Study to Assess the Efficacy and Safety of GP681 Versus Placebo for Postexposure Prophylaxis Against Influenza
Recruiting
Phase 3
Interventional Study
Influenza
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 12 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 748 (estimated)
- Sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Index patients(IPs)
1. Male or female patients aged≥2 years at the time of signing the informed consent form.
2. The first patient in a household with a diagnosis of influenza virus infection confirmed by all of the following in the influenza season:
3. Positive Influenza rapid…
Contacts