A Clinical Study on the Safety and Efficacy of GP681 Tablets in the Treatment of Uncomplicated Acute Influenza

NCT ID: NCT04736758

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-08
• Study Completion Date: 2021-12-18

Brief Summary

Analyse the time of flu symptom relief in adults with uncomplicated acute influenza,to evaluate the antiviral effects of high and low doses of GP681 tablets, and explore the optimal dose for phase III clinical trials.

Conditions

Influenza

Study Design

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

Study Groups

GP681 tablet 40mg

Patients in the GP681 tablet 40mg group is treated with GP681 tablet 40mg orally once with 240mL water.

Group Type: EXPERIMENTAL

GP681 tablet

Intervention Type: DRUG

influenza subjects is randomized 1:1:1 into GP681 tablet 40mg group,GP681 tablet 20mg group and Placebo group,with 72 patients in each group.subjects is given with GP681 tablet or GP681 Simulant only once to treat influenza.

GP681 tablet 20mg

Patients in the GP681 tablet 40mg group is treated with GP681 tablet 20mg orally once with 240mL water.

Group Type: EXPERIMENTAL

GP681 tablet

Intervention Type: DRUG

influenza subjects is randomized 1:1:1 into GP681 tablet 40mg group,GP681 tablet 20mg group and Placebo group,with 72 patients in each group.subjects is given with GP681 tablet or GP681 Simulant only once to treat influenza.

Placebo group

Patients in the Placebo group is treated with GP681 Simulant orally once with 240mL water.

Group Type: PLACEBO_COMPARATOR

GP681 Simulant

Intervention Type: DRUG

influenza subjects is randomized 1:1:1 into GP681 tablet 40mg group,GP681 tablet 20mg group and Placebo group,with 72 patients in each group.subjects is given with GP681 tablet or GP681 Simulant only once to treat influenza.

Interventions

GP681 tablet

influenza subjects is randomized 1:1:1 into GP681 tablet 40mg group,GP681 tablet 20mg group and Placebo group,with 72 patients in each group.subjects is given with GP681 tablet or GP681 Simulant only once to treat influenza.

Intervention Type: DRUG

GP681 Simulant

influenza subjects is randomized 1:1:1 into GP681 tablet 40mg group,GP681 tablet 20mg group and Placebo group,with 72 patients in each group.subjects is given with GP681 tablet or GP681 Simulant only once to treat influenza.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Positive Influenza rapid antigen test;
• Fever (axillary temperature ≥37.3℃) or the axillary temperature ≥37.3℃ after taking the medicine for more than 4 hours;
• At least one systemic symptom and respiratory symptom related to a moderate or above influenza virus infection:

1. Systemic symptoms: headache, fever or chills, muscle or joint aches, fatigue;

2. Respiratory system symptoms: cough, sore throat, nasal congestion.

• Time of disease symptoms ≤48h

Exclusion Criteria

• Diagnosed as severe influenza patient ;
• 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.);
• Have used anti-influenza virus drugs (oseltamivir, zanamivir, peramivir, favipiravir, abidol, baloxavir dipivoxil, amantadine, or diamond) within 2 weeks before screening Ethylamine, etc.);
• Acute respiratory infections, otitis media, sinusitis or other infectious diseases such as bronchitis, pneumonia, tuberculosis, etc. occurred within 2 weeks before screening, and are in the acute stage;
• Patients who also suffer from bacterial or viral infections and need systemic antibacterial or antiviral therapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bin Cao, phd

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Locations

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Countries

China

References

Wang Y, Wang H, Liu D, Ding Y, Zhang M, Xiao Z, Jiang X, Wu Y, Zhang W, Sun S, Chen X, Zhang W, Tang Y, Jiang M, Yang G, Jia W, Wang X, Tong J, Suo L, Yu Y, Yan X, Li Z, Li X, Cao B. Efficacy and safety of single-dose suraxavir marboxil tablet in the treatment of acute uncomplicated influenza in adults: a multi-centre, randomized, double-blind, placebo-controlled phase 2 clinical trial. Clin Microbiol Infect. 2025 May;31(5):861-868. doi: 10.1016/j.cmi.2025.01.025. Epub 2025 Jan 25.

Reference Type: DERIVED

PMID: 39870350 (View on PubMed)

Other Identifiers

GP681-202002

Identifier Type: -

Identifier Source: org_study_id