Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT04347460
Status:
UNKNOWN
Last Update Posted:
2020-04-15
First Post:
2020-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishing a COVID-19 Prospective Cohort for Identification of Secondary HLH
Sponsor:
Technical University of Munich
Organization:
Study Overview
Official Title:
Establishing a Covid-19 Prospective Cohort to Document Cases of Secondary Hemophagocytic Lymphohistiocytosis (sHLH, Synonoums to Macrophage Activation Syndrome)
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVIDHLH
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: