This study aims to evaluate the tolerability, safety, pharmacokinetic characteristics and efficacy of a single oral dose of GP681 powder for oral suspension in pediatric and adolescent patients with uncomplicated influenza. The study will also explore the optimal dose for a confirmatory clinical trial. Eligible patients who have been confirmed influenza virus infection and have experienced influenza symptoms within 48 hours prior to enrollment, will receive single dose of GP681 powder for oral suspension. The primary outcome measures included the observation of adverse events during the study, the pharmacokinetic parameters, as well as the efficacy endpoints including time to alleviation of influenza symptoms, viral clearance rate, changes in viral load, etc.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
0.5/1/2×20mg power for oral suspension taken orally
Ningbo Women and Children's hospital
Ningbo, Zhejiang, China
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Time frame: up to Day 15
Time to Alleviation of Symptoms (TTAS)
Defined as the time from the treatment start to meeting both the following criteria (a and b), with all criteria maintained for at least 21.5 hours: a. Time from treatment initiation to the normalization of body temperature (axillary temperature ≤37.4°C).
Time frame: up to Day 15
Viral clearance rate on Day 2 and Day 5 (if applicable)
Defined as the proportion of patients with viral titers below the quantifiable detection limit from the treatment start to Day 2 and Day 5 (if applicable)
Time frame: Days 2, 5
Proportion of patients with influenza viral RNA positivity (by Q-PCR) and measurable viral titers at each time point (Day 2 and Day 5, if applicable)
The percentage of patients positive for virus RNA by RT-PCR.Virus titer was quantified from nasopharyngeal swabs by tissue culture methods.
Time frame: Days 2, 5
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 5
Time frame: Up to Day 5
Change From Baseline in Virus RNA (RT-PCR) at Each Time Point
Nasopharyngeal swabs were obtained for viral quantitation.
Time frame: Days 2, 5
Time to Resolution of Fever
Defined as the time to a score of 0 (none) or 1 (mild) for individual symptoms from the 16 items on the CARIFS scale, sustained for at least 21.5 hours.
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.
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
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