Assessing GP681 for preventing influenza after exposure

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

This study tests if a new flu medication called GP681 can help prevent influenza in people who have been exposed to someone with the virus.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 748 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. (Industry-sponsored)
• Locations: 1 site (Hanzhou)
• Trial ID: NCT06574503 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of GP681, an anti-influenza medication, compared to a placebo for post-exposure prophylaxis against influenza. Households with an index patient diagnosed with influenza will be randomized to receive either GP681 or a placebo, provided that household contacts have not been vaccinated against influenza in the past six months and are not currently infected. The study will assess the outcomes based on respiratory swabs and symptom evaluations over a period of ten days.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 2 years and older who live in households with a confirmed influenza case and have not been vaccinated against influenza in the last six months.

Not a fit: Patients who have been vaccinated against influenza within the last six months or are currently infected with the virus will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of influenza among exposed household contacts.

How similar studies have performed: Previous studies have shown promise in using antiviral medications for post-exposure prophylaxis against influenza, indicating that this approach is not entirely novel but still holds potential for further validation.

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 antigen test or Polymerase chain reaction (PCR), and;
4. Fever (axillary temperature ≥37.3℃) in the predose examinations or \> 4 hours after dosing of antipyretics if they were taken.
5. Patients with onset of fever within 48 hours or less at informed consent.
6. Patients live in a household where all household contacts are expected to meet the key household contacts inclusion criteria (criteria 2, 3, \& 4).
7. 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.

Household contacts of index patients:

1. Male or female patients aged≥12 years at the time of signing the informed consent form.
2. Household contacts who are able to provide informed consent within 24 hours or less from informed consent in index patients.
3. Subjects who had lived with the index patient for 3 months or more prior to informed consent.
4. Subjects who meet all of the following criteria and are judged not to have influenza virus infection by the investigator.
5. Negative Influenza rapid antigen test or Polymerase chain reaction (PCR), and;
6. Subjects who have a body temperature (axillary) \< 37.3°C at Screening, and;
7. Subjects who have no influenza like symptoms (cough, sore throat, headache, nasal discharge/nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) at Screening.
8. Household contacts intended for full study have not received influenza vaccine within 6 months prior to screening;
9. Subjects 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, including patient health diary records.

Exclusion Criteria:

Household contacts of index patients:

1. History of allergic reactions attributed to GP681 or any of the ingredients of its formulation.
2. Subjects with household members other than the index patient that was diagnosed with or strongly suspected to have influenza in the past 12 weeks.
3. subjects with concurrent bacterial or other virus infections requiring systemic antimicrobial and/or antiviral therapy at the pre-dose examinations.
4. Subjects who are unable to live with the index patient from Screening until Day 10.
5. 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.).
6. Subjects who have any underlying diseases requiring systemic , treatment of antipyretics/analgesics, corticosteroids, or immunosuppressive agents.
7. Subjects with human immunodeficiency virus \[HIV\] infection.
8. Subjects with severe (Grade 3 or higher of Common Terminology Criteria for Adverse Events \[CTCAE\] ver. 5) underlying diseases.
9. Treatment with anti-influenza virus drugs (oseltamivir, zanamivir, peramivir, favipiravir, abidol, baloxavir marboxil, amantadine, or rimantadine) within 2 weeks before screening.
10. Known history of alcohol abuse (Average weekly intake of alcohol is more than 14 units alcohol (1 units ≈ 360 mL beer, or 45 mL spirits with 40% content, or 150 mL wine) or drug abuse at screening;
11. Women who are pregnant, breastfeeding, or have a positive pregnancy test at the predose examinations. The following female patients who have documentation of either a or below do not need to undergo a pregnancy test at the predose examinations:

    1. Postmenopausal women (defined as cessation of regular menstrual periods for 2 years or more and aged more than 50 years old)
    2. Women who are surgically sterile by hysterectomy, bilateral oophorectomy, or tubal ligation
12. Has received any investigational agents or devices for any indication within 30 days prior to Screening.
13. Subjects who, in the opinion of the Investigator, may not be qualified or suitable for the study.

Where this trial is running

Hanzhou

• Shulan (Hang Zhou) Hospital — Hanzhou, China (Recruiting)

Study contacts

• Study coordinator: Siyuan Xi

Conditions Influenza