A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study on the Safety and Efficacy of GP681 Tablets in Patients With Influenza at High Risk of Influenza Complications

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: t
View:

• Male or female patients aged ≥12 years at the time of signing the informed consent form.

• Patients with a diagnosis of influenza confirmed by all of the following:

⁃ Positive throat or nose swab by rapid influenza antigen test (RAT) (where rapid influenza virus nucleic acid test or other rapid molecular diagnostic methods are also acceptable);

∙ Fever (axillary temperature ≥37.3℃) in the predose examinations or \> 4 hours after dosing of antipyretics if they were taken;

• At least one of the following systemic symptoms and respiratory symptoms respectively associated with influenza are present with a severity of moderate or greater:

• Systemic symptoms: headache, fever or chills, muscle or joint aches, fatigue; Respiratory system symptoms: cough, sore throat, nasal congestion.

• The time interval between the onset of symptoms and random enrollment is 48 hours or less. The onset of symptoms is defined as either:

‣ Time of the first increase in body temperature (axillary temperature ≥37.3℃)

⁃ Time when the patient experiences at least 1 new general or respiratory symptom related to influenza

• Referring to the standards of the Centers for Disease Control and Prevention (CDC) in the United States and the definition of high-risk populations for influenza complications in the Expert Consensus on Diagnosis and Treatment of Influenza in Adults in the Emergency Department (2022 Edition), that is, if at least one of the following criteria is met, the patient will be considered at high risk of influenza complications:

‣ Asthma or chronic lung diseases \[such as chronic obstructive pulmonary disease (COPD), cystic fibrosis, chronic bronchitis, bronchiectasis, emphysema, chronic interstitial pneumonia, etc.\];

⁃ Endocrine disorders (including diabetes);

⁃ Residents of long-term care institutions (such as nursing homes);

⁃ Immune system impairment (including patients receiving chronic systemic corticosteroid treatment of ≤20mg/d prednisone or an equivalent dose);

⁃ Neurological and neurodevelopmental disorders (including brain, spinal cord, peripheral nerve and muscle diseases, such as cerebral palsy, epilepsy (episodic disorders), stroke, muscular dystrophy or spinal cord injury);

⁃ Heart diseases (such as congenital heart disease, congestive heart failure, or coronary artery disease), but not including hypertension without any other cardiac-related symptoms;

⁃ Patients aged ≥65 years;

⁃ Blood system diseases (such as sickle cell disease);

⁃ Metabolic system diseases (such as hereditary metabolic diseases and mitochondrial diseases);

‣ Liver diseases (such as chronic hepatitis B, chronic hepatitis C, non-alcoholic steatohepatitis);

‣ Kidney diseases (estimated glomerular filtration rate eGFR ≥ 30 mL/min/1.73m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula);

‣ Obese patients (BMI ≥ 30 kg/m2);

‣ Female patients within 2 weeks postpartum and not breastfeeding.

• Subjects of child-bearing potential who agree to use a highly effective method of contraception for 1 month after drug withdrawal.

• Subjects and/or their guardian who are willing to provide written informed consent and consent to participate in the study, able to understand the study and comply with all study procedures, including patient health diary records.

Locations
Other Locations
China
The people's Hospital of Chizhou
RECRUITING
Chizhou
Contact Information
Primary
Siyuan Xi
ZRYHYYGCPEC@126.com
84206250
Backup
Bin Cao, phd
caobin_ben@163.com
13911318339
Time Frame
Start Date: 2024-11-11
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 328
Treatments
Experimental: GP681 tablet 40mg
Patients in the GP681 tablet 40mg group will receive a single oral dose of GP681 tablet 40mg.
Placebo_comparator: Placebo group
Patients in the Placebo group will receive a single oral dose of GP681 Simulant 40mg.
Related Therapeutic Areas
Sponsors
Leads: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

This content was sourced from clinicaltrials.gov

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