COVIDNCT04455451
Intensive Care Therapy of Covid-19 Disease in Germany
An observational study of COVID and ARDS, run by University Hospital Tuebingen at 27 sites in Germany.
Trial summary
Multi-center retrospective and prospective observational study of Covid-19 patients with severe or critical illness treated on a German ICU Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 2,054 participants
- Where
- 27 sitesGermany
- Study dates
- 6 Aug 2020to 30 Sep 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adults admitted for ICU therapy due to severe or critical Covid-19
Who may be able to join
- Age above 18 years
- Covid-19 disease (positive SARS-CoV-2 PCR)
Who cannot join
- -none
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Germany27 sites
RWTH Aachen - Department for operative Intensive Care Medicine and intermediate Care
Aachen
Zollernalbklinikum
Balingen
Charité Universitätsmedizin Berlin
Berlin
UH Bochum - Department for Anesthesiology and Intensive Care Medicine
Bochum
Universitätsklinikum Bonn
Bonn
Klinikum der Universität Witten/Herdecke - Köln / Klinik für Anästhesiologie und operative Intensivmedizin
Cologne
Universitätsklinikum Carl Gustav Carus Dresden
Dresden
Ev. Krankenhaus Bethesda Duisburg Klinik für Anästhesiologie und Intensivmedizin
Duisburg
Univerrsitätsklinikum Düsseldorf
Düsseldorf
Universitätsklinikum Essen
Essen
Universitätsklinikum Frankfurt
Frankfurt
University Hospital Freiburg - Department for Anesthesiology and Intensive Care Medicine
Freiburg im Breisgau
Universitätsklinikum Giessen Klinik für Anaesthesiologie und operative Intensivmedizin
Giessen
Universitätsmedizin Göttingen Klinik für Anästhesiologie
Göttingen
Universitätsklinikum Greifswald
Greifswald
Universitätsklinikum Halle
Halle
University Hospital Heidelberg - Department for Anesthesiologie and Intensive Care Medicine
Heidelberg
Universitätsklinikum des Saarlandes
Homburg/Saar
Universitätsklinikum Leipzig
Leipzig
UKSH Campus Lübeck - Department for Anesthesiology and Intensive Care Medicine
Lübeck
University Hospital Magdeburg - Department for Anesthesiology and Intensive Care Medicine
Magdeburg
Universitätsklinikum Marburg
Marburg
Technische Universität München
München
Oberschwabenklinik Ravensburg Klinik für Anästhesie-, Intensiv-, Notfall- und Schmerzmedizin
Ravensburg
University Hospital Tübingen - Department for Anesthesiology and Intensive Care Medicine
Tübingen
Universitätsklinikum Ulm
Ulm
Universitätsklinikum Würzburg Klinik und Poliklinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
Würzburg
About this study
Official title: Intensive Care Therapy of Covid-19 Disease in Germany an Multi-center Observational Study
Multi-center retrospective and prospective observational study of Covid-19 patients with severe or critical illness treated on a German ICU
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
ICU Mortality of patients
Measured: up to 150 days
Secondary outcomes (1)
ICU length of stay
Intensive care unit length of stay
Measured: up to 150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start6 Aug 2020
- Primary completion15 Aug 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Other
- Enrolment
- 2,054 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Rosenberger, MD, PhD, Principal investigator, University Hospital TuebingenHarry Magunia, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455451
- Sponsor's protocol ID
- DCIR
- Status last verified
- Sep 2021
- First submitted
- 1 Jul 2020
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Magunia H, Lederer S, Verbuecheln R, Gilot BJ, Koeppen M, Haeberle HA, Mirakaj V, Hofmann P, Marx G, Bickenbach J, Nohe B, Lay M, Spies C, Edel A, Schiefenhovel F, Rahmel T, Putensen C, Sellmann T, Koch T, Brandenburger T, Kindgen-Milles D, Brenner T, Berger M, Zacharowski K, Adam E, Posch M, Moerer O, Scheer CS, Sedding D, Weigand MA, Fichtner F, Nau C, Pratsch F, Wiesmann T, Koch C, Schneider G, Lahmer T, Straub A, Meiser A, Weiss M, Jungwirth B, Wappler F, Meybohm P, Herrmann J, Malek N, Kohlbacher O, Biergans S, Rosenberger P. Machine learning identifies ICU outcome predictors in a multicenter COVID-19 cohort. Crit Care. 2021 Aug 17;25(1):295. doi: 10.1186/s13054-021-03720-4.
PubMed 34404458
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Care Therapy of Covid-19 Disease in Germany an Multi-center Observational Study
- ClinicalTrials.gov ID
- NCT04455451
- Acronym / sponsor ID
- DCIR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,054 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 2 Jul 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.
Multi-center retrospective and prospective observational study of Covid-19 patients with severe or critical illness treated on a German ICU
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults admitted for ICU therapy due to severe or critical Covid-19
Key inclusion criteria (2 listed)
- Age above 18 years
- Covid-19 disease (positive SARS-CoV-2 PCR)
Key exclusion criteria (1 listed)
- -none
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
Mortality
Time frame: up to 150 days
ICU Mortality of patients
1 secondary outcome
ICU length of stay
Time frame: up to 150 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Derived from this study: PubMed 34404458Magunia H, Lederer S, Verbuecheln R, Gilot BJ, Koeppen M, Haeberle HA, Mirakaj V, Hofmann P, Marx G, Bickenbach J, Nohe B, Lay M, Spies C, Edel A, Schiefenhovel F, Rahmel T, Putensen C, Sellmann T, Koch T, Brandenburger T, Kindgen-Milles D, Brenner T, Berger M, Zacharowski K, Adam E, Posch M, Moerer O, Scheer CS, Sedding D, Weigand MA, Fichtner F, Nau C, Pratsch F, Wiesmann T, Koch C, Schneider G, Lahmer T, Straub A, Meiser A, Weiss M, Jungwirth B, Wappler F, Meybohm P, Herrmann J, Malek N, Kohlbacher O, Biergans S, Rosenberger P. Machine learning identifies ICU outcome predictors in a multicenter COVID-19 cohort. Crit Care. 2021 Aug 17;25(1):295. doi: 10.1186/s13054-021-03720-4.
- Study Landing PageLink provided by the sponsor.
- 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.
Peter Rosenberger, MD, PhD principal investigator
University Hospital Tuebingen
Harry Magunia, MD principal investigator
University Hospital Tuebingen
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and ARDS, run by University Hospital Tuebingen at 27 sites 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: up to 150 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04455451, which also lists 1 linked publication.
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 12 Jan 2022.