Study to Assess the Efficacy and Safety of GP681 Versus Placebo for Postexposure Prophylaxis Against Influenza
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: Index patients(IPs) 1. Male or female patients aged≥2 years at the time of signing the informed consent form. 2. The first patient in a household with a diagnosis of influenza virus infection confirmed by all of the following in the influenza season: 3. Positive Influenza rapid antigen test or Polymerase chain reaction (PCR), and; 4. Fever (axillary temperature ≥37.3℃) in the predose examinations or \> 4 hours after dosing of antipyretics if they were taken. 5. Patients with onset of fever within 48 hours or less at informed consent. 6. Patients live in a household where all household contacts are expected to meet the key household contacts inclusion criteria (criteria 2, 3, \& 4). 7. Patients and/or their guardian who are willing to provide written informed consent and consent to participate in the study, able to understand the study and comply with all study procedures. Household contacts of index patients: 1. Male or female patients aged≥12 years at the time of s