RecruitingPhase 3NCT06574503

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


Sponsor

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Enrollment

748 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called GP681 40mg and a drug called GP681 Simulant for people with influenza. The study is currently recruiting participants at 1 location. People eligible for this study include aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGP681 40mg

2X20mg tablets taken orally

DRUGGP681 Simulant

Placebo tablets matching GP681 40mg


Locations(1)

Shulan (Hang Zhou) Hospital

Hanzhou, China

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NCT06574503


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