Early Treatment of Cytokine Storm Syndrome in Covid-19
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Subjects Discharged From the Hospital Alive and Without the Need for Mechanical Ventilation.
研究概览
简要总结
This proposal addresses the problem of preventing the very high mortality and morbidity associated with the development of Cytokine Storm Syndrome (CSS) associated respiratory failure in Covid-19 infection.
详细描述
The first aim of this project is to determine whether rapidly assayed early clinical laboratory markers of CSS (eCSS: leucopenia, lymphopenia, and elevated ferritin, d-dimer, LDH, CRP, and AST/ALT) in patients admitted to the hospital with respiratory compromise in the setting of Covid-19 infection can accurately identify patients with CSS as defined by validated CSS case definitions (H-Score, aHLH-2004). Confirmation of eCSS predictive of evolving CSS will identify patients at risk for rapid deterioration of lung function and inform early initiation of treatment for CSS. Genotyping studies will also be performed on patients with confirmed CSS to determine whether perforin pathway mutations commonly present in CSS associated with other disorders are present. The second aim is to determine whether early treatment with rhIL-1Ra (anakinra) in patients admitted to the hospital with markers of CSS improves or prevents deterioration of respiratory dysfunction and prevents the development of respiratory failure requiring mechanical ventilation.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Investigator, care provider, and participant 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
- •18 years old or older
- •Molecular (pcRNA) diagnosis of SARS-CoV-2 infection
- •Chest imaging studies consistent with Covid-19 pneumonia
- •Hyperferritinemia (>700 ng/ml)
- •History of fever >38 degrees C
- •Any three of the following:
- •Elevated d-dimer (> 500 ng/ml)
- •thrombocytopenia (< 130,000/mm3)
- •leucopenia (WBC <3500/mm3) or lymphopenia (<1000/mm3)
- •elevated AST or ALT (> 2X ULN)
- •elevated LDH (> 2X ULN)
- •CRP > 100 mg/L
排除标准
- •Participation in other investigational treatment protocols for Covid-19 infection
- •Culture confirmed active bacterial infection requiring antibiotic therapy
- •On mechanical ventilation
- •Previous known hypersensitivity reaction to anakinra
- •Previous known hypersensitivity reaction to E Coli derived proteins
- •Pregnant or breast-feeding females
研究组 & 干预措施
Anakinra Group
The active treatment group will receive anakinra 100 mg subcutaneously every 6 hours for period of 10 days. For subjects meeting complete response criteria at 5 days, dosing will be decreased to 100 mg twice daily for the remaining 5 days.
干预措施: Anakinra (Drug)
Control Group
The control group will receive normal saline placebo subcutaneously every 6 hours for period of 10 days. For subjects meeting complete response criteria at 5 days, dosing will be decreased to twice daily for the remaining 5 days.
干预措施: Normal saline (Drug)
结局指标
主要结局
Subjects Discharged From the Hospital Alive and Without the Need for Mechanical Ventilation.
时间窗: Variable up to Day 28
Percentage of subjects discharged from hospital alive and who did not require intubation and mechanical ventilation
次要结局
- Percentage of Subjects Without Increase in Oxygen Requirement and no Increase in Oxygen Delivery/Respiratory Support Measures After 48 Hours.(Day 2 (48 hours)-Day 10 (240 hours))
- Percentage of Subjects With Resolution of Laboratory Markers of Cytokine Storm Syndrome(Day 10)
- Percentage of Subjects With 25% Change (Decrease) in Cytokine Storm Markers at 48-72 Hours After Dosing With Study Agent(48 hours after taking initial dose of anakinra/placebo)
- Patients Requiring Minimal Oxygen Support at Day 10(0-10 days)
- Percentage of Subjects Who Develop Bacterial or Fungal or Non-Covid-19 Viral Infection(Day 0-28)
- Absence of Supplemental Oxygen Requirement at Day 10(0-10 Days)
研究者
W Winn Chatham
Principal Investigator
University of Alabama at Birmingham