Study to Assess the Efficacy and Safety of GP681 Versus Placebo for Postexposure Prophylaxis Agai… (NCT06574503) | Clinical Trial Compass
RecruitingPhase 3
Study to Assess the Efficacy and Safety of GP681 Versus Placebo for Postexposure Prophylaxis Against Influenza
China748 participantsStarted 2024-12-01
Plain-language 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.
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female patients aged≥2 years at the time of signing the informed consent form.
✓. The first patient in a household with a diagnosis of influenza virus infection confirmed by all of the following in the influenza season:
✓. Positive Influenza rapid antigen test or Polymerase chain reaction (PCR), and;
✓. Fever (axillary temperature ≥37.3℃) in the predose examinations or \> 4 hours after dosing of antipyretics if they were taken.
✓. Patients with onset of fever within 48 hours or less at informed consent.
✓. Patients live in a household where all household contacts are expected to meet the key household contacts inclusion criteria (criteria 2, 3, \& 4).
✓. Patients and/or their guardian who are willing to provide written informed consent and consent to participate in the study, able to understand the study and comply with all study procedures.
✓. Male or female patients aged≥12 years at the time of signing the informed consent form.
Exclusion criteria
What they're measuring
1
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.
✕. History of allergic reactions attributed to GP681 or any of the ingredients of its formulation.
✕. Subjects with household members other than the index patient that was diagnosed with or strongly suspected to have influenza in the past 12 weeks.
✕. subjects with concurrent bacterial or other virus infections requiring systemic antimicrobial and/or antiviral therapy at the pre-dose examinations.
✕. Subjects who are unable to live with the index patient from Screening until Day 10.
✕. Known history of dysphagia or any gastrointestinal disease that affects drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, stomach after subtotal resection, etc.).
✕. Subjects who have any underlying diseases requiring systemic , treatment of antipyretics/analgesics, corticosteroids, or immunosuppressive agents.
✕. Subjects with human immunodeficiency virus \[HIV\] infection.
✕. Subjects with severe (Grade 3 or higher of Common Terminology Criteria for Adverse Events \[CTCAE\] ver. 5) underlying diseases.