Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Clinical complete response criteria
研究概览
简要总结
This is a Phase II pilot exploratory study designed to investigate if prophylactic treatment with short term steroids administered to high risk Covid-19 patient might prevent cytokine storm and progression to respiratory failure. High risk is defined based on serologic markers of inflammation that include abnormalities of Interleukin 6 (IL-6), Ferritin , D-dimer, Lactate Dehydrogenase (LDH), as well as lymphopenia and impaired O2 saturation prior to or on the 7th day of first symptom of Covid-19.
详细描述
To decrease the rate of progression to hypoxemic respiratory failure in high risk patients with Covid-19, treated with prophylactic steroids during the first phase of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •All patients diagnosed with Covid-19 will be registered on the study regardless pf their severity, but only those who meet high risk criteria will be treated with steroids. Those who don't meet the criteria will only be registered with no need to collect further data except baseline labs and CT Chest. They should sign the consent form and the data manager can collect the rest of the information.
- •Patients older than 18 years diagnosed with Covid-19 by Polymerase Chain Reaction (PCR) or by rapid serological test will be eligible. Cases who are Immunoglobulin G (IgG) positive but Immunoglobulin M (IgM) negative, will not be considered eligible unless they are positive for molecular PCR test. Eligible patients will be registered on study on or before 7 days from first onset of symptoms.
排除标准
- •Any patient with life expectancy < 1 month
- •Any patient who is oxygen dependent
- •Any patient with long standing history of severe Chronic Obstructive Pulmonary Disease (COPD)
- •Any patient who is chronically oxygen dependent because of previous existing lung disease
- •Anyone with severely uncontrolled diabetes despite adequate management
- •Anyone with active serious bacterial infection such as septicemia or pneumonia
- •Anyone receiving Tocilizumab (anti IL-6 therapy) or plasma therapy
- •Any patient already receiving steroids from another pre-existing illness
研究组 & 干预措施
Single Arm
- Patients will be admitted to a regular room in the hospital (not ICU)
- They will be monitored closely with vital signs every 4 hours to ensure their respiratory and cardiovascular status do not deteriorate.
- Methylprednisolone 80 mg IV bolus injection will be given daily x 5 days starting upon day 1 of admission to hospital.
干预措施: MethylPREDNISolone 80 Mg/mL Injectable Suspension (Drug)
结局指标
主要结局
Clinical complete response criteria
时间窗: 14 days
Clinical complete response criteria requires all the following: * No need for ventilatory support at any point * O2 Saturation of \>/= 93% by day 14 of therapy * Alive by day 28 from registration * CT chest with minimal or no evidence of disease by day 28 from registration
Clinical Partial Response criteria
时间窗: 14 days
Clinical Partial Response criteria require that 2 of the following be present by day 14 of therapy: * No need for ventilatory support at any point O2 saturation \> 93% bay day 14 from registration * CT chest stable to improve over baseline by day 28 from registration
次要结局
- Secondary response criteria(14 days)
研究者
Fernando Cabanillas
Medicine Doctor/Medical Director
Auxilio Mutuo Cancer Center