Trial document

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DRKS-ID: DRKS00021145

Trial Description

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Title

Lean European Open Survey on
SARS-CoV-2 (COVID-19)

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Trial Acronym

LEOSS

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URL of the Trial

https://leoss.net/

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Brief Summary in Lay Language

The current Severe Acute Respiratory Syndrome Coronavirus II (SARS-CoV-2) pandemic is a major challenge for medical professionals worldwide, with a daily increase of new infections. There is an urgent need to record confirmed SARS-CoV-2 cases uniformly in order to establish an evidence base for best practice in clinical management of patients with SARS-CoV-2 infection.
We initiated the Lean European Open Survey on SARS-CoV-2 (LEOSS) project, a prospective European multi-center cohort study, to get more in-depth knowledge about the epidemiology and clinical course of patients infected with SARS-CoV-2. Our goal is to establish a quick and simple register that allows anonymous documentation of patients, with the objective to identify independent predictors of outcome in patients with diagnosed infection by SARS-CoV-2. The data will be available for collaborating scientists and results will be publicly available on a regular bases on the project website https://leoss.net/.

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Brief Summary in Scientific Language

The current Severe Acute Respiratory Syndrome Coronavirus II (SARS-CoV-2) pandemic is a major challenge for medical professionals worldwide, with a daily increase of new infections. A uniform recording of confirmed SARS-CoV-2 cases can provide information on successful treatment and prevention of severe disease progression. Our project Lean European Open Survey on SARS-CoV-2 (LEOSS) creates an infrastructure for an European-wide documentation of patients with a SARS-CoV-2 infection. The project develops a simple, quick and anonymous documentation. The overall goal is to identify independent predictors of outcome in patients with diagnosed infection by SARS-CoV-2. The data will be available for collaborating scientists and results will be publicly available on a regular bases on the project website https://leoss.net/.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

We will present descriptive statistics on the included cases, socio-demographic characteristics and clinical course daily/weekly on our website https://leoss.net/. Furthermore, results of the calculated correlations with treatment strategies, laboratory values and the severity of disease progression and event-time analyses will be presented.

The study protocol and a description of the eCRF will be provided.

An anonymised data set is made available to the cooperation partners in a password-protected manner. A selected part of the entire anonymised data set (e.g. statistics on cases in regions/hospitals of the cooperating centres) will be available to all cooperating centres. Access to the data is regulated by a data use and access policy.

Since the anonymous data set will be passed on to the research community, it will not be possible to keep control over the analyses carried out by international researchers. We will inform via our website that secondary analyses must justify IRB approval based on local laws and regulations.

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Organizational Data

DRKS-ID: DRKS00021145
Date of Registration in DRKS: 2020/04/08
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 20-600, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main

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Secondary IDs

[---]*

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Health Condition or Problem studied

ICD10: U07.1 - Emergency use of U07.1

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Interventions/Observational Groups

Arm 1: Patients with confirmed SARS-CoV-2 infection by PCR diagnosis from nasopharynx, oropharynx, stool, or blood. Rapid tests are an acceptable alternative.
Within the framework of LEOSS, data on the therapy and the course of treatment of patients infected with SARS-CoV-2 will be documented. The resulting registry will enable the analysis of important questions regarding SARS-CoV-2. Within the scope of the project, no study conditional interventions will be carried out.

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Characteristics

Study Type: Non-interventional
Study Type Non-Interventional: Observational study
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Other
Assignment: Single (group)
Phase: N/A
Off-label Drug use: N/A

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Primary Outcome

To identify independent predictors of outcome in patients with diagnosed infection by SARS-CoV-2.

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Secondary Outcome

1) To assess the incidence of complicated and critical infection by SARS-CoV-2
2) To assess potential risk factors of complicated and critical infection by SARS-CoV-2
3) To assess clinical and sociodemographic characteristics of patients with SARS-CoV-2 infection (descriptive)
4) Assessment of the temporal relationship between the severity of SARS-CoV-2 infection and death
5) Assessment of regional differences in management and clinical outcome (descriptive)
6) Monitoring different trends over time (symptoms, incidence) (descriptive)
7) Estimation of direct health care costs based on length of stay, time on ICU, time with mechanical ventilation, time on ECMO (descriptive)
8) Cost utilization based on coded DRG and reimbursement (descriptive)
9) Assessment of the relationship between SARS-CoV-2 and the health economic burden in terms of direct treatment costs incurred during hospitalization (descriptive)
10) To describe the clinical pattern of disease: Sequence and reversibility of symptoms (descriptive), sequence of radiographic imaging findings (descriptive), sequence of laboratory lab results and patterns of disease severity (descriptive, multivariable binary logistic regression model), sequence of virus detection and quantity in various bodily fluids and samples (descriptive), immunological / inflammatory features of severe infection (descriptive, multivariable binary logistic regression model)

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Countries of Recruitment

BE: Belgium
DE: Germany
FR: France
IT: Italy
IE: Ireland
PT: Portugal
ES: Spain
AT: Austria
IS: Iceland
CH: Switzerland
UK: United Kingdom

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Locations of Recruitment

Medical Center Uniklinik Köln, Köln
Medical Center Unklinik Frankfurt, Frankfurt a.M.
University Medical Center Clinic for Infectious Diseases University Clinical Hospital Mostar, Mostar
Medical Center Klinikum Leverkusen, Leverkusen
University Medical Center Uniklinik Schleswig-Holstein, Schleswig-Holstein
Medical Center Carl-Thiem-Klinikum Cottbus, Cottbus
University Medical Center Uniklinik Jena, Jena
University Medical Center LMU Klinikum München, München
University Medical Center Uniklinik Johannes Gutenberg Mainz, Mainz
University Medical Center Uniklinik Regensburg, Regensburg
University Medical Center Uniklinik Frankfurt, Frankfurt a.M.
University Medical Center Uniklinik Freiburg, Freiburg
University Medical Center Uniklinik Bochum, Bochum
University Medical Center Uniklinik Wuppertal, Wuppertal
University Medical Center Uniklinik Bonn, Bonn
Medical Center Bethesda Krankenhaus Bergedorf, Hamburg
Medical Center Klinikum Nürnberg, Nürnberg
Medical Center St. Barbara - Klinik Hamm, Hamm
Medical Center St. Josefs-Hospital Wiesbaden, Wiesbaden
Medical Center Evangelisches Stadtkrankenhaus Saarbrücken, Saarbrücken
University Medical Center Uniklinik rechts der Isar der Technischen Universität München, München
Medical Center Kliniken Südostbayern, Traunstein
University Medical Center Uniklinik Würzburg, Würzburg
University Medical Center Uniklinik Minden, Minden
University Medical Center Uniklinik Erlangen, Erlangen
Medical Center Nephrologisches Zentrum Villingen-Schwenningen, Villingen-Schwenningen
University Medical Center Marien Hospital, Ruhr Universität Bochum, Bochum
Medical Center Elblandklinik um Riesa, Riesa
University Medical Center Uniklinik Carl-Gustav-Carus Dresden, Dresden
Medical Center Charité, Berlin
University Medical Center Medizinische Hochschule Hannover, Hannover
Medical Center Malteser Krankenhaus Flensburg, Flensburg
University Medical Center Uniklinik Aachen, Aachen
Medical Center Petrus Krankenhaus Wuppertal, Wuppertal
Medical Center Klinikum Ernst von Bergmann, Potsdam
other Robert Koch Institut, Berlin
Medical Center Elisabeth-Krankenhaus Essen, Essen
Doctor's Practice Berlin
Medical Center Tropenklinik Paul-Lechler-Krankenhaus, Tübingen
other Institut für Medizinische Informatik, Westfälische Wilhelms-Universität Münster, Münster
University Medical Center Uniklinik Leipzig, Leipzig
University Medical Center university hospital Joseo Trueta , Girona

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2020/03/16
Target Sample Size: 20000
Monocenter/Multicenter trial: Multicenter trial
National/International: International

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: no minimum age
Maximum Age: no maximum age

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Additional Inclusion Criteria

Patients with confirmed SARS-CoV-2 infection by PCR diagnosis from nasopharynx, oropharynx, stool, or blood. Rapid tests are an acceptable alternative.

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Exclusion Criteria

The study will be governed, announced, and disseminated via ESCMID and other channels across Europe. However, treatment in another country is not a formal exclusion criterion.

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Addresses

Primary Sponsor
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- Deutsches Zentrum für Infektionsforschung (DZIF) e. V.
- Inhoffenstr. 7
- 38124 Braunschweig
- Germany
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- Telephone: 0531 61811152
- Fax: [---]*
- E-mail: office at dzif.de
- URL: [---]*
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Contact for Scientific Queries
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- University Hospital of Cologne, Faculty of Medicine and University Hospital Cologne, Department I for Internal Medicine, Cologne, Germany
- Mr. Prof. Jörg Janne Vehreschild
- Herderstraße 52-54
- 50931 Köln
- Germany
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- Telephone: +49 221 478-88794
- Fax: +49 221 478-85504
- E-mail: janne.vehreschild at uk-koeln.de
- URL: http://www.infektiologiekoeln.de
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Contact for Public Queries
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- University Hospital of Cologne, Faculty of Medicine and University Hospital Cologne, Department I for Internal Medicine, Cologne, Germany
- Mr. Prof. Jörg Janne Vehreschild
- Herderstraße 52-54
- 50931 Köln
- Germany
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- Telephone: +49 221 478-88794
- Fax: +49 221 478-85504
- E-mail: janne.vehreschild at uk-koeln.de
- URL: http://www.infektiologiekoeln.de
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Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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- Deutsches Zentrum für Infektionsforschung (DZIF)
- Inhoffenstr. 7
- 38124 Braunschweig
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: office at dzif.de
- URL: [---]*
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Private sponsorship (foundations, study societies, etc.)
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- Willy Robert Pitzer Stiftung
- Myliusstraße 30
- 60323 F Frankfurt am Main
- Germany
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- Telephone: 069 24706941
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.pitzer-Stiftung.de
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Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

Approval of ethics comm. (mandatory for transfer to Studybox): Ethikvotum Frankfurt
trial protocol (mandatory for transfer to Studybox): Studienprotokoll LEOSS
Further trial documents: Übersicht der erhobenen Parameter

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* This entry means the parameter is not applicable or has not been set.