This study is a randomized, double-blind, placebo-controlled phase III clinical trial. The trial participants include index participants (IP) and household contacts (HHC). A total of 536 index participants (the first person in the household diagnosed with influenza) and 858 household contacts (family members living with the index participant) are planned to be enrolled. After the index participants and their household contacts have signed informed consent form and passed screening eligibility, randomization will be performed at the household level in a 1:1 ratio, stratifying by the time from onset of the index participant's initial influenza symptoms to signing of informed consent form (\<24 hours, ≥24 hours), index participant's viral subtype (influenza A, influenza B), and household contact's age (\<12 years, ≥12 years). Household contacts will be assigned to either the Sebaloxavir marboxil group or the placebo group. The study objective is to compare the prophylactic efficacy and safety of Sebaloxavir marboxil tablets/oral suspension versus placebo in household contacts (HHCs).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
858
Dosing Regimen for Household Contacts: Sebaloxavir marboxil tablets/oral suspension is administered based on age as follows: * 18 years: Single dose, Sebaloxavir marboxil tablets: 2 tablets; * 12 years and \<18 years: Single dose, Sebaloxavir marboxil tablets: 1 tablet; * 2 years and \<12 years: Single dose, Sebaloxavir marboxil oral suspension, administered according to body weight.
Dosing Regimen for Household Contacts: Household contacts will receive the placebo of Sebaloxavir marboxil tablets/oral suspension based on age as follows: * 18 years: Single dose, placebo of Sebaloxavir marboxil tablets: 2 tablets; * 12 years and \<18 years: Single dose, placebo of Sebaloxavir marboxil tablets: 1 tablet; * 2 years and \<12 years: Single dose, placebo of Sebaloxavir marboxil oral suspension, administered according to body weight.
China Japan friendship hospital
Beijing, Beijing Municipality, China
The percentage of household contacts (HHCs) with PCR-positive influenza virus infection accompanied by fever (axillary temperature ≥37.5°C) and at least one additional influenza symptom (e.g., nasal congestion, sore throat, cough) after dosing.
Time frame: From day1 up to day10
Percentage of HHCs with PCR-positive influenza virus infection but no influenza symptoms after dosing.
Time frame: From day1 up to day10
Percentage of HHCs with PCR-positive influenza virus infection accompanied by fever (axillary temperature ≥37.5°C) or at least one other influenza symptom after dosing.
Time frame: From day1 up to day10
Time from dosing to PCR-positive influenza virus infection accompanied by fever or at least one other influenza symptom after dosing.
Time frame: From day1 up to day10
Time from dosing to meeting the primary endpoint criteria (influenza virus infection accompanied by fever [axillary temperature ≥37.5°C] and at least one other influenza symptom).
Time frame: From day1 up to day10
Percentage of households with at least one HHC achieving the primary endpoint criteria after dosing, relative to all households.
Time frame: From day1 up to day10
Incidence of all adverse events (AEs) and serious adverse events (SAEs)
Time frame: Time Frame: From day1 up to day15
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