Study of GP681 Tablets Compared With Placebo in Patients With Influenza at High Risk of Influenza Complications

NCT06573008 | Recruiting Phase 3

• 1 other identifier: GP681-202402
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza, Human

Outcome Measures

Primary Outcomes (1)

• Time to alleviation of influenza symptoms

  Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe 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), maintained, or improved, as defined below, for at duration of at least 21.5 hours. Preexisting symptoms (cough, fatigue, or muscle/joint pain that existed prior to influenza) that were worse at baseline must have improved at least 1 point from baseline Preexisting symptoms not worse at baseline must have maintained baseline severity New symptoms must have alleviated, defined as a symptom score of none (0) or mild (1).

  up to Day 15

Secondary Outcomes (15)

• Change From Baseline in Virus RNA (Q-PCR) at Each Time Point

  Day 2, Day3, Day5, Day7

• Percentage of Participants With Positive Influenza Virus RNA by Q-PCR at Each Time Point

  Day 2, Day3, Day5, Day7

• Area Under the Concentration (AUC) of virus RNA by Q-PCR and AUC of virus titer

  Up to Day 7

• Change in the total score of 7 influenza symptoms

  Up to Day15

• Time to Cessation of Viral Shedding Determined by Virus Titer

  up to Day7

Study Arms (2)

GP681 tablet 40mg

EXPERIMENTAL

Patients in the GP681 tablet 40mg group will receive a single oral dose of GP681 tablet 40mg.

Drug: GP681 40mg

Placebo group

PLACEBO COMPARATOR

Patients in the Placebo group will receive a single oral dose of GP681 Simulant 40mg.

Drug: GP681 Simulant

Interventions

GP681 40mg DRUG

2 x 20mg tablets taken orally

GP681 tablet 40mg

GP681 Simulant DRUG

Placebo tablets matching GP681 40mg

Placebo group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• History of allergic reactions attributed to GP681,Acetaminophen, bromohexine hydrochloride or any of the ingredients of its formulation.
• Known history of dysphagia or any gastrointestinal disease that affects drug absorption (including but not limited to chronic diarrhea, inflammatory bowel disease, tuberculosis of the intestines, gastrinoma, short bowel syndrome, postoperative gastrectomy, etc.);
• Screening patients who, in the opinion of the investigator, require hospitalization due to severe influenza virus infection;.
• Screening patients who, at the time of screening, are clinically diagnosed with bacterial or other viral infections requiring systemic antibacterial or antiviral treatment;
• Cancer patients who are currently receiving or have received chemotherapy or radiation therapy within the past year (excluding non-melanoma skin cancer and thyroid cancer)
• Known HIV-infected patients;
• Organ or bone marrow transplant recipients;
• Patients who are currently receiving \>20mg/d of prednisone or equivalent chronic systemic corticosteroid therapy;
• Patients who have used anti-influenza virus drugs (including neuraminidase inhibitors, hemagglutinin inhibitors, and M2 ion channel blockers, such as oseltamivir, zanamivir, palivizumab, favipiravir, abidol, marabolexavir, amantadine or rimantadine or other anti-influenza virus drugs approved by NMPA) within the past 2 weeks or who have received influenza vaccination within the past 6 months;
• Known to have had a previous history of severe liver function impairment such as cirrhosis with ascites, hepatic encephalopathy, or a history of upper gastrointestinal bleeding;
• Estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula \<30mL/min/1.73m2 at the time of screening;
• Individuals with a history of alcohol abuse or substance abuse (more than 14 units of alcohol per week, 1 unit of alcohol = 360 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine with an alcohol content of 12%);
• Adult reproductive-age females who are pregnant or breastfeeding or who have a positive pregnancy test. Women who are infertile (i.e., women who have had a hysterectomy, bilateral oophorectomy, or tubal ligation for medical reasons or who are postmenopausal - defined as age \> 50 years and menopause has occurred for at least 2 years) do not need a pregnancy test;
• Patients who, in the opinion of the Investigator, may not be qualified or suitable for the study.

Sponsors & Collaborators

• Jiangxi Qingfeng Pharmaceutical Co. Ltd.: lead

Study Sites (1)

The people's Hospital of Chizhou

Chizhou, China

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Central Study Contacts

Siyuan Xi

CONTACT

84206250; ZRYHYYGCPEC@126.com

Bin Cao, phd

CONTACT

13911318339; caobin_ben@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 27, 2024
• Study Start: November 11, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)