This randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of Onradivir Tablets in participants aged 12 to 17 years with influenza A virus infection. The trial plans to enroll approximately 150 adolescent participants (12-17 years) with uncomplicated influenza A, confirmed by rapid antigen/nucleic acid testing and within 48 hours of symptom onset. Eligible participants who meet the inclusion criteria and do not meet any exclusion criteria will be randomized in a 2:1 ratio to receive either Onradivir Tablets or placebo once daily for 5 consecutive days. The study consists of a screening period, a treatment period, and a safety follow-up period. Each participant will be followed up until Day 14 after the first dose. Nasopharyngeal swabs will be collected at screening, Day 2, Day 4, Day 5, and Day 10 for virological testing, including: Viral load measurement by reverse transcription quantitative polymerase chain reaction (RT-qPCR) Viral titer determination by culture assay (50% tissue culture infectious dose, TCID₅₀) Throughout the treatment and safety follow-up periods, participants will record body temperature, influenza symptom scores, and daily activity scores using a diary card. Clinical laboratory tests will be performed at screening, Day 5, and Day 15. Physical examinations and vital signs measurements will be conducted at each follow-up visit. Adverse events and concomitant medications will be documented throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
A placebo that resembles Onradivir tablet in appearance, weight, and odor. The external packaging of Onradivir tablet and the placebo is identical. Take placebo once daily, 3 tablets per dose, for a total of 5 days (5 doses).
Take Onradivir Tablets once daily, 600 mg (3 tablets) per dose, for a total of 5 days (5 doses).
Time to alleviation of influenza symptoms
Time frame: Up to Day 15
Time to fever resolution
axillary temperature ≤37.2°C
Time frame: Up to Day 15
Change from baseline in influenza A viral quantification
Change from baseline in influenza A viral quantification (viral titer and viral RNA load)
Time frame: Up to Day 15
Duration of detectable viral titer and viral RNA load
Time frame: Up to Day 15
Proportion of participants with positive viral titer and viral load
Time frame: Up to Day 15
Area under the curve of viral quantification versus time
Area under the curve (AUC) of viral quantification (viral titer and viral RNA load) versus time
Time frame: Up to Day 15
Incidence of influenza-related complications
Incidence of influenza-related complications (hospitalization, death, sinusitis, bronchitis, otitis media, pneumonia, myocarditis, pericarditis, neurological complications, musculoskeletal complications, etc.)
Time frame: Up to Day 15
Proportion of participants with symptom resolution
Time frame: Up to Day 15
Time to resolution of systemic symptoms
Time to resolution of systemic symptoms (headache, fever or chills, muscle or joint pain, fatigue)
Time frame: Up to Day 15
Time to resolution of respiratory symptoms
Time to resolution of respiratory symptoms (cough, sore throat, nasal congestion)
Time frame: Up to Day 15
Time to resolution of individual symptoms
Time frame: Up to Day 15
Proportion of participants with fever resolution
Time frame: Up to Day 15
Proportion and frequency of participants using symptomatic treatment medications
Time frame: Up to Day 15
Time to return to normal daily activities
Time frame: Up to Day 15
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