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

Phase 2

Completed

• Conditions: Influenza
• Interventions: Drug: GP681 tablet; Drug: GP681 Simulant

• Registration Number: NCT04736758
• Lead Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-08
• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-03
• Primary Completion: 2021-12-18
• Study Completion: 2021-12-18
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-23
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GP681 tablet 20mg	GP681 tablet	Patients in the GP681 tablet 40mg group is treated with GP681 tablet 20mg orally once with 240mL water.
GP681 tablet 40mg	GP681 tablet	Patients in the GP681 tablet 40mg group is treated with GP681 tablet 40mg orally once with 240mL water.
Placebo group	GP681 Simulant	Patients in the Placebo group is treated with GP681 Simulant orally once with 240mL water.

Primary Outcome Measures

Name	Time	Method
time to alleviation of influenza symptoms	Day 15	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) .

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China