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).
Index Participants:
Inclusion Criteria:
Exclusion Criteria:
Household contact:
Inclusion Criteria:
1. Aged ≥2 years at the time of randomization, with no gender restriction;
2. Has been living in the same household with the index participant for at least 48 hours at the time of randomization;
3. Is able to reside with the index participant from screening/randomization through Day 10 (must live in the same household with the index participant for at least 7 days);
4. Tests negative by rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR);
5. Meets all of the following criteria and is judged by the investigator to have no influenza virus infection:
6. The HHC is ≥18 years of age, or the HHC is <18 years of age and together with their parent(s)/legal guardian(s) understands and voluntarily signs the informed consent form (ICF), and agrees to comply with all study procedures, including completion of diary cards (the guardian may assist in assessment/completion).
7. The HHC must sign the informed consent form (ICF) within 24 hours after the index participant signs the ICF;
8. The HHC and their partner must agree to practice complete abstinence or use effective contraceptive measures from screening through 3 months after the end of study drug administration.
Exclusion Criteria:
Beijing, Beijing Municipality 100029, China
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