Establishing a COVID-19 Prospective Cohort for Identification of Secondary HLH

COVID Clinical Trial

— COVIDHLH  

Official title:

Establishing a Covid-19 Prospective Cohort to Document Cases of Secondary Hemophagocytic Lymphohistiocytosis (sHLH, Synonoums to Macrophage Activation Syndrome)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04347460
• Other study ID #: 161/20 S
• Status: Recruiting
• Start date: March 27, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: April 2020
• Source: Technische Universität München
• Contact: Christoph Schmaderer, M.D.
• Phone: 0049-89-4140
• Email: christoph.schmaderer[@]mri.tum.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 31, 2020
• Est. primary completion date: July 1, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID

Locations

Country	Name	City	State
Germany	Department of nephrology, Klinikum rechts der Isar	München	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of sHLH as determined by expert chart review by two independent reviewers	blinded chart review by a hematooncologist and a rheumatologist having expert experience in HLH diagnosis and treatment	in the first week after admission to the ICU
Primary	Determine the incidence of patients fulfilling HLH criteria in Covid 19 viral infection	Calculate HScore in all recruited patients	in the first week after admission to the ICU
Primary	Determine the incidence of patients fulfilling modified 2004 HLH diagnostic criteria (Ferritin > 10000 µg/L) in Covid 19 viral infection	Calculate modified 2004 HLH diagnostic criteria in all study participants	in the week after admission to the ICU
Primary	Characterization and incidence of the hyper-inflammatory state in COVID-19	characterized by sIL-2, Ferritin, Il-6, CRP, PCT and aberrant cellular activation (differential blood count and immunophenotypic analysis)	assessed within 15 days post ICU-admission
Secondary	all cause mortality assesed on day 15	vital status of patients will be assesed by clinical records or phone calls to patient or relatives or other hospitals involved in the care of the patient	assesed on study day 15
Secondary	all cause mortality assesed on day 29	vital status of patients will be assesed by clinical records or phone calls to patients or relatives or other hospitals involved in the care of the patient	assesed on study day 29
Secondary	immunophenotpye	characterize immune cell populations	in the first days after admission to the ICU