Index patients who are infected with influenza virus (Q-PCR positive) can be treated with anti-influenza drugs if their influenza symptoms onset was within 48 hours of screening. Their eligible households will be randomized to either GP681 tablets or placebo if at least 1 household contacts have not received influenza vaccine with 6 months of screening and if all household contacts screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from household contacts up to Day 10, and through the assessment of symptoms.
Male or female patients aged≥2 years at the time of signing the informed consent form.
Positive Influenza rapid antigen test or Polymerase chain reaction (PCR), and;
Fever (axillary temperature ≥37.3℃) in the predose examinations or > 4 hours after dosing of antipyretics if they were taken.
Patients with onset of fever within 48 hours or less at informed consent.
History of allergic reactions attributed to GP681 or any of the ingredients of its formulation.
Subjects with household members other than the index patient that was diagnosed with or strongly suspected to have influenza in the past 12 weeks.
subjects with concurrent bacterial or other virus infections requiring systemic antimicrobial and/or antiviral therapy at the pre-dose examinations.
Subjects who are unable to live with the index patient from Screening until Day 10.
Parallel
GP681 40mg
Drug2X20mg tablets taken orally
GP681 Simulant
DrugPlacebo tablets matching GP681 40mg
Proportion of household members who are infected with influenza virus (Q-PCR positive), and present with fever and at least one influenza symptom with severity of moderate or severe in the period from Day 1 to Day 10.
Defined as the proportion of household members having body temperature (axillary)≥37.3°C, having symptom of influenza (respiratory symptoms or systemic symptoms) with a severity of "2, Moderate" or "3, Severe" assessed in the subject diary, and influenza virus positive assessed by Q-PCR.
Proportion of household members who are infected with influenza virus (Q-PCR positive), and present with fever or at least one influenza symptom with severity of moderate or severe in the period from Day 1 to Day 10.
Defined as the proportion of household members having body temperature (axillary)≥37.3°C, or having symptom of influenza (respiratory symptoms or systemic symptoms) with a severity of "2, Moderate" or "3, Severe" assessed in the subject diary, and influenza virus positive assessed by Q-PCR.
Proportion of household members with influenza virus infection in the period from Day 1 to Day 10
Defined as the proportion of subjects having influenza virus positive assessed by RT-PCR regardless of body temperature or influenza symptoms.
Time from study treatment to the time when fever, at least one influenza symptom with severity of moderate or severe, and influenza virus infection were observed.
Defined as the later timepoint of the following (1) and (2): 1. Timepoint when body temperature (axillary) rises first to " 37.3°C 2. Timepoint when an influenza symptom was first assessed as"2, Moderate" or "3, Severe" in the subject diary. If a household member does not have a body temperature (axillary) of "37.3°C or influenza symptom was not assessed as"2, Moderate" or "3, Severe" in the period from Day 1 to Day 10, the subject will be handled as a censored case.
Time from study treatment to the time when fever or at least one influenza symptom (respiratory symptom or systemic symptom), and influenza virus infection are observed.
Defined as the timepoint of the following (1) and (2), whichever is earlier: 1. Timepoint when body temperature (axillary) rises first to " 37.3°C 2. Timepoint when an influenza symptom was first assessed as"2, Moderate" or "3, Severe" in the subject diary. If a subject does not have a body temperature (axillary) of "37.5°C and influenza symptoms (respiratory symptoms and systemic symptoms) were not assessed as 2, Moderate or 3, Severe in the period from Day 1 to Day 10, the subject will be handled as a censored case.
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