Clinical trial NCT04347460: Establishing a COVID-19 Prospective Cohort for Identification of Secondary HLH
Official title: Establishing a Covid-19 Prospective Cohort to Document Cases of Secondary Hemophagocytic Lymphohistiocytosis (sHLH, Synonoums to Macrophage Activation Syndrome)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Keywords: MAS
HLH
COVID
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will recruit patients with COVID 19 interstital pneumonia with need of ICU treatment at the Klinikum rechts der Isar.

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.

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

Primary outcomes:
measure: Presence of sHLH as determined by expert chart review by two independent reviewers
timeFrame: in the first week after admission to the ICU
measure: Determine the incidence of patients fulfilling HLH criteria in Covid 19 viral infection
timeFrame: in the first week after admission to the ICU
measure: Determine the incidence of patients fulfilling modified 2004 HLH diagnostic criteria (Ferritin > 10000 μg/L) in Covid 19 viral infection
timeFrame: in the week after admission to the ICU
measure: Characterization and incidence of the hyper-inflammatory state in COVID-19
timeFrame: assessed within 15 days post ICU-admission
Secondary outcomes:
measure: all cause mortality assesed on day 15
timeFrame: assesed on study day 15
measure: all cause mortality assesed on day 29
timeFrame: assesed on study day 29
measure: immunophenotpye
timeFrame: in the first days after admission to the ICU
Other outcomes:
Locations:
city: München
country: Germany
facility: Department of nephrology, Klinikum rechts der Isar
state: Bavaria
Study officials:
affiliation: Department of Nephrology, TUM Medical School, Klinikum rechts der Isar
name: Christoph Schmaderer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: