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

NCT06574503 | Recruiting Phase 3

• 1 other identifier: GP681-202403
• Study Type: interventional
• Target: 748
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (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.

  Defined as the proportion of household members having body temperature (axillary)≥37.3°C, having symptom of influenza (respiratory symptoms or systemic symptoms) with a severity of "2, Moderate" or "3, Severe" assessed in the subject diary, and influenza virus positive assessed by Q-PCR.

  up to Day 10

Secondary Outcomes (7)

• Proportion of household members who are infected with influenza virus (Q-PCR positive), and present with fever or at least one influenza symptom with severity of moderate or severe in the period from Day 1 to Day 10.

  up to Day10

• Proportion of household members with influenza virus infection in the period from Day 1 to Day 10

  up to Day10

• Time from study treatment to the time when fever, at least one influenza symptom with severity of moderate or severe, and influenza virus infection were observed.

  up to Day10

• Time from study treatment to the time when fever or at least one influenza symptom (respiratory symptom or systemic symptom), and influenza virus infection are observed.

  up to Day10

• Proportion of asymptomatic influenza-infected (Q-PCR positive) household members in the period from Day 1 to Day 10

  Up to Day 10

Study Arms (2)

GP681 tablet 40mg

EXPERIMENTAL

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

Drug: GP681 40mg

Placebo group

PLACEBO COMPARATOR

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

Drug: GP681 Simulant

Interventions

GP681 40mg DRUG

2X20mg tablets taken orally

GP681 tablet 40mg

GP681 Simulant DRUG

Placebo tablets matching GP681 40mg

Placebo group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Index patients(IPs)
• 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 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:
• Male or female patients aged≥12 years at the time of signing the informed consent form.
• Household contacts who are able to provide informed consent within 24 hours or less from informed consent in index patients.
• Subjects who had lived with the index patient for 3 months or more prior to informed consent.
• Subjects who meet all of the following criteria and are judged not to have influenza virus infection by the investigator.
• Negative Influenza rapid antigen test or Polymerase chain reaction (PCR), and;
• Subjects who have a body temperature (axillary) \< 37.3°C at Screening, and;
• 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.

You may not qualify if:

• Household contacts of index patients:
• 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.
• Treatment with anti-influenza virus drugs (oseltamivir, zanamivir, peramivir, favipiravir, abidol, baloxavir marboxil, amantadine, or rimantadine) within 2 weeks before screening.
• 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;
• 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:
• Postmenopausal women (defined as cessation of regular menstrual periods for 2 years or more and aged more than 50 years old)
• Women who are surgically sterile by hysterectomy, bilateral oophorectomy, or tubal ligation
• Has received any investigational agents or devices for any indication within 30 days prior to Screening.

Sponsors & Collaborators

• Jiangxi Qingfeng Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Shulan (Hang Zhou) Hospital

Hanzhou, China

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Central Study Contacts

Siyuan Xi

CONTACT

84206250; ZRYHYYGCPEC@126.com

Bin Cao, phd

CONTACT

13911318339; caobin_ben@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: August 28, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)