This study will evaluate the safety, efficacy and pharmacokinetics of Suraxavir Marboxil compared with oseltamivir in Pediatric Patients (2 to \<12 Years) with Uncomplicated Influenza.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
144
Suraxavir Marboxil will be administered as oral suspension: 40 mg (if weight ≥ 32 kg), or 20 mg (if weight \<32 kg).
Oseltamivir will be administered as oral granules: 30 mg (if weight ≤15 kg), 45 mg (if weight \> 15 kg to ≤ 23 kg), 60 mg (if weight \> 23 kg to ≤ 40 kg) or 75 mg (if weight \> 40 kg), twice daily (BID) for 5 days.
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 treatment initiation until meeting all criteria below for ≥21.5 consecutive hours: 1. Return to afebrile status (tympanic temperature ≤37.2°C); 2. Absence/Mild severity for all respiratory symptoms (cough, nasal congestion, rhinorrhea) on the Canadian Acute Respiratory Illness and Flu Scale (CARIFS); 3. "Yes" response to: "Has your child resumed normal daily activities as before illness?" in the Daily Activity Questionnaire.
Time frame: up to Day 15
Time to Viral Clearance
Time from treatment initiation until first undetectable viral titer (below the lower limit of quantification, LLOQ).
Time frame: up to Day 6
Viral Clearance Rate
Proportion of participants with viral titers below LLOQ at D2, D3 (if applicable), and D6 (if applicable).
Time frame: Days 2, 3,6
Proportion of patients with influenza viral RNA positivity (by Q-PCR) and measurable viral titers at each time point(D2, D3 if applicable, D6 if applicable).
The percentage of patients positive for virus RNA by Q-PCR. Virus titer was quantified from nasopharyngeal swabs by tissue culture methods.
Time frame: Days 2, 3,6
Area Under the Concentration (AUC) of virus RNA by Q-PCR and AUC of virus titer
AUC of the viral load by Q-PCR and AUC of viral titer measured from baseline to Day 6
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Time frame: Up to Day 6
Change From Baseline in Virus RNA (Q-PCR) at Each Time Point
Nasopharyngeal swabs were obtained for viral quantitation.
Time frame: Days 2, 3,6
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
Time to Resolution of Individual Symptoms
Time until absence/mild severity (CARIFS 16-item scale) for individual symptoms, sustained ≥21.5h.
Time frame: Up to Day15
Time to Resumption of Normal Daily Activities
Time until "Yes" response to the Daily Activity Questionnaire.
Time frame: Up to Day15
Incidence of Influenza-Related Complications
Including hospitalization, death, sinusitis, bronchitis, otitis media, and radiologically confirmed pneumonia.
Time frame: Up to Day15
Palatability Assessment of Suraxavir Marboxil using Visual Analog Scale (VAS)
Acceptability of taste assessed by 100-mm Visual Analog Scale (VAS) where 0 = "Very bad", 20 = "Bad", 50 = "Neutral", 80 = "Good", 100 = "Very good". Outcome reported as proportion of subjects with VAS score ≥50 (acceptable threshold) .
Time frame: Day1
Grittiness Assessment of Suraxavir Marboxil using Visual Analog Scale (VAS)
Perception of grittiness (grainy texture) assessed by 100-mm Visual Analog Scale (VAS) where 0 = "Severe grittiness", 20 = "Grittiness", 50 = "Slight grittiness", 80 = "No grittiness", 100 = "Smooth texture". Outcome reported as proportion of subjects with VAS score ≥50 (acceptable threshold) .
Time frame: Day1
Pharmacokinetic (PK) Endpoints
Plasma concentrations of Suraxavir Marboxil and its primary metabolite Suraxavir
Time frame: Up to Day6