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

Capital Medical University

Status and phase: Not yet enrolling; Phase 3

Conditions: Influenza

Treatments: Drug: Oseltamivir; Drug: Suraxavir marboxil; Drug: Oseltamivir Placebo; Drug: Suraxavir marboxil placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07236814

Sur-Ose-Hospital-Prophylaxis

Details and patient eligibility

About

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.

Enrollment: 384 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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384 participants in 3 patient groups, including a placebo group

Oseltamivir Arm

Experimental group

Description:

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).

Treatment:

Drug: Suraxavir marboxil placebo

Drug: Oseltamivir

suraxavir marboxil

Experimental group

Description:

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).

Treatment:

Drug: Suraxavir marboxil

Drug: Oseltamivir

Control Arm

Placebo Comparator group

Description:

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).

Treatment:

Drug: Suraxavir marboxil placebo

Drug: Oseltamivir Placebo