Trial document





This trial has been registered retrospectively.
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  DRKS00021672

Trial Description

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Title

Investigation of factors that may influence the course of a SARS-CoV-2 infection (COVID-19): A study of the University Medical Center Greifswald

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Trial Acronym

COVER-Studie

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URL of the Trial

http://www.medizin.uni-greifswald.de/pharmako/corona/

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Brief Summary in Lay Language

We aim to investigate the course of SARS-CoV-2 infection in relation to possible risk factors including previous diseases, medication taken, age, gender and additional factors.

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Brief Summary in Scientific Language

We aim to collect systematically information about factors that may affect the course of SARS-CoV-2 infection. The factors studied include age, pre-existing conditions, medications taken, therapeutic approaches in case of hospitalization. These factors will be tested for association with the clinical course of the infection to identify risk or protective factors.

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

Yes

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Description IPD sharing plan:

All the trial data will be stored for 10 Years. As far as it was consent from the individual study participant, the study data could be shared with other investigators within and outside of the EU for purposes of further studying SARS-CoV2 infection. To obtain data please contact the person responsible for the study (mladen.tzvetkov@med.uni-greifswald.de). The data will be available only in pseudonymized form. No contact or other personal data of the study participants will be available.

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Organizational Data

  •   DRKS00021672
  •   2020/12/01
  •   [---]*
  •   yes
  •   Approved
  •   BB 059/20, Ethikkommission an der Medizinischen Fakultät der Ernst-Moritz-Arndt-Universität Greifswald
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   COVID-19
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Interventions/Observational Groups

  •   Patients with positive SARS-CoV-2 infection are interviewed with a questionnaire about previous illnesses and the course of symptoms over 25 days after a positive test.
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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

The primary outcome is the course of SARS-CoV-2 infection classified according to the WHO ladder as follows:
score 1: Outpatient with mild course of infection; no limitation of patient activities;
score 2: Outpatient with mild course of infection but with limited activities, no hospital admission necessary;
score 3: Moderately course; hospitalized, no oxygen supply necessary;
score 4: Moderately course; hospitalized, oxygen supply via oxygen mask or nasal cannula,
score 5: Severe course; non-invasive ventilation or high-flow oxygen therapy;
score 6: Severe course; intubation and invasive ventilation,
score 7: Severe course; intubation and invasive ventilation + additional organ function support, renal replacement therapy, ECMO;
score 8: Death; patient's death;
The following parameters should be recorded in individuals who have tested positive for infection with the SARSCoV-2 virus
- General information on the participating persons such as gender and age, as well as information on lifestyle, e.g. smoking
- pre-existing conditions such as cardiovascular or oncological diseases, previous damage of the lung or liver, infections with other pathogens or colonization with multi-resistant pathogens and other pre-existing underlying diseases
- Information on medication already taken before the illness
- Information about the medication taken during the course of the disease, e.g. antipyretic preparations

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Secondary Outcome

As secondary endpoints are defined (i) descriptive analyses of the prevalence and duration of symptoms in outpatients and (ii) association analysis of the prevalence and duration of single symptoms with the risk and protective factors listed above.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/04/30
  •   400
  •   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

Individuals with a PCR-confirmed SARS-CoV-2 infection. This includes persons who have been examined in the test centers in Mecklenburg-Western Pomerania on an outpatient basis as well as inpatients admitted to Greifswald University Hospital or other participating hospitals.

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Exclusion Criteria

Below 18 years of age

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Addresses

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    • Universitätsmedizin Greifswald Körperschaft des öffentlichen Rechts
    • Fleischmannstraße 8
    • 17475  Greifswald
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Universitätsmedizin Greifswald Körperschaft des öffentlichen Rechts Institut für Pharmakologie
    • Mr.  Prof. Dr. rer. nat.  Mladen  Tzvetkov 
    • Felix-Hausdorff-Str. 3
    • 17487  Greifswald
    • Germany
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    • Universitätsmedizin Greifswald Körperschaft des öffentlichen Rechts Klinik für Anästhesiologie Anästhesie-, Intensiv-, Notfall- und Schmerzmedizin
    • Mr.  Prof. Dr. med.  Klaus  Hahnenkamp 
    • Ferdinand-Sauerbruch-Straße 1
    • 17475  Greifswald
    • Germany
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    • Institut für Community Medicine / Abt. Versorgungsepidemiologie und Community Health
    • Mr.  Prof. Dr. med.  Wolfgang  Hoffmann 
    • Ellernholzstr. 1-2
    • 17489  Greifswald
    • Germany
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    • Universitätsmedizin Greifswald Körperschaft des öffentlichen Rechts Institut für Pharmakologie
    • Mr.  Eik  Schäfer 
    • Felix-Hausdorff-Str. 3
    • 17487  Greifswald
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Greifswald Körperschaft des öffentlichen Rechts Institut für Pharmakologie
    • Mr.  Prof. Dr. rer. nat.  Mladen  Tzvetkov 
    • Felix-Hausdorff-Straße 3
    • 17487  Greifswald
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.