Suraxavir Marboxil And Oseltamivir for Influenza Prophylaxis Under a Hospital-based Setting
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Capital Medical University
- Enrollment
- 384
- Locations
- 2
- Primary Endpoint
- The proportion of room contacts who develop clinical influenza within 5 days, with a virus subtype consistent with that of the index case.
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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.
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.
Arms & Interventions
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).
Intervention: Oseltamivir (Drug)
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).
Intervention: Suraxavir marboxil placebo (Drug)
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).
Intervention: Suraxavir marboxil (Drug)
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).
Intervention: Oseltamivir (Drug)
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).
Intervention: Oseltamivir Placebo (Drug)
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).
Intervention: Suraxavir marboxil placebo (Drug)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- 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)
Investigators
Bin Cao
Professor
Capital Medical University