Suraxavir Marboxil And Oseltamivir for Influenza Prophylaxis Under a Hospital-based Setting
ConditionInfluenza
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorCapital Medical University
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Suraxavir marboxil
DrugSuraxavir marboxil (40mg on the first day)
Oseltamivir Placebo
DrugOseltamivir placebo(75mg each day during the first five days)
Oseltamivir
DrugOseltamivir (75mg each day during the first five days)
Suraxavir marboxil placebo
DrugSuraxavir marboxil placebo (40mg on the first day).
Treatment groups
384 Participants
are divided into 3 treatment groupsGroup A: Oseltamivir ArmExperimental treatment 2 interventions
Group B: suraxavir marboxilExperimental treatment 2 interventions
Group C: Control ArmPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
within 5 daysSecondary outcomes
1
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.
Time frame
within 10 days2
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.
Time frame
Within 5 days3
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.
Time frame
Within 10 daysSponsors and contacts
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Source ClinicalTrials.gov