Trial document




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  DRKS00021152

Trial Description

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Title

COVID-19 Contact Study - Immunoreaction after possible SARS-CoV-2 / COVID-19 contact

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Trial Acronym

CoCo Study

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URL of the Trial

http://www.cocostudie.de

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Brief Summary in Lay Language

The aim of this study is to analyze the systemic immunoreaction after possible contact to SARS-CoV-2 exposure in medial personal longitudinally.
Primary aim is the analysis of incidence of seroconversion and possible conclusion on infection time by monitoring IgG development in individual healthcare workers over time and correlate it to symptoms.

In a second step an in depth analysis of immunoreactions on cellular level will be performed.

This study helps in assessing the individual risk of health care workers and to monitor the percentage severe or non-severe infections. It will help to assess the effectiveness of personal protective measures. These findings can be used in order to adapt recommendations in die future.

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Brief Summary in Scientific Language

SARS-CoV-2 infections can be asymptomatic or lead to severe manifestations of COVID-19. For March 2020 we expect a steep rise in cases at Hannover Medical School and infections of health care workers. It is currently unknown which departements face the highest risk.

This study has two phases. After informed consent phase 1 assesses longitudinally the seroconversion against SARS CoV-2 in departments with intensive patient contact, including COVID-19 patients, correlates to Symptoms and assesses the duration and kinetics of antibodyresponse in a limited cohort of health-care workers.

In addition biomaterials will be stored for broader immunological Analysis (PBMCs, antibodies, cytokindes).

The results of Phase 1 will enable an adaption of phase 2, if necessary.

Phase two is a vertical study on more employes of the university hospial and assessed the prevalence of SARS-CoV-2-IgG. This prevalence will be correlated to exposure data of certain departments.

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

Yes

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Description IPD sharing plan:

study plan, results

on demand

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Organizational Data

  •   DRKS00021152
  •   2020/04/07
  •   [---]*
  •   yes
  •   Approved
  •   8973_BO_K_2020, Ethikkommission der Medizinischen Hochschule Hannover
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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

  •   This study has two phases. After informed consent phase 1 assesses longitudinally the seroconversion against SARS CoV-2 in departments with intensive patient contact, including COVID-19 patients, correlates to Symptoms and assesses the duration and kinetics of antibodyresponse in a limited cohort of health-care workers.

    In addition biomaterials will be stored for broader immunological Analysis (PBMCs, antibodies, cytokindes).

    The results of Phase 1 will enable an adaption of phase 2, if necessary.

    Phase two is a vertical study on more employes of the university hospial and assessed the prevalence of SARS-CoV-2-IgG. This prevalence will be correlated to exposure data of certain departments.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Seroconversion (IgG) with quantitiative ELISA

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Secondary Outcome

Duration of immunoglobulin response
range of immunoglobulin response
respiratory symptoms
cellular immunoreaction
association to health care

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/04/05
  •   1000
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

health care worker

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Exclusion Criteria

no informed consent

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Addresses

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    • Medizinische Hochschule Hannover
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Mr.  Prof. Dr. med.  Georg  Behrens 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Mr.  Prof. Dr. med.  Georg  Behrens 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Deutsches Zentrum für Infektionsforschung
    • Inhoffenstr. 7
    • 38124  Braunschweig
    • Germany
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    • Novartis Pharma GmbH
    • Roonstr. 25
    • 90429  Nürnberg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Enrolling by invitation
  •   [---]*
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Trial Publications, Results and other Documents

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