Establishing a Covid-19 Prospective Cohort to Document Cases of Secondary Hemophagocytic Lymphohistiocytosis (sHLH, Synonoums to Macrophage Activation Syndrome)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COVID
- Sponsor
- Technical University of Munich
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Presence of sHLH as determined by expert chart review by two independent reviewers
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •not fulfilling the inclusion criteria
- •missing written and informed consent
Outcomes
Primary Outcomes
Presence of sHLH as determined by expert chart review by two independent reviewers
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Secondary Outcomes
- 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)