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

NCT ID: NCT06574503

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 748 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2027-12-30

Brief 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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GP681 tablet 40mg

atients in the GP681 tablet 40mg group will receive a single oral dose of GP681 tablet 40mg with water.

Group Type: EXPERIMENTAL

GP681 40mg

Intervention Type: DRUG

2X20mg tablets taken orally

Placebo group

Patients in the Placebo group will receive a single oral dose of GP681 Simulant 40mg with water.

Group Type: PLACEBO_COMPARATOR

GP681 Simulant

Intervention Type: DRUG

Placebo tablets matching GP681 40mg

Interventions

GP681 40mg

2X20mg tablets taken orally

Intervention Type: DRUG

GP681 Simulant

Placebo tablets matching GP681 40mg

Intervention Type: DRUG

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.

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shulan (Hang Zhou) Hospital

Hanzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Siyuan Xi

Role: CONTACT

Phone: 84206250

Email: ZRYHYYGCPEC@126.com

Bin Cao, phd

Role: CONTACT

Phone: 13911318339

Email: caobin_ben@163.com

Facility Contacts

Hainv Gao

Role: primary

Other Identifiers

GP681-202403

Identifier Type: -

Identifier Source: org_study_id