drugset / Trial / NCT06574503

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

NCT06574503

Phase 3 Recruiting 748 enrolled Jiangxi Qingfeng Pharmaceutical Co. Ltd.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2024-12-01
Primary completion
2027-07-30
Completion
2027-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject GP681 Unknown 40 mg Oral

Indications