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

NCT04347460 | Unknown DMC

• 1 other identifier: 161/20 S
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID

Keywords

MAS; HLH; COVID

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• all cause mortality assesed on day 15

  assesed on study day 15

• all cause mortality assesed on day 29

  assesed on study day 29

• immunophenotpye

  in the first days after admission to the ICU

Study Arms (1)

COVID 19

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• missing written and informed consent

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Department of nephrology, Klinikum rechts der Isar

München, Bavaria, 81675, Germany

RECRUITING

Study Officials

• Christoph Schmaderer, M.D.

  Department of Nephrology, TUM Medical School, Klinikum rechts der Isar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Schmaderer, M.D.

CONTACT

0049-89-4140; christoph.schmaderer@mri.tum.de

Philipp Moog, M.D.

CONTACT

0049-89-4140; philipp.moog@mri.tum.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 15, 2020
• Study Start: March 27, 2020
• Primary Completion: July 1, 2020
• Study Completion: August 31, 2020
• Last Updated: April 15, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)