RECRUITINGPhase 3INTERVENTIONAL
Suraxavir Marboxil And Oseltamivir for Influenza Prophylaxis Under a Hospital-based Setting
About This Trial
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.
Who May Be Eligible (Plain English)
1.Who May Qualify:
(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 willing to sign a consent form 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 willing to sign a consent form 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.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Suraxavir marboxil
Suraxavir marboxil (40mg on the first day)
DRUG
Oseltamivir Placebo
Oseltamivir placebo(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).
Locations (2)
China-Japan Friendship hospital, Beijing, Beijing
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China