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

Sponsor

Jiangxi Qingfeng Pharmaceutical Co. Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT04736758

Collaborator

(none)

216

Enrollment

Location

Arms

11.3

Actual Duration (Months)

19.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Drug: GP681 tablet Drug: GP681 Simulant	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

216 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 8, 2021

Actual Primary Completion Date :

Dec 18, 2021

Actual Study Completion Date :

Dec 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GP681 tablet 40mg Patients in the GP681 tablet 40mg group is treated with GP681 tablet 40mg orally once with 240mL water.	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.
Experimental: GP681 tablet 20mg Patients in the GP681 tablet 40mg group is treated with GP681 tablet 20mg orally once with 240mL water.	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.
Placebo Comparator: Placebo group Patients in the Placebo group is treated with GP681 Simulant orally once with 240mL water.	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.

Arm

Intervention/Treatment

Experimental: GP681 tablet 40mg

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

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.

Experimental: GP681 tablet 20mg

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

Drug: GP681 tablet

Placebo Comparator: Placebo group

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

Drug: GP681 Simulant

Outcome Measures

Primary Outcome Measures

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) .

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China	330006

Sponsors and Collaborators

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Investigators

Principal Investigator: Bin Cao, phd, China-Japan Friendship Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

ClinicalTrials.gov Identifier:

NCT04736758

Other Study ID Numbers:

GP681-202002

First Posted:

Feb 3, 2021

Last Update Posted:

Jul 26, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Influenza, Human

Study Results

No Results Posted as of Jul 26, 2022