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

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 Overview

• Status: Recruiting
• Conditions: Influenza
• Intervention / Treatment: Drug: Oseltamivir; Drug: Suraxavir marboxil placebo; Drug: Suraxavir marboxil; Drug: Oseltamivir Placebo

• Study Type: Interventional
• Enrollment (Estimated): 384
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yeming Wang, Ph.D.; Phone Number: +86 84206264; Email: wwyymm_love@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Bin Cao; Email: caobin_ben@163.com
    • Beijing, Beijing Municipality, China, 100029
      • Not yet recruiting
      • China-Japan Friendship hospital, Beijing, Beijing
      • Contact: Bin Cao, Ph.D; Phone Number: 8610-84206264; Email: caobin_ben@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oseltamivir Arm; 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; Oseltamivir (75mg each day during the first five days); Drug: Suraxavir marboxil placebo; Suraxavir marboxil placebo (40mg on the first day).
Experimental: suraxavir marboxil; 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: Oseltamivir; Oseltamivir (75mg each day during the first five days); Drug: Suraxavir marboxil; Suraxavir marboxil (40mg on the first day)
Placebo Comparator: Control Arm; 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: Suraxavir marboxil placebo; Suraxavir marboxil placebo (40mg on the first day).; Drug: Oseltamivir Placebo; Oseltamivir placebo(75mg each day during the first five days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Within 10 days

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 6, 2027

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: November 15, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: influenza; oseltamivir; suraxavir marboxil
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human; Organic Chemicals; Hydrocarbons; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Amides; Acetamides; Oseltamivir
• Other Study ID Numbers: Sur-Ose-Hospital-Prophylaxis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No