Actively Recruiting
A Multi-center, Randomized, Double-blind, Placebo-controlled Study of GP681 Tablets Compared With Placebo in Patients With Influenza at High Risk of Influenza Complications
Led by Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Updated on 2024-12-04
328
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and how the body processes a single oral dose of GP681 compared to a placebo in people aged 12 and older who have influenza and are at high risk for complications. This Phase III clinical trial aims to better understand the impact of GP681 on influenza symptoms and viral activity in this vulnerable population. Participants will be randomly assigned to receive either a 40mg oral dose of GP681 tablets or a matching placebo tablet. This is a double-blind, placebo-controlled study, meaning neither the participants nor the researchers know who receives the actual drug or placebo. The study will measure outcomes such as the time it takes for influenza symptoms to improve and changes in viral RNA levels over a 15-day period. During the study, participants will be monitored closely with symptom evaluations, virus testing at multiple time points, and assessments of fever resolution and influenza-related complications. They will keep health diaries and attend study visits for up to 15 days to track their recovery and any side effects. Safety and efficacy data will be collected throughout this period to assess the impact of GP681 compared with placebo.
CONDITIONS
Brief Title
Study of GP681 Tablets Compared With Placebo in Patients With Influenza at High Risk of Influenza Complications
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 12 years or older at the time of consent
- Confirmed influenza diagnosis by positive rapid antigen or molecular test
- Fever (axillary temperature ≥37.3°C) and at least one moderate or greater systemic symptom (headache, fever/chills, muscle/joint aches, fatigue) and one respiratory symptom (cough, sore throat, nasal congestion)
- Symptom onset within 48 hours before randomization
- At least one high-risk condition for influenza complications, including asthma, chronic lung disease, diabetes, immune impairment, neurological disorders, heart disease (excluding isolated hypertension), age ≥65 years, blood or metabolic diseases, liver or kidney disease, obesity (BMI ≥30), or recent postpartum women not breastfeeding
- Agreement to use effective contraception for one month after drug withdrawal if of childbearing potential
- Willingness and ability to provide informed consent and comply with study procedures including health diary recording
You will not qualify if you...
- History of allergic reactions to GP681, acetaminophen, bromohexine hydrochloride, or formulation ingredients
- Known swallowing difficulties or gastrointestinal diseases affecting drug absorption
- Need for hospitalization due to severe influenza infection
- Current bacterial or other viral infections requiring systemic antibiotic or antiviral treatment
- Recent chemotherapy or radiation therapy within the past year (excluding certain skin and thyroid cancers)
- Known HIV infection
- Organ or bone marrow transplant recipients
- Current systemic corticosteroid therapy exceeding 20mg prednisone daily or equivalent
- Recent use of anti-influenza drugs within two weeks or influenza vaccination within six months
- Participation in clinical trials involving investigational drugs or devices within the past 30 days or monoclonal antibody trials for viral diseases within one year
- Severe liver function impairment history
- Kidney function with eGFR <30 mL/min/1.73m2 at screening
- History of alcohol or substance abuse exceeding defined limits
- Pregnant or breastfeeding women or positive pregnancy test unless infertile or postmenopausal
- Any other condition judged by the investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 15 days
Participants receive a single oral dose of either GP681 40mg tablets or placebo.
Visits on Days 2, 3, 5, 7, and additional follow-up up to Day 15
Trial Site Locations
Total: 1 location
1
The people's Hospital of Chizhou
Chizhou, China
Actively Recruiting
Research Team
S
Siyuan Xi
B
Bin Cao, phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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