 5 days, with a virus subtype consistent with that of the index case.
Measured: Within 5 days
The incidence of post-treatment changes in the influenza virus sequence
Among room contacts who become infected with influenza virus within 10 days, the incidence of post-treatment changes in the influenza virus sequence (based on viral sequence analysis). This includes the incidence of events such as the I38T amino acid substitution, the H275Y amino acid substitution, and other emerging amino acid substitutions in the PA and NA sequences.
Measured: Within 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start28 Nov 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion6 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Cao, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236814
- Sponsor's protocol ID
- Sur-Ose-Hospital-Prophylaxis
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suraxavir Marboxil And Oseltamivir for Influenza Prophylaxis Under a Hospital-based Setting
- ClinicalTrials.gov ID
- NCT07236814
- Acronym / sponsor ID
- Sur-Ose-Hospital-Prophylaxis
- Conditions
- Influenza
- Keywords
- influenza, suraxavir marboxil, oseltamivir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 6 Mar 2027 (estimated)
- First posted
- 19 Nov 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 evaluate the efficacy of antiviral prophylaxis in preventing in-hospital influenza transmission. We will enroll hospitalized patients with confirmed influenza (index cases) and their uninfected roommates (room contacts). These room contacts will be randomized in a 1:1:1 ratio to one of three prophylactic groups: placebo, suraxavir marboxil, or oseltamivir. The primary outcome will be the rate of influenza infection among the room contacts, which will be monitored to determine the effectiveness of the interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oseltamivir Arm | Experimental | Drug: Oseltamivir, Drug: Suraxavir marboxil placeboAll subjects will be randomized to receive suraxavir marboxil placebo (40mg on the first day) and oseltamivir (75mg each day during the first five days). |
| suraxavir marboxil | Experimental | Drug: Suraxavir marboxil, Drug: OseltamivirAll subjects will be randomized to receive oseltamivir placebo(75mg each day during the first five days) and suraxavir marboxil (40mg on the first day). |
| Control Arm | Placebo comparator | Drug: Oseltamivir Placebo, Drug: Suraxavir marboxil placeboAll subjects will be randomized to receive oseltamivir placebo(75mg each day during the first five days) and suraxavir marboxil placebo (40mg on the first day). |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Suraxavir marboxilSuraxavir marboxil (40mg on the first day) | Drug | suraxavir marboxil |
| Oseltamivir PlaceboOseltamivir placebo(75mg each day during the first five days) | Drug | Control Arm |
| OseltamivirOseltamivir (75mg each day during the first five days) | Drug | Oseltamivir Arm, suraxavir marboxil |
| Suraxavir marboxil placeboSuraxavir marboxil placebo (40mg on the first day). | Drug | Control Arm, Oseltamivir Arm |
Primary outcome
The proportion of room contacts who develop clinical influenza within 5 days, with a virus subtype consistent with that of the index case.
Time frame: within 5 days
The proportion of room contacts who develop clinical influenza* within 5 days, with a virus subtype consistent with that of the index case. *Clinical influenza is defined as a positive influenza virus detection by Rapid Antigen Test (RAT) or Nucleic Acid Amplification Test (NAAT), accompanied by at least one respiratory symptom (fever or chills, muscle or joint pain, headache, fatigue) and at least onesystemic symptom (cough, nasal congestion, sore throat).
3 secondary outcomes
The proportion of room contacts who develop clinical influenza (as defined above) within 10 days
Time frame: within 10 days
The proportion of room contacts with laboratory-confirmed influenza within 5 days
Time frame: Within 5 days
The incidence of post-treatment changes in the influenza virus sequence
Time frame: Within 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 23 Mar 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Suraxavir marboxil and Oseltamivir in people with Influenza, run by Capital Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The proportion of room contacts who develop clinical influenza within 5 days, with a virus subtype consistent with that of the index case. (time frame: within 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2026.