Phase III Study Comparing GP681 Tablets to Placebo for Preventing Influenza After Exposure in Adults and Teens

What this Trial Is About

Researchers are evaluating the effectiveness and safety of GP681 tablets compared to a placebo for preventing influenza infection after exposure. The study focuses on households where the first patient is confirmed to have influenza and where other household members have not received an influenza vaccine in the past six months and do not show signs of infection. This Phase III trial aims to understand if GP681 can reduce the spread of influenza within these households during the influenza season. Participants are divided randomly into two groups one group receives a single oral dose of GP681 tablets 40mg and the other receives a matching placebo. The main study period lasts up to 10 days during which multiple respiratory swabs are taken from household contacts to detect influenza virus infection. Symptoms are also monitored closely during this time to assess the presence and severity of influenza. Participants will undergo symptom assessments and respiratory swabs through Day 10 to monitor infection status and symptom severity. Researchers track the proportion of household members who become infected and develop moderate to severe symptoms, as well as the timing of symptom onset and infection. Safety and adherence to study procedures, including maintaining health diaries, are also monitored throughout the study duration.

Study to Assess the Efficacy and Safety of GP681 Versus Placebo for Postexposure Prophylaxis Against Influenza