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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIM0916 | Experimental |
| |
| SIM0916 Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIM0916 | Drug | Dose: 20 mg/kg TID |
| |
| SIM0916 Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The 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. | Day 26 |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in viral load from baseline on Days 2-6 and Day 14 after the first dose | Day 26 | |
| Proportion of subjects with viral load below the Lower Limit of Quantitation (LLOQ) on Days 2-6 and Day 14 after the first dose | Day 26 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhibiao song | Contact | 86-13641133681 | songzhibiao@simcere.com |
| Name | Affiliation | Role |
|---|---|---|
| hanmin liu | West China Second University Hospital | Principal Investigator |
| lanjuan Li | Shulan (Hangzhou) Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital Of Xiamen University | Recruiting | Xiamen | Fujian | China |
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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Parallel Assignment
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| Drug |
Dose: 20 mg/kg TID |
|
| 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 |
| Area under the viral load-time curve from baseline to Days 2-6 and Day 14 after the first dose | Day 26 |
| Hunan Children's Hospital | Recruiting | Changsha | Hunan | China |
|
| West China Second University Hospital Sichuan University | Not yet recruiting | Chengdu | Sichuan | China |
|
| Shulan(hangzhou)Hospital | Not yet recruiting | Hangzhou | Zhejiang | China |
|
| D014777 | Virus Diseases |
| D007239 | Infections |