Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GP681 tablet 40mg | Experimental | Patients in the GP681 tablet 40mg group will receive a single oral dose of GP681 tablet 40mg. |
|
| Placebo group | Placebo Comparator | Patients in the Placebo group will receive a single oral dose of GP681 Simulant 40mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GP681 40mg | Drug | 2 x 20mg tablets taken orally |
| |
| GP681 Simulant |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Virus RNA (Q-PCR) at Each Time Point | Nasopharyngeal swabs were obtained for viral quantitation. | Day 2, Day3, Day5, Day7 |
| Percentage of Participants With Positive Influenza Virus RNA by Q-PCR at Each Time Point |
Not provided
Inclusion Criteria:
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;
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:
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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siyuan Xi | Contact | 84206250 | ZRYHYYGCPEC@126.com | |
| Bin Cao, phd | Contact | 13911318339 | caobin_ben@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The people's Hospital of Chizhou | Recruiting | Chizhou | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Placebo tablets matching GP681 40mg |
|
The percentage of patients positive for virus RNA by RT-PCR.
| 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 | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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 | Up to Day15 |
| The percentage of participants who received systemic antibiotics. | The proportion of patients receiving systemic antibiotic therapy after treatment initiation. | 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 | 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. | Up to Day15 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |