Suraxavir Marboxil And Oseltamivir for Influenza Prophylaxis Under a Hospital-based Setting

NCT07236814 | Recruiting Phase 3

• 1 other identifier: Sur-Ose-Hospital-Prophylaxis
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 2

Brief 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). 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

Keywords

influenza; suraxavir marboxil; oseltamivir

Outcome Measures

Primary Outcomes (1)

• 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).

  within 5 days

Secondary Outcomes (3)

• The proportion of room contacts who develop clinical influenza (as defined above) within 10 days

  within 10 days

• The proportion of room contacts with laboratory-confirmed influenza within 5 days

  Within 5 days

• The incidence of post-treatment changes in the influenza virus sequence

  Within 10 days

Study Arms (3)

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).

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).

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).

Drug: Oseltamivir Placebo; Drug: Suraxavir marboxil placebo

Interventions

Suraxavir marboxil DRUG

Suraxavir marboxil (40mg on the first day)

suraxavir marboxil

Oseltamivir Placebo DRUG

Oseltamivir placebo(75mg each day during the first five days)

Control Arm

Oseltamivir DRUG

Oseltamivir (75mg each day during the first five days)

Oseltamivir Arm; suraxavir marboxil

Suraxavir marboxil placebo DRUG

Suraxavir marboxil placebo (40mg on the first day).

Control Arm; Oseltamivir Arm

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (2)

China-Japan Friendship hospital, Beijing, Beijing

Beijing, Beijing Municipality, 100029, China

NOT YET RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Yeming Wang, Ph.D.

CONTACT

+86 84206264; wwyymm_love@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 19, 2025
• Study Start: November 28, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 6, 2027
• Last Updated: March 23, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)