This study will evaluate the efficacy, safety, and population pharmacokinetics of a single, oral dose of GP681 compared with placebo in patients aged 12 to 65 years with acute uncomplicated influenza virus infection
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
591
2X20mg tablets taken orally
Placebo tablets matching GP681 40mg
The First People's Hospital of Wenling
Wenling, Zhejiang, China
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) for at least 21.5 hours.
Time frame: Up to Day 15
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.
Time frame: Up to Day7
Percentage of Participants With Positive Influenza Virus RNA by RT-PCR at Each Time Point
The percentage of patients positive for virus RNA by RT-PCR.
Time frame: Days 2, 3, 5,7
Percentage of Participants With Positive Influenza Virus Titer at Each Time Point
Virus titer was quantified from nasopharyngeal swabs by tissue culture methods.
Time frame: Days 2, 3, 5,7
Area Under the Concentration (AUC) of virus RNA by RT-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
Time frame: Up to Day 7
Change From Baseline in Virus RNA (RT-PCR) at Each Time Point
Nasopharyngeal swabs were obtained for viral quantitation.
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Time frame: Days 2, 3, 5,7
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.
Time frame: Up to Day15
Time to alleviation of each influenza symptom
Defined as the time from the start of treatment to the start of the time period when the individual symptom was assessed by the participant as 0 (None) or 1 (Mild) for a duration of at least 21.5 hours.
Time frame: Up to Day15
Time to Alleviation of the Four Systemic Symptoms in Participants
Defined as the time between the initiation of the study treatment to the time when all 4 systemic symptoms (headache, fever or chills, muscle or joint pain, and fatigue) were assessed by the participant as 0 (None) or 1 (Mild) for a duration of at least 21.5 hours.
Time frame: 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 assessed by the participant as absent (0) or mild (1) for at least 21.5 hours
Time frame: 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 37.3 degree Celsius \[ºC\] after the initiation of study treatment
Time frame: 12, 24, 48, 72, 96,120, 144 and168 hours after the initial dose of study treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Day15
Time to Return to Normal Activities of Daily Life
Defined as the time between the initiation of the study treatment and the return to normal activities of daily life. The return to normal activities of daily life is defined as the time when the subject assesses his/her activities as 10. Subjects with a baseline self-rated daily activity score of 10 are not included in this analysis.
Time frame: Up to Day15
Change from baseline in health-related quality of life according to EuroQol 5 dimensions 5 (EQ-5D-5L) questionnaire
The EQ-5D-5L is a self-reported health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Time frame: Up to Day15