Influenza, HumanPhase 3NCT06573008
Study of GP681 Tablets Compared With Placebo in Patients With Influenza at High Risk of Influenza Complications
A Phase 3 study testing GP681 40mg and GP681 Simulant in people with Influenza, Human, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- GP681 40mg and GP681 Simulant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2024to 30 Dec 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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;
- Exclusion of participants who have received clinical research or screening within the past 30 days for any indication with a trial drug or device, or who have received clinical research for a monoclonal antibody drug for viral diseases within the past year;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The people's Hospital of Chizhou
Chizhou
Xuehong Jiang
About this study
Official title: 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
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
- Being tested
- GP681 40mg, GP681 Simulant
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP681 40mgDrug
2 x 20mg tablets taken orally
GP681 SimulantDrug
Placebo tablets matching GP681 40mg
| Study group | Role | What they receive |
|---|---|---|
| GP681 tablet 40mg | Experimental | Patients in the GP681 tablet 40mg group will receive a single oral dose of GP681 tablet 40mg. Receives: Drug: GP681 40mg |
| Placebo group | Placebo comparator | Patients in the Placebo group will receive a single oral dose of GP681 Simulant 40mg. Receives: Drug: GP681 Simulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to Day 15
Secondary outcomes (15)
Change From Baseline in Virus RNA (Q-PCR) at Each Time Point
Nasopharyngeal swabs were obtained for viral quantitation.
Measured: Day 2, Day3, Day5, Day7
Percentage of Participants With Positive Influenza Virus RNA by Q-PCR at Each Time Point
The percentage of patients positive for virus RNA by RT-PCR.
Measured: Day 2, Day3, Day5, Day7
Area Under the Concentration (AUC) of virus RNA by Q-PCR and AUC of virus titer
AUC of the viral load by RT-PCR and AUC of viral titer measured from baseline to Day 7
Measured: Up to Day 7
Change in the total score of 7 influenza symptoms
The composite symptom score is the total score of the 7 influenza symptoms(Sum of symptom scores) as assessed by the participant, and ranges from 0 to 21.
Measured: Up to Day15
Time to Cessation of Viral Shedding Determined by Virus Titer
Defined as the time between the initiation of the study treatment and first time when the virus titer was below the limit of detection.
Measured: up to Day7
Time to alleviation of each influenza symptom.
Defined as the time from the start of the study treatment to the start of the time when the individual symptom was assessed by the participant as have alleviated (scoring 0 or 1 point), maintained, or improved , for at duration of at least 21.5 hours.
Measured: Up to Day15
Time to Alleviation of the Three Respiratory Symptoms in Participants
Defined as the time from the start of study treatment to the time when all 3 respiratory symptoms (cough, sore throat, and nasal congestion) were alleviated, maintained, or improved, as defined below, for a duration of at least 21.5 hours.
Measured: Up to Day15
Time to Alleviation of the Four Systemic Symptoms in Participants
Defined as the time between the initiation of study treatment to the time when all 4 systemic symptoms (headache, feverishness or chills, muscle or joint pain, and fatigue) were alleviated, maintained, or improved, for a duration of at least 21.5 hours.
Measured: Up to Day15
Percentage of Participants Reporting Normal Temperature at Each Time Point
Defined as the percentage of patients whose axillary temperature dropped to less than 37.3ºC after the initiation of study treatment
Measured: 12h, 24h,48h,72h,96h,120h,144h,168h
Time to Resolution of Fever
Defined as the time between the initiation of the study treatment and the resolution of fever. The resolution of fever was defined as the time when the participant's self-measured axillary temperature became less than 37.3ºC and was maintained at less than 37.3ºC for a duration of at least 21.5 hours.
Measured: Up to Day15
Incidence of influenza-related complications
Defined as the percentage of subjects in the analysis population who experience each influenza-related complication (hospitalization, death, sinusitis, bronchitis, otitis media, and pneumonia) as an adverse event after the initiation of the study treatment.
Measured: Up to Day15
Proportion of patients and frequency in combination use of acetaminophen.
The proportion of patients who use acetaminophen in the duration of the study
Measured: Up to Day15
The percentage of participants who received systemic antibiotics.
The proportion of patients receiving systemic antibiotic therapy after treatment initiation.
Measured: Up to Day15
The percentage of participants with secondary influenza infections after enrollment
Defined as the percentage of subjects who develop secondary influenza infections after treatment initiation in the study population as an adverse event after the initiation of the study treatment
Measured: Up to Day15
Time to Return to Preinfluenza Health Status
Defined as the participant's pre-influenza daily activity score from the start of treatment until the participant's recovery to influenza. Subjects whose baseline self-reported daily activity score was higher than or equal to the pre-influenza score were excluded from the analysis.
Measured: Up to Day15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start11 Nov 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573008
- Sponsor's protocol ID
- GP681-202402
- Status last verified
- Dec 2024
- First submitted
- 18 Aug 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06573008
- Acronym / sponsor ID
- GP681-202402
- Conditions
- Influenza, Human
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GP681 tablet 40mg | Experimental | Drug: GP681 40mgPatients in the GP681 tablet 40mg group will receive a single oral dose of GP681 tablet 40mg. |
| Placebo group | Placebo comparator | Drug: GP681 SimulantPatients in the Placebo group will receive a single oral dose of GP681 Simulant 40mg. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (25 listed)
- 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:
- 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:
- 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:
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GP681 40mg2 x 20mg tablets taken orally | Drug | GP681 tablet 40mg |
| GP681 SimulantPlacebo tablets matching GP681 40mg | Drug | Placebo group |
Primary outcome
Time to alleviation of influenza symptoms
Time frame: up to Day 15
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).
15 secondary outcomes
Change From Baseline in Virus RNA (Q-PCR) at Each Time Point
Time frame: Day 2, Day3, Day5, Day7
Percentage of Participants With Positive Influenza Virus RNA by Q-PCR at Each Time Point
Time frame: Day 2, Day3, Day5, Day7
Area Under the Concentration (AUC) of virus RNA by Q-PCR and AUC of virus titer
Time frame: Up to Day 7
Change in the total score of 7 influenza symptoms
Time frame: Up to Day15
Time to Cessation of Viral Shedding Determined by Virus Titer
Time frame: up to Day7
Time to alleviation of each influenza symptom.
Time frame: Up to Day15
Time to Alleviation of the Three Respiratory Symptoms in Participants
Time frame: Up to Day15
Time to Alleviation of the Four Systemic Symptoms in Participants
Time frame: Up to Day15
Percentage of Participants Reporting Normal Temperature at Each Time Point
Time frame: 12h, 24h,48h,72h,96h,120h,144h,168h
Time to Resolution of Fever
Time frame: Up to Day15
Incidence of influenza-related complications
Time frame: Up to Day15
Proportion of patients and frequency in combination use of acetaminophen.
Time frame: Up to Day15
The percentage of participants who received systemic antibiotics.
Time frame: Up to Day15
The percentage of participants with secondary influenza infections after enrollment
Time frame: Up to Day15
Time to Return to Preinfluenza Health Status
Time frame: Up to Day15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GP681 40mg and GP681 Simulant in people with Influenza, Human, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siyuan Xi (84206250, ZRYHYYGCPEC@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to alleviation of influenza symptoms (time frame: up to Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.