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.
Male or female patients aged ≥12 years at the time of signing the informed consent form.
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;
Time of the first increase in body temperature (axillary temperature ≥37.3℃)
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;
Parallel
GP681 40mg
Drug2 x 20mg tablets taken orally
GP681 Simulant
DrugPlacebo tablets matching GP681 40mg
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).
Change From Baseline in Virus RNA (Q-PCR) at Each Time Point
Nasopharyngeal swabs were obtained for viral quantitation.
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.
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
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.
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