NCT07402512尚未招募3 期
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
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 498
- 试验地点
- 2
- 主要终点
- The earliest time from the first dose to the sustained resolution of 6 RSV infection-related clinical signs and symptoms
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Subjects who have received protocol-specified prohibited medications:
- •Subjects with severe intrapulmonary complications or extrapulmonary complications;
- •Subjects requiring vasopressors or inotropic agents;
- •Subjects with known concurrent SARS-CoV-2 infection, influenza virus infection, Mycoplasma infection, or suspected concurrent bacterial or other pathogen infections;
- •Subjects with a known history of hypercapnia;
- •Subjects with chronic or persistent feeding difficulties;
- •Subjects with gastrointestinal diseases that the investigator believes may significantly affect the absorption of the study drug;
- •Subjects with congenital metabolic abnormalities;
- •Subjects with bronchopulmonary dysplasia requiring assisted ventilation or clinically significant congenital respiratory tract abnormalities;
- •Subjects with congenital heart disease (CHD) that the investigator assesses may affect efficacy evaluation;
- •Subjects with clinical evidence of hepatic decompensation; or abnormal liver function tests;
- •Subjects with renal failure, including renal abnormalities potentially related to renal insufficiency or abnormal renal function tests;
- •Subjects with a known history of HIV positivity, or suspected to be HIV positive by the investigator;
- •Subjects with known or suspected primary immunodeficiency diseases or transplant recipients;
- •Subjects with a history of epilepsy or febrile convulsions;
- •Subjects with a personal or family history of severe allergies or allergies;
- •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;
- •Subjects who participated in other drug or medical device clinical trials and received investigational products or devices;
- •Subjects deemed unsuitable for participation in this study by the investigator for any other reason.
研究组 & 干预措施
SIM0916
Experimental
干预措施: SIM0916 (Drug)
SIM0916 Placebo
Placebo Comparator
干预措施: SIM0916 Placebo (Drug)
结局指标
主要结局
The earliest time from the first dose to the sustained resolution of 6 RSV infection-related clinical signs and symptoms
时间窗: 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.
次要结局
- 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)
研究者
研究点 (2)
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