A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Deurremidevir Hydrobromide for Oral Suspension in Infants and Young Children With Respiratory Syncytial Virus Infection
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).
• Infants and young children aged ≥ 1 month and ≤ 36 months, regardless of gender;
• Weight ≥ 2.5 kg and ≤ 20 kg;
• Positive RSV antigen or nucleic acid test
• Duration of illness due to RSV infection ≤ 96 hours;
• Presence of tachypnea and wheezing;
• Wang Bronchiolitis Score≥ 5;
• For subjects aged \< 12 months, head circumference should be within the normal range corresponding to their age and gender.