Establishing a Covid-19 Prospective Cohort to Document Cases of Secondary Hemophagocytic Lymphohistiocytosis (sHLH, Synonoums to Macrophage Activation Syndrome)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Presence of sHLH as determined by expert chart review by two independent reviewers
研究概览
简要总结
SARS-CoV2 has become a pandemic disease putting an enormous burden on health care systems around the world. A considerable amount of patients require intensive care treatment for Covid-19 associated pneumonia. At this point there is no specific treatment, apart from supportive intensive care treatment protocols for severe COVID-19 disease.The latest reports describe massive hyperinflammation in some of the severe COVID-19 patients, which is not a typical finding in virus associated pneumonia. The H-score and the modified HLH 2004 score offer diagnostic tools, that help establishing the diagnosis of HLH. Even more important is the expert clinical judgment to establish the diagnosis of sHLH.
详细描述
SARS-CoV2 has become a pandemic disease putting an enormous burden on health care systems around the world. The course of disease is relatively mild in most of the patients, but there is a considerable amount of patients that require intensive care treatment for Covid-19 associated pneumonia. At this point there is no specific treatment, apart from supportive intensive care treatment protocols for severe COVID-19 disease.The latest reports describe massive hyperinflammation in some of the severe COVID-19 patients. The H-score and the modified HLH 2004 score offer diagnostic tools, that helps establishing the diagnosis of HLH. Moreover expert clinical judgment is key to establish a diagnosis of sHLH. Still, so far no systematic analysis has been carried out answering the question as to whether or not these patients suffer from secondary HLH and could potentially benefit from immunomodulatory drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age > 17a
- •diagnosis of SARS CoV 2 by PCR testing
- •Hospitalized due to clinical severity of the disease
- •written and informed consent or consent of the family
- •GFR<30 is not an exclusion criterion
排除标准
- •not fulfilling the inclusion criteria
- •missing written and informed consent
结局指标
主要结局
Presence of sHLH as determined by expert chart review by two independent reviewers
时间窗: in the first week after admission to the ICU
blinded chart review by a hematooncologist and a rheumatologist having expert experience in HLH diagnosis and treatment
Determine the incidence of patients fulfilling modified 2004 HLH diagnostic criteria (Ferritin > 10000 μg/L) in Covid 19 viral infection
时间窗: in the week after admission to the ICU
Calculate modified 2004 HLH diagnostic criteria in all study participants
Determine the incidence of patients fulfilling HLH criteria in Covid 19 viral infection
时间窗: in the first week after admission to the ICU
Calculate HScore in all recruited patients
Characterization and incidence of the hyper-inflammatory state in COVID-19
时间窗: assessed within 15 days post ICU-admission
characterized by sIL-2, Ferritin, Il-6, CRP, PCT and aberrant cellular activation (differential blood count and immunophenotypic analysis)
次要结局
- all cause mortality assesed on day 29(assesed on study day 29)
- immunophenotpye(in the first days after admission to the ICU)
- all cause mortality assesed on day 15(assesed on study day 15)