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

Sponsor
Capital Medical University
Study ID
NCT07236814
Phase
PHASE3
Status
Recruiting
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Conditions

  • Influenza

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Suraxavir marboxil — DRUG
    Suraxavir marboxil (40mg on the first day)
  • Oseltamivir Placebo — DRUG
    Oseltamivir placebo(75mg each day during the first five days)
  • Oseltamivir — DRUG
    Oseltamivir (75mg each day during the first five days)
  • Suraxavir marboxil placebo — DRUG
    Suraxavir marboxil placebo (40mg on the first day).

Study Details

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.

Key Dates

First listed
Nov 19, 2025
Start date
Nov 28, 2025
Status verified
Nov 2025
Primary completion
Mar 1, 2027
Completion
Mar 6, 2027

Study Design

Enrollment
384 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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).
  • 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).
  • 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).

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 ]

Central Contacts

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