This is a randomized, double-blind, placebo-controlled, parallel-group trial conducted in infants and young children aged 1 to 36 months with RSV infection. A total of 498 subjects are expected to be enrolled and randomly assigned to the investigational product group or the placebo group in a 2:1 ratio; Administration will be based on the subject's weight, with a dose of 20 mg/kg three times daily for 5 consecutive days (15 doses).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
498
Dose: 20 mg/kg TID
Dose: 20 mg/kg TID
The First Affiliated Hospital Of Xiamen University
Xiamen, Fujian, China
RECRUITINGHunan Children's Hospital
Changsha, Hunan, China
RECRUITINGWest China Second University Hospital Sichuan University
Chengdu, Sichuan, China
NOT_YET_RECRUITINGShulan(hangzhou)Hospital
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGThe earliest time from the first dose to the sustained resolution of 6 RSV infection-related clinical signs and symptoms
The earliest time from the first dose to the sustained resolution of 6 RSV infection-related clinical signs and symptoms. Resolution of 6 RSV infection-related clinical signs and symptoms is defined as a score of 0 for all of 6 RSV infection-related clinical signs.
Time frame: Day 26
The earliest time from the first dose to the sustained relief/resolution of wheezing.Relief/resolution of wheezing is defined as a wheezing score ≤ 1.
Time frame: Day 26
Change in Wang Bronchiolitis Score from baseline on Days 2-6 and Day 14 after the first dose
Time frame: Day 26
Time from the first dose to disease recovery: the earliest time when Wang Bronchiolitis Score ≤ 1
Time frame: Day 26
Proportion of subjects achieving RSV disease recovery (Wang Bronchiolitis Score ≤ 1 at daily assessment) on each day from Day 2 to Day 6 and on Day 14 after the first dose
Time frame: Day 26
Earliest time from the first dose to the sustained resolution of individual RSV infection-related clinical signs and symptoms
Time frame: Day 26
Proportion of subjects with resolution of individual RSV infection-related clinical signs and symptoms
Time frame: Day 26
Proportion of subjects with wheezing score ≤ 1 at daily assessment on each day from Day 2 to Day 6 and on Day 14 after the first dose;
Time frame: Day 26
Time from the first dose to the sustained relief/resolution of cough. Relief/resolution of cough is defined as a cough score ≤ 1
Time frame: Day 26
Proportion of subjects with cough score ≤ 1 at daily assessment on each day from Day 2 to Day 6 and on Day 14 after the first dose
Time frame: Day 26
Number and duration of admissions to the Intensive Care Unit (ICU) due to RSV infection-related diseases;
Time frame: Day 26
Number of times of non-invasive positive pressure ventilation or mechanical ventilation received due to RSV infection-related diseases
Time frame: Day 26
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