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

Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Study ID
NCT06574503
Phase
PHASE3
Status
Recruiting
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Conditions

  • Influenza

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • GP681 40mg — DRUG
    2X20mg tablets taken orally
  • GP681 Simulant — DRUG
    Placebo tablets matching GP681 40mg

Study Details

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.

Key Dates

First listed
Aug 28, 2024
Start date
Dec 1, 2024
Status verified
Dec 2024
Primary completion
Jul 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
748 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GP681 tablet 40mg
    atients in the GP681 tablet 40mg group will receive a single oral dose of GP681 tablet 40mg with water.
  • Placebo Comparator: Placebo group
    Patients in the Placebo group will receive a single oral dose of GP681 Simulant 40mg with water.

Primary Outcome Measure

Proportion of household members who are infected with influenza virus (Q-PCR positive), and present with fever and at least one influenza symptom with severity of moderate or severe in the period from Day 1 to Day 10. [ Time Frame: up to Day 10 ]

Central Contacts

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