Actively Recruiting
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
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the efficacy, safety, and population pharmacokinetics of a single, oral dose of GP681 compared with placebo in patients aged 12 and older With Influenza at High Risk of Influenza Complications.
CONDITIONS
Official 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 signing the informed consent form
- Diagnosed with influenza confirmed by a positive rapid influenza antigen test or other rapid molecular method
- Fever of 37.3°C or higher at predose or more than 4 hours after taking antipyretics
- Presence of at least one moderate or greater severity systemic symptom (headache, fever/chills, muscle/joint aches, fatigue) and one respiratory symptom (cough, sore throat, nasal congestion)
- Onset of symptoms within 48 hours before random enrollment, defined as first fever or first new influenza-related symptom
- At least one high-risk factor for influenza complications such as asthma, chronic lung disease, endocrine disorders including diabetes, long-term care residence, immune system impairment, neurological disorders, heart disease (excluding isolated hypertension), age 65 or older, blood disorders, metabolic diseases, liver or kidney diseases, obesity (BMI ≥ 30), or female within 2 weeks postpartum and not breastfeeding
- Subjects of child-bearing potential agree to use effective contraception for 1 month after drug withdrawal
- Willing and able to provide informed consent and comply with study procedures including health diary records
You will not qualify if you...
- History of allergic reactions to GP681, acetaminophen, bromohexine hydrochloride, or any ingredients in the formulation
- Known swallowing difficulties or gastrointestinal diseases affecting drug absorption
- Patients requiring hospitalization for severe influenza infection
- Presence of bacterial or other viral infections requiring systemic antibacterial or antiviral treatment at screening
- Current or recent (within past year) chemotherapy or radiation therapy for cancer (except non-melanoma skin or thyroid cancer)
- Known HIV infection
- Organ or bone marrow transplant recipients
- Use of >20mg/day prednisone or equivalent chronic systemic corticosteroid therapy
- Use of anti-influenza drugs within past 2 weeks or influenza vaccination within past 6 months
- Participation in clinical research involving trial drugs or devices within past 30 days or monoclonal antibody research for viral diseases within past year
- History of severe liver impairment such as cirrhosis with complications
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m2 at screening
- History of alcohol or substance abuse exceeding defined limits
- Pregnant or breastfeeding females or positive pregnancy test; women who are infertile or postmenopausal do not require pregnancy test
- Investigator's judgment that the patient may not be suitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The people's Hospital of Chizhou
Chizhou, China
Actively Recruiting
Research Team
S
Siyuan Xi
CONTACT
B
Bin Cao, phd
CONTACT
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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