To evaluate the efficacy and safety of interferon α1b (GB05) in the treatment of children under 2 years of age with respiratory syncytial virus infection.
The study has been divided into two parts, 60 subjects will be randomly assigned to the 4μg/kg dose group or 6μg/kg dose group or the blank control group, to receive nebulized GB05 therapy, twice daily for no more than 7 days. After comprehensive evaluation of effectiveness and safety, and confirmation of the optimal dose, the sample size will be re-calculated to enter the second part of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
322
Participants will receive Human interferon α1b Inhalation Solution
Participants will receive Inhalation Solution Placebo
Children's Hospital, Capital Institute of Pediatrics
Beijing, Beijing Municipality, China
RECRUITINGWang bronchiolitis score chanced by percentage from baseline
The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of \< 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of ≥9 indicates that the patient is severe.
Time frame: day 5
Wang bronchiolitis score chanced by percentage from baseline
The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of \< 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of ≥9 indicates that the patient is severe.
Time frame: day 1 to day of last administration (except day 5)
Wang bronchiolitis score of 0 in proportion
The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of \< 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of ≥9 indicates that the patient is severe.
Time frame: day 5
Wang bronchiolitis score total score < 5 points
The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of \< 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of ≥9 indicates that the patient is severe.
Time frame: day 5
Wang bronchiolitis score, the first time the total score reaches < 5 points
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of \< 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of ≥9 indicates that the patient is severe.
Time frame: day 5
RSV viral load
qPCR test
Time frame: From predose to 120 hours postdose