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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04736758

Enrollment

216

Registered

2021-02-03

Start date

2021-01-08

Completion date

2021-12-18

Last updated

2022-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

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.

Interventions

DRUGGP681 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.

DRUGGP681 Simulant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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) .

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026