NCT04622332已完成1 期
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 9
- 主要终点
- Number of Patients With Any TEAEs During the Treatment Period Baseline to Day 14
研究概览
简要总结
Primary Objective:
• To evaluate overall safety and tolerability of SIR1-365 in patients with severe COVID-19
Secondary Objectives:
- To assess the clinical efficacy of SIR1-365 in patients with severe COVID-19
- To assess the effects of SIR1-365 on multiple inflammatory biomarker levels including C-reactive protein (CRP), ferritin, lymphocyte and neutrophil counts, cytokines, and chemokines
- To assess the effects of SIR1-365 on biomarkers indicative of target engagement in patients with severe COVID-19
- To assess the effects of SIR1-365 on biomarkers indicative of kidney injury in patients with severe COVID-19
- To assess the effects of SIR1-365 on biomarkers indicative of cardiovascular endothelial cell damage in patients with severe COVID-19
- To characterize plasma pharmacokinetics (PK) of SIR1-365 in patients with severe COVID-19
详细描述
Study duration per participant is approximately 28 days including a 14-day treatment period
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)
盲法说明
Blinded
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patient with clinical diagnosis of SARS-CoV-2 virus infection per World Health Organization criteria including positive nucleic acid test of any specimen (e.g., respiratory, blood, or other bodily fluid) within 2 weeks prior to screening.
- •Symptoms suggestive of severe systemic illness with COVID-19, which could include any of the following symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath at rest, or respiratory distress.
- •Clinical signs indicative of severe systemic illness with COVID-19, which could include any of the following clinical signs: respiratory rate ≥ 30 per minutes, heart rate ≥ 125 per minute, SpO2 ≤ 93% on room air, or PaO2/FiO2 ratio < 300 mmHg.
- •Men or women ≥18 but ≤80 years of age at the time of signing the informed consent.
- •Patient is able to understand the purpose and risks of the study and provide signed and dated informed consent or have a legal representative provide consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).
排除标准
- •Patient requires endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO), or clinical diagnosis of respiratory failure.
- •Patient with shock defined by systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg or requiring vasopressor.
- •Patient with multi-organ dysfunction or failure defined by an increase in the Sequential Organ Failure Assessment score of 2 points or more.
- •Patient is unlikely to survive beyond 2 days at the discretion of Investigator.
- •Patient has used chronic systemic corticosteroids within 2 weeks prior to screening.
- •Patient with positive results for human immunodeficiency virus (HIV) or hepatitis B or C test.
- •Patient has known active tuberculosis (TB), history of uncontrolled TB, suspected or known systemic bacterial or fungal infections within 4 weeks prior to screening.
- •Patient has any other condition, which makes the patient unsuitable for study participation
研究组 & 干预措施
SIR1-365
Experimental
SIR1-365 dose 1 daily for 14 days
干预措施: SIR1-365 (Drug)
Matching placebo
Placebo Comparator
Matching placebo dose 1 daily for 14 days
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Number of Patients With Any TEAEs During the Treatment Period Baseline to Day 14
时间窗: Baseline to Day 14
Number of participants who experienced at least one treatment-emergent adverse event (TEAE), defined as any adverse event with an onset date on or after the first dose of study drug and up to and including Day 14 post-baseline, regardless of causality. TEAEs are reported per standard MedDRA terminology and severity grading. This is a safety endpoint assessed in the safety population.
次要结局
- Secondary Safety Endpoint - 1 : Number of Patients With Any TEAEs During the Treatment Period Baseline to Day 28(Baseline to Day 28)
- Secondary Safety Endpoint -2 : Proportion of Patients With Any SAEs During the Study Baseline to Day 14(Baseline to Day 14)
- Secondary Safety Endpoint -3 : Number of Patients With Any SAEs During the Study Baseline to Day 28(Baseline to Day 28)
- Secondary Safety Endpoint -4 : Number of Patients With Any Drug-Related TEAE During the Study Baseline to Day 14(Baseline to Day 14)
- Secondary Safety Endpoint -5 : Number of Patients With Any Drug-Related TEAE During the Study Baseline to Day 28(Baseline to Day 28)
- Secondary Efficacy Endpoint -1 : Change in Derived PaO2/FiO2 Ratio From Baseline(Baseline to EOT(Day 14))
- Secondary Efficacy Endpoint -2 : Analysis of Number of Days Without Oxygen Use (Baseline to Day 14)(Baseline to Day 14)
- Secondary Efficacy Endpoint -3 : Analysis of Number of Days Without Oxygen Use (Baseline to Day 28)(Baseline to Day 28)
研究者
研究点 (9)
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