Trial document




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  DRKS00021591

Trial Description

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Title

Identification of predictive biomarkers for severe progression of COVID-19

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

In this study, we aim to identify biomarkers in a cohort of hospitalized immunocompetent patients which can predict the severity of a SARS-CoV-2 infection.

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

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00021591
  •   2020/04/27
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  •   yes
  •   Approved
  •   Eth-10/20, Ethik-Kommission der Ärztekammer Berlin
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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

  •   Serum is taken from hospitalized patients with COVID-19 at the following time points: within 24 hours of hospital admission, as well as on days 7, 10, 14, and 21 after onset of symptoms of COVID-19. In these samples, the following cytokines/chemokines are measured by ELISA: IL-1 alpha, IL-1 beta, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, TGF-beta1, TNF-alpha, Interferon-alpha, Interferon-beta, Interferon-gamma, TIMP-1, MMP-9, bFGF, CTGF, CXCL2, CCL2, CCL5, CXCL5. Additionally, SARS-CoV-2 antibodies are measured.
    Furthermore, the following vital signs are recorded on these time points: O2-saturation, blood pressure, heart rate, respiratory rate, and (on ventilated patients) parameters of mechanical ventilation.
    Bronchial fluids will be collected for measurement of these cytokines/chemokines from patients who need to undergo bronchoscopy for medical reasons.
    Patients who are discharged from hospital before reaching some of these time points will not be measured as outpatients: the respective time points will be omitted (the same applies for patients who present to hospital later than day 7 within onset of symptoms).
    After 30 days from onset of symptoms, the need for invasive or non-invasive ventilation will be recorded.
    After 1 year from onset of symptoms, the patient's family will be contacted and possible death will be recorded.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Invasive or non-invasive ventilation within 30 days of onset of COVID-19 related symptoms

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Secondary Outcome

Death of all causes within 1 year after onset of COVID-19 related symptoms

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2020/04/29
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Hospitalized patient due to clinical suspicion of COVID-19

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Exclusion Criteria

Patients under 18 years of age, immunosuppression, 2 x negative SARS-CoV-2 PCR during clinical course AND no typical signs of COVID-19 on chest CT

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Addresses

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    • Bundeswehrkrankenhaus Berlin, Klinik I (Innere Medizin)
    • Mr.  Dr. med.  Maximilian  Schreiner 
    • Scharnhorststraße 13
    • 10115  Berlin
    • Germany
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    • Bundeswehrkrankenhaus Berlin, Klinik I (Innere Medizin)
    • Mr.  Dr. med.  Maximilian  Schreiner 
    • Scharnhorstraße 13
    • 10115  Berlin
    • Germany
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    • Bundeswehrkrankenhaus Berlin, Klinik I (Innere Medizin)
    • Mr.  Christian  Zobel 
    • Scharnhorststraße 13
    • 10115  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Sanitätsakademie der Bundeswehr, Direktor Wehrmedizinische Wissenschaft und Fähigkeitsentwicklung Sanitätsdienst
    • Ingolstädter Straße 240
    • 80939  München
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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