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

Qingfeng Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Drug: GP681 Simulant; Drug: GP681 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04736758

GP681-202002

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 3 patient groups, including a placebo group

GP681 tablet 40mg

Experimental group

Description:

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

Treatment:

Drug: GP681 tablet

GP681 tablet 20mg

Experimental group

Description:

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

Treatment:

Drug: GP681 tablet

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: GP681 Simulant