NCT06574503

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

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Efficacy and Safety Study of GP681 Tablets for Post-exposure Prophylaxis Against Influenza in Adults and Adolescents

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 748 (estimated)
• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	GP681 40mg	2X20mg tablets taken orally
DRUG	GP681 Simulant	Placebo tablets matching GP681 40mg

Timeline

• Start date: 2024-12-01
• Primary completion: 2027-07-30
• Completion: 2027-12-30
• First posted: 2024-08-28
• Last updated: 2024-12-05

Locations

1 site across 1 country: China