Phase III Study of GP681 Tablets Versus Placebo for Treating Influenza in Patients Aged 12 and Older at High Risk of Complications

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and how the body processes a single oral dose of GP681 compared to a placebo in people aged 12 and older who have influenza and are at high risk for complications. This Phase III clinical trial aims to better understand the impact of GP681 on influenza symptoms and viral activity in this vulnerable population. Participants will be randomly assigned to receive either a 40mg oral dose of GP681 tablets or a matching placebo tablet. This is a double-blind, placebo-controlled study, meaning neither the participants nor the researchers know who receives the actual drug or placebo. The study will measure outcomes such as the time it takes for influenza symptoms to improve and changes in viral RNA levels over a 15-day period. During the study, participants will be monitored closely with symptom evaluations, virus testing at multiple time points, and assessments of fever resolution and influenza-related complications. They will keep health diaries and attend study visits for up to 15 days to track their recovery and any side effects. Safety and efficacy data will be collected throughout this period to assess the impact of GP681 compared with placebo.

Study of GP681 Tablets Compared With Placebo in Patients With Influenza at High Risk of Influenza Complications