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.