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RECRUITING
NCT06574503
PHASE3

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

Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

748

Start Date

2024-12-01

Completion Date

2027-12-30

Last Updated

2024-12-05

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

GP681 40mg

2X20mg tablets taken orally

DRUG

GP681 Simulant

Placebo tablets matching GP681 40mg

Locations (1)

Shulan (Hang Zhou) Hospital

Hanzhou, China