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

Influenza Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study on the Safety and Efficacy of GP681 Tablets in the Treatment of Uncomplicated Acute Influenza

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04736758
• Other study ID #: GP681-202002
• Status: Completed
• Phase: Phase 2
• Start date: January 8, 2021
• Est. completion date: December 18, 2021

Study information

• Verified date: July 2022
• Source: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: December 18, 2021
• Est. primary completion date: December 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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