Actively Recruiting
Study to Assess the Efficacy and Safety of GP681 Versus Placebo for Postexposure Prophylaxis Against Influenza
Led by Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Updated on 2024-12-05
748
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Assess the Efficacy and Safety of GP681 Versus Placebo for Postexposure Prophylaxis Against Influenza
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 2 years or older at the time of signing informed consent
- First patient in a household with confirmed influenza virus infection by positive rapid antigen test or PCR during influenza season
- Fever of 37.3°C or higher at predose or more than 4 hours after antipyretic use
- Onset of fever within 48 hours at informed consent
- Living in a household where all contacts meet key inclusion criteria
- Willing and able to provide informed consent and comply with study procedures
- Household contacts aged 12 years or older at informed consent
- Household contacts able to provide informed consent within 24 hours of index patient consent
- Household contacts living with index patient for 3 months or more prior to consent
- Household contacts negative for influenza virus by antigen test or PCR
- Household contacts with body temperature below 37.3°C at screening
- Household contacts without influenza-like symptoms at screening
- Household contacts have not received influenza vaccine within 6 months prior to screening
- Willing and able to provide informed consent and comply with study procedures including diary records
You will not qualify if you...
- History of allergic reactions to GP681 or its ingredients
- Household members other than index patient diagnosed or strongly suspected of influenza in past 12 weeks
- Concurrent bacterial or other viral infections requiring systemic antimicrobial or antiviral therapy at predose
- Unable to live with index patient from screening until Day 10
- Known history of swallowing difficulties or gastrointestinal diseases affecting drug absorption
- Underlying diseases requiring systemic treatment with antipyretics, corticosteroids, immunosuppressive agents
- HIV infection
- Severe underlying diseases (Grade 3 or higher CTCAE ver. 5)
- Treatment with anti-influenza drugs within 2 weeks before screening
- History of alcohol or drug abuse exceeding specified amounts
- Pregnant or breastfeeding women or positive pregnancy test at predose, except postmenopausal or surgically sterile women
- Received investigational agents or devices within 30 days prior to screening
- Investigator judgment of unsuitability or unqualification for the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shulan (Hang Zhou) Hospital
Hanzhou, China
Actively Recruiting
Research Team
S
Siyuan Xi
CONTACT
B
Bin Cao, phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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