Trial document
DRKS00022495
Trial Description
Title
Prospective validation of a proteomic urine test for early and accurate prognosis of critical course complications in patients with SARS-CoV-2 infection
Trial Acronym
Crit-Cov-U
URL of the Trial
[---]*
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.
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.
Do you plan to share individual participant data with other researchers?
No
Description IPD sharing plan:
N.a.
Organizational Data
- DRKS00022495
- 2020/08/25
- [---]*
- yes
- Approved
- EK-BR-88/20-1, Ethikkommission bei der Sächsischen Landesärztekammer
Secondary IDs
- [---]*
Health Condition or Problem studied
- U07.1 - Emergency use of U07.1
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
Characteristics
- Non-interventional
- Observational study
- Other
- Blinded
- patient/subject, investigator/therapist, caregiver
- Other
- Prognosis
- Factorial
- N/A
- N/A
Primary Outcome
Predictive strength of a urine protein fragment pattern (proteomics) for the severity of Covid19 disease
Secondary Outcome
Best time-point to use the urinary proteomic test for severity prediction of Covid-19 disease
Countries of Recruitment
- Germany
- Austria
Locations of Recruitment
- Medical Center
Recruitment
- Actual
- 2020/08/01
- 1000
- Multicenter trial
- International
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
Covid-19 disease
Ability for informed consent
Exclusion Criteria
Anuria
Addresses
-
start of 1:1-Block address primary-sponsor
- Medizinische Hochschule Hannover HannoverClinical Trial Center
- Mr. Prof. Dr. med. Heiko von der Leyen
- Carl-Neuberg-Str. 1
- 30625 Hannover
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +49 511 532 115-10
- [---]*
- vonderLeyen.Heiko at mh-hannover.de
- http://www.mh-hannover.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Klinik für Infektiologie, Nephrologie, Rheumatologie
- Mr. Prof. Dr. med. Joachim Beige
- Delitzscher Strasse 141 / Haus 54
- 04129 Leipzig
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0341/9092613
- [---]*
- Joachim.Beige at kfh-dialyse.de
- http://www.sanktgeorg.de/nephro.html
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Medizinische Hochschule HannoverHannover Clinical Trial Center
- Mr. Prof. Dr. Heiko von der Leyen
- Carl-Neuberg-Str. 1
- 30625 Hannover
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 (0) 511 532 115-10
- [---]*
- vonderLeyen.Heiko at mh-hannover.de
- http://www.mh-hannover.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Bundesministerium für Gesundheit
- Rochusstraße 1
- 53123 Bonn
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- 030 18441-0
- [---]*
- poststelle at bmg.bund.de
- [---]*
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
- [---]*
Trial Publications, Results and other Documents
- [---]*