Trial document




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  DRKS00022495

Trial Description

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Title

Prospective validation of a proteomic urine test for early and accurate prognosis of critical course complications in patients with SARS-CoV-2 infection

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Trial Acronym

Crit-Cov-U

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The investigation of protein fragment patterns in urine (urine proteomics) is intended to predict the severity of Covid-19 disease.

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Brief Summary in Scientific Language

Three urine samples are collected from each patient or sent from home, a first urine sample at the time of the first presentation (day 0-1), a second on day 4-5 and a third on day 10-14, to determine the best time to collect the sample for prognostic purposes. A classification into moderate, severe and critical courses of disease is carried out according to the WHO classification criteria (to be found at: https://www.who.int/docs/default-source/coronaviruse/who-china-joint-mission-on-covid-19-final-report.pdf), which also includes intensive care, ventilation and death as patient-relevant endpoints.
The urine samples are collected, prepared, measured by CE-MS, evaluated and patient-specific peptide lists prepared according to established SOP specifications and in conformity with ISO standard 13485/2016. The peptide profiles of the first 250 patients at all sample times will be used to verify the 31 peptide markers associated with the severity of SARS-CoV-2 infection identified in the pilot study. The higher statistical power will also be used to search for additional peptide markers that show a correlation to the severity of SARS-CoV-2 infection. Based on the results of the statistical analysis, the COVID31 classification model established in a previous pilot study will be adapted. By classifying the first 250 patients at all sample times, the threshold value for a positive test result is determined with regard to the prediction of a critical course of disease in total cross-validation. The completion of the first phase of model optimization is documented before the model is then validated prospectively in routine operation on a further 750 patients using the predetermined threshold value for a positive test result. The final evaluation of the study will be performed using the established statistical methods Receiver Operating Characteristics and Precision Recall curves, as well as univariate and multivariate Cox regression analyses.

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

No

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Description IPD sharing plan:

N.a.

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Organizational Data

  •   DRKS00022495
  •   2020/08/25
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  •   yes
  •   Approved
  •   EK-BR-88/20-1, Ethikkommission bei der Sächsischen Landesärztekammer
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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

  •   Not applicable (observational study)
    Patients are screened for their urinary proteome and compared whether a proteome risk score is associated with the clinical severity of Covid-19 disease
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver
  •   Other
  •   Prognosis
  •   Factorial
  •   N/A
  •   N/A
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Primary Outcome

Predictive strength of a urine protein fragment pattern (proteomics) for the severity of Covid19 disease

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Secondary Outcome

Best time-point to use the urinary proteomic test for severity prediction of Covid-19 disease

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2020/08/01
  •   1000
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

Covid-19 disease
Ability for informed consent

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Exclusion Criteria

Anuria

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Addresses

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    • Medizinische Hochschule Hannover HannoverClinical Trial Center
    • Mr.  Prof. Dr. med.  Heiko  von der Leyen 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Klinik für Infektiologie, Nephrologie, Rheumatologie
    • Mr.  Prof. Dr. med.  Joachim  Beige 
    • Delitzscher Strasse 141 / Haus 54
    • 04129  Leipzig
    • Germany
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    • Medizinische Hochschule HannoverHannover Clinical Trial Center
    • Mr.  Prof. Dr.  Heiko  von der Leyen 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Gesundheit
    • Rochusstraße 1
    • 53123  Bonn
    • 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.