Tociluzumab for Cytokine Release Syndrome With SARS-CoV-2: An Open-Labeled, Randomized Phase 3 Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- 7-day length of invasive mechanical ventilation (MV)
研究概览
简要总结
This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.
详细描述
PRIMARY OBJECTIVE:
I. To decrease the length of invasive mechanical ventilation (MV) and rate of 30-day mortality from CRS due to SARS-CoV-2.
SECONDARY OBJECTIVES:
I. To decrease the rates of intensive care unit (ICU) transfer. II. To decrease the rate of invasive mechanical ventilation (MV). III. To decrease the length of ICU stay. IV. To decrease the rate of tracheostomy. V. Safety and efficacy of tociluzumab. VI. Biomarker assessment for response.
OUTLINE: Patients are randomized to 1 of 2 arms.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis with SARS-CoV-2 by the currently available assays (Food and Drug Administration [FDA] approved)
- •Should be hospitalized and exhibit at least one of the following predictors of mortality
- •Age >= 65 years
- •Current smoker (smoked >= 100 cigarettes in life and actively smoking)
- •Chronic obstructive pulmonary disease (COPD)
- •Hypertension
- •Coronary artery disease
- •Cerebrovascular accident (CVA)
- •Chronic renal disease (creatinine of >= 2 mg/dl)
- •Patients that have C-reactive protein (CRP) >= 10 mg/L
- •D-dimer >= 0.5 mg/L
- •Procalcitonin >= 0.5 mg/L
- •Lactate dehydrogenase (LDH) >= upper limit of normal (ULN)
- •Patients or authorized family member willing to sign informed consent to participate in this study
排除标准
- •Pregnant or lactating women
- •Hypersensitivity to tocilizumab
- •Patients or authorized family member unwilling to sign informed consent to participate in this study
- •Uncontrolled tuberculosis, or any uncontrolled fungal infection (eg: candidemia)
结局指标
主要结局
7-day length of invasive mechanical ventilation (MV)
时间窗: Up to 7 days
The 7-day length of invasive MV for each arm will be estimated with 95% confidence intervals (CIs) using the exact binomial distribution. Their difference by the arms will be tested by Cochran-Mantel-Haenszel (CMH) test stratified by the age group and Sequential Organ Failure Assessment (SOFA) score at significance level of 0.05.
30-day mortality rate
时间窗: Up to 30-day after randomization
Defined as death within 30-day after randomization. The 30-day mortality rate for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
次要结局
- Length of hospital stay(Up 2 years)
- Rate of invasive mechanical ventilation(Up to 2 years)
- Rate of intensive care (ICU) transfer(Up to 2 years)
- Rate of tracheostomy(Up to 2 years)
- Length of ICU stay(Up to 2 years)
研究者
Ajay Nooka
Principal Investigator
Emory University