Clinical Trial

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

Recruiting Phase 3
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-08-25.
Status change: Not Yet Recruiting → Recruiting 2024-12-03
Trial Details
NCT Number NCT06574503
Lead Sponsor Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Conditions Influenza
Enrollment 748 participants
Start Date 2024-12-01
Primary Completion 2027-07-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2024-12-05