Trial document




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  DRKS00021145

Trial Description

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Title

Lean European Open Survey on
SARS-CoV-2 infected patients (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 on a regular base 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.

In the context of an open-science approach, two different datasets will be made available to the research community under certain conditions. Both will receive a second layer of anonymization by aggregation and omission of categories with low numbers and/or increased risk for re-identification. The latest statistics as well as a reduced anonymized public use file (PUF) will be publicly available on https://www.leoss.net. An anonymized scientific use file (SUF) will be available to the cooperation partners for more in-depth analyses, for specific research questions a data set containing the respective variables of interests while ensuring anonymity will be provided. Transmission of data will be carried out in a secure download with two-factor authentication.

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Organizational Data

  •   DRKS00021145
  •   2020/04/08
  •   [---]*
  •   yes
  •   Approved
  •   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

  •   U07.1 -  Emergency use of U07.1
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Interventions/Observational Groups

  •   Patients with confirmed SARS-CoV-2 infection by PCR diagnosis from nasopharynx, oropharynx, bronchoalveaolar lavage, 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

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   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

  •   Belgium
  •   Germany
  •   Latvia
  •   Italy
  •   Bosnia and Herzegovina
  •   Spain
  •   Austria
  •   Turkey
  •   Switzerland
  •   United Kingdom
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Locations of Recruitment

  • University Medical Center 
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  • Doctor's Practice 
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  • Medical Center 
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  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/03/16
  •   20000
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

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

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Exclusion Criteria

Confirmed SARS-CoV-2 infection without basic medical information including an initial blood sample and/or without any follow-up data.

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Addresses

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    • Deutsches Zentrum für Infektionsforschung (DZIF) e. V.
    • Inhoffenstr. 7
    • 38124  Braunschweig
    • Germany
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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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    • 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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Sources of Monetary or Material Support

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    • Deutsches Zentrum für Infektionsforschung (DZIF)
    • Inhoffenstr. 7
    • 38124  Braunschweig
    • Germany
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    • Willy Robert Pitzer Stiftung
    • Myliusstraße 30
    • 60323 F  Frankfurt am Main
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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