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

Sponsor
Technische Universität München (Other)
Overall Status
Unknown status
CT.gov ID
NCT04347460
Collaborator
(none)
20
Enrollment
1
Location
5.2
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Establishing a Covid-19 Prospective Cohort to Document Cases of Secondary Hemophagocytic Lymphohistiocytosis (sHLH, Synonoums to Macrophage Activation Syndrome)
    Actual Study Start Date :
    Mar 27, 2020
    Anticipated Primary Completion Date :
    Jul 1, 2020
    Anticipated Study Completion Date :
    Aug 31, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    COVID 19

    Patients requiring ICU treatment due to severe COVID 19 interstitial pneumonia or otherwise COVID-19 related disease

    Outcome Measures

    Primary Outcome Measures

    1. Presence of sHLH as determined by expert chart review by two independent reviewers [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

    2. Determine the incidence of patients fulfilling HLH criteria in Covid 19 viral infection [in the first week after admission to the ICU]

      Calculate HScore in all recruited patients

    3. Determine the incidence of patients fulfilling modified 2004 HLH diagnostic criteria (Ferritin > 10000 μg/L) in Covid 19 viral infection [in the week after admission to the ICU]

      Calculate modified 2004 HLH diagnostic criteria in all study participants

    4. Characterization and incidence of the hyper-inflammatory state in COVID-19 [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 Outcome Measures

    1. all cause mortality assesed on day 15 [assesed on study 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

    2. all cause mortality assesed on day 29 [assesed on study 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

    3. immunophenotpye [in the first days after admission to the ICU]

      characterize immune cell populations

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of nephrology, Klinikum rechts der Isar München Bavaria Germany 81675

    Sponsors and Collaborators

    • Technische Universität München

    Investigators

    • Principal Investigator: Christoph Schmaderer, M.D., Department of Nephrology, TUM Medical School, Klinikum rechts der Isar

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Technische Universität München
    ClinicalTrials.gov Identifier:
    NCT04347460
    Other Study ID Numbers:
    • 161/20 S
    First Posted:
    Apr 15, 2020
    Last Update Posted:
    Apr 15, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Technische Universität München
    MAS
    HLH
    COVID

    Study Results

    No Results Posted as of Apr 15, 2020