Study of GP681 Tablets Compared With Placebo in Patients With Influenza at High Risk of Influenza Complications
NCT Number: NCT06573008
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Influenza, Human
Interventions: DRUG: GP681 40mg|DRUG: GP681 Simulant
Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 328
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2025-12-30

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.

Primary Outcome Measures: 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 Outcome Measures: 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, 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