Respiratory Syncytial Virus Infection
Conditions
Brief summary
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).
Interventions
DRUGSIM0916
Dose: 20 mg/kg TID
DRUGSIM0916 Placebo
Dose: 20 mg/kg TID
Sponsors
Simcere Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
1 Months to 36 Months
Healthy volunteers
No
Inclusion criteria
1. Infants and young children aged ≥ 1 month and ≤ 36 months, regardless of gender; 2. Weight ≥ 2.5 kg and ≤ 20 kg; 3. Positive RSV antigen or nucleic acid test 4. Duration of illness due to RSV infection ≤ 96 hours; 5. Presence of tachypnea and wheezing; 6. Wang Bronchiolitis Score≥ 5; 7. For subjects aged \< 12 months, head circumference should be within the normal range corresponding to their age and gender.
Exclusion criteria
1. Subjects who have received protocol-specified prohibited medications: 2. Subjects with severe intrapulmonary complications or extrapulmonary complications; 3. Subjects requiring vasopressors or inotropic agents; 4. Subjects with known concurrent SARS-CoV-2 infection, influenza virus infection, Mycoplasma infection, or suspected concurrent bacterial or other pathogen infections; 5. Subjects with a known history of hypercapnia; 6. Subjects with chronic or persistent feeding difficulties; 7. Subjects with gastrointestinal diseases that the investigator believes may significantly affect the absorption of the study drug; 8. Subjects with congenital metabolic abnormalities; 9. Subjects with bronchopulmonary dysplasia requiring assisted ventilation or clinically significant congenital respiratory tract abnormalities; 10. Subjects with congenital heart disease (CHD) that the investigator assesses may affect efficacy evaluation; 11. Subjects with clinical evidence of hepatic decompensation; or abnormal liver function tests; 12. Subjects with renal failure, including renal abnormalities potentially related to renal insufficiency or abnormal renal function tests; 13. Subjects with a known history of HIV positivity, or suspected to be HIV positive by the investigator; 14. Subjects with known or suspected primary immunodeficiency diseases or transplant recipients; 15. Subjects with a history of epilepsy or febrile convulsions; 16. Subjects with a personal or family history of severe allergies or allergies; 17. Subjects with active or uncontrolled respiratory, cardiac, hepatic, central nervous system, or renal diseases, or other medical conditions deemed unsuitable for enrollment by the investigator; 18. Subjects who participated in other drug or medical device clinical trials and received investigational products or devices; 19. Subjects deemed unsuitable for participation in this study by the investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The earliest time from the first dose to the sustained resolution of 6 RSV infection-related clinical signs and symptoms | Day 26 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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. | Day 26 |
| Change in Wang Bronchiolitis Score from baseline on Days 2-6 and Day 14 after the first dose | Day 26 |
| Time from the first dose to disease recovery: the earliest time when Wang Bronchiolitis Score ≤ 1 | 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 | Day 26 |
| Earliest time from the first dose to the sustained resolution of individual RSV infection-related clinical signs and symptoms | Day 26 |
| Proportion of subjects with resolution of individual RSV infection-related clinical signs and symptoms | 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; | 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 | 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 | Day 26 |
| Number and duration of admissions to the Intensive Care Unit (ICU) due to RSV infection-related diseases; | Day 26 |
| Number of times of non-invasive positive pressure ventilation or mechanical ventilation received due to RSV infection-related diseases | Day 26 |
Countries
China
Contacts
CONTACTzhibiao song
PRINCIPAL_INVESTIGATORhanmin liu
West China Second University Hospital
PRINCIPAL_INVESTIGATORlanjuan Li
Shulan (Hangzhou) Hospital
Outcome results
None listed