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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
GP681 tablet
GP681 Simulant
Sponsored by
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The First Affiliated Hospital of Nanchang University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

GP681 tablet 40mg

GP681 tablet 20mg

Placebo group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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) .

Secondary Outcome Measures

Full Information

First Posted
January 27, 2021
Last Updated
July 23, 2022
Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04736758
Brief Title
A Clinical Study on the Safety and Efficacy of GP681 Tablets in the Treatment of Uncomplicated Acute Influenza
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 8, 2021 (Actual)
Primary Completion Date
December 18, 2021 (Actual)
Study Completion Date
December 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GP681 tablet 40mg
Arm Type
Experimental
Arm Description
Patients in the GP681 tablet 40mg group is treated with GP681 tablet 40mg orally once with 240mL water.
Arm Title
GP681 tablet 20mg
Arm Type
Experimental
Arm Description
Patients in the GP681 tablet 40mg group is treated with GP681 tablet 20mg orally once with 240mL water.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Patients in the Placebo group is treated with GP681 Simulant orally once with 240mL water.
Intervention Type
Drug
Intervention Name(s)
GP681 tablet
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
GP681 Simulant
Intervention Description
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.
Primary Outcome Measure Information:
Title
time to alleviation of influenza symptoms
Description
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) .
Time Frame
Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin Cao, phd
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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