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

NCT04736758 | Completed Phase 2

• 1 other identifier: GP681-202002
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• time to alleviation of influenza symptoms

  Defined as the time from the start of treatment until the patient's body temperature returns to normal and all 7 flu symptoms (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, fatigue) have alleviated (scoring 0 or 1 point) .

  Day 15

Study Arms (3)

GP681 tablet 40mg

EXPERIMENTAL

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

Drug: GP681 tablet

GP681 tablet 20mg

EXPERIMENTAL

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

Drug: GP681 tablet

Placebo group

PLACEBO COMPARATOR

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

Drug: GP681 Simulant

Interventions

GP681 tablet 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; GP681 tablet 40mg

GP681 Simulant 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Systemic symptoms: headache, fever or chills, muscle or joint aches, fatigue;
• Respiratory system symptoms: cough, sore throat, nasal congestion.
• Time of disease symptoms ≤48h

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangxi Qingfeng Pharmaceutical Co. Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Related Publications (1)

• 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.

  PMID: 39870350 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Officials

• Bin Cao, phd

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 3, 2021
• Study Start: January 8, 2021
• Primary Completion: December 18, 2021
• Study Completion: December 18, 2021
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)