COVIDCOVIDHLHNCT04347460
Establishing a COVID-19 Prospective Cohort for Identification of Secondary HLH
An observational study of COVID, run by Technical University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 27 Mar 2020to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: We will recruit patients with COVID 19 interstital pneumonia with need of ICU treatment at the Klinikum rechts der Isar.
Who may be able to join
- 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
Who cannot join
- not fulfilling the inclusion criteria
- missing written and informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of nephrology, Klinikum rechts der Isar
München, Bavaria, 81675
Christoph Schmaderer, M.D., 0049-89-4140 ext. 5231, christoph.schmaderer@mri.tum.de
Georg Lorenz, M.D., 0049-89-4140 ext. 5231, georg.lorenz@mri.tum.de
About this study
Official title: Establishing a Covid-19 Prospective Cohort to Document Cases of Secondary Hemophagocytic Lymphohistiocytosis (sHLH, Synonoums to Macrophage Activation Syndrome)
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.
Read the 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.
- Conditions
- COVID
- Keywords
- MAS, HLH, COVID
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID 19 | Patients requiring ICU treatment due to severe COVID 19 interstitial pneumonia or otherwise COVID-19 related disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
Measured: assessed within 15 days post ICU-admission
Secondary outcomes (3)
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
Measured: assesed on study day 15
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
Measured: assesed on study day 29
immunophenotpye
characterize immune cell populations
Measured: in the first days after admission to the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start27 Mar 2020
- Primary completion1 Jul 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Schmaderer, M.D., Principal investigator, Department of Nephrology, TUM Medical School, Klinikum rechts der Isar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347460
- Sponsor's protocol ID
- 161/20 S
- Acronym
- COVIDHLH
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Covid-19 Prospective Cohort to Document Cases of Secondary Hemophagocytic Lymphohistiocytosis (sHLH, Synonoums to Macrophage Activation Syndrome)
- ClinicalTrials.gov ID
- NCT04347460
- Acronym / sponsor ID
- COVIDHLH / 161/20 S
- Conditions
- COVID
- Keywords
- MAS, HLH, COVID
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID 19 | – | –Patients requiring ICU treatment due to severe COVID 19 interstitial pneumonia or otherwise COVID-19 related disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- We will recruit patients with COVID 19 interstital pneumonia with need of ICU treatment at the Klinikum rechts der Isar.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- not fulfilling the inclusion criteria
- missing written and informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of sHLH as determined by expert chart review by two independent reviewers
Time frame: 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
Determine the incidence of patients fulfilling HLH criteria in Covid 19 viral infection
Time frame: in the first week after admission to the ICU
Calculate HScore in all recruited patients
Determine the incidence of patients fulfilling modified 2004 HLH diagnostic criteria (Ferritin > 10000 μg/L) in Covid 19 viral infection
Time frame: in the week after admission to the ICU
Calculate modified 2004 HLH diagnostic criteria in all study participants
Characterization and incidence of the hyper-inflammatory state in COVID-19
Time frame: 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)
3 secondary outcomes
all cause mortality assesed on day 15
Time frame: assesed on study day 15
all cause mortality assesed on day 29
Time frame: assesed on study day 29
immunophenotpye
Time frame: in the first days after admission to the ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Schmaderer, M.D. principal investigator
Department of Nephrology, TUM Medical School, Klinikum rechts der Isar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Schmaderer, M.D. (0049-89-4140 ext. 5231, christoph.schmaderer@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of sHLH as determined by expert chart review by two independent reviewers (time frame: in the first week after admission to the ICU). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.