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Predictive performance and clinical application of COV50, a urinary proteomic biomarker in early COVID-19 infection : a prospective multicentre cohort study

Staessen, Jan A. (författare)
Non-Profit Research Institute Alliance for the Promotion of Preventive Medicine, Mechelen, Belgium; Biomedical Sciences Group, Faculty of Medicine, University of Leuven, Leuven, Belgium
Wendt, Ralph (författare)
Department of Infectious Diseases and Tropical Medicine, Nephrology and Kuratorium für Dialyse und Nierentransplantation Renal Unit and Rheumatology, St Georg Hospital, Leipzig, Germany
Yu, Yu-Ling (författare)
Research Unit Environment and Health, Department of Public Health and Primary Care, University of Leuven, Leuven, Belgium
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Kalbitz, Sven (författare)
Department of Infectious Diseases and Tropical Medicine, Nephrology and Kuratorium für Dialyse und Nierentransplantation Renal Unit and Rheumatology, St Georg Hospital, Leipzig, Germany
Thijs, Lutgarde (författare)
Research Unit Hypertension and Cardiovascular Epidemiology, Department of Cardiovascular Diseases, University of Leuven, Leuven, Belgium
Siwy, Justyna (författare)
Mosaiques-Diagnostics, Hannover, Germany
Raad, Julia (författare)
Mosaiques-Diagnostics, Hannover, Germany
Metzger, Jochen (författare)
Mosaiques-Diagnostics, Hannover, Germany
Neuhaus, Barbara (författare)
Centre for Clinical Trials, Medizinische Hochschule, Hannover, Germany
Papkalla, Armin (författare)
Centre for Clinical Trials, Medizinische Hochschule, Hannover, Germany
von der Leyen, Heiko (författare)
Centre for Clinical Trials, Medizinische Hochschule, Hannover, Germany
Mebazaa, Alexandre (författare)
Department of Anaesthesiology and Intensive Care, Hospital Saint Louis-Lariboisière, Paris, France
Dudoignon, Emmanuel (författare)
Department of Anaesthesiology and Intensive Care, Hospital Saint Louis-Lariboisière, Paris, France
Spasovski, Goce (författare)
Cyril and Methodius University, Skopje, North Macedonia
Milenkova, Mimoza (författare)
Cyril and Methodius University, Skopje, North Macedonia
Canevska-Taneska, Aleksandra (författare)
Cyril and Methodius University, Skopje, North Macedonia
Salgueira Lazo, Mercedes (författare)
Hospital Virgen Macarena, Sevilla, Spain
Psichogiou, Mina (författare)
First Department of Internal Medicine, Laiko General Hospital, National and Kapodistrian University of Athens Medical School, Athens, Greece
Rajzer, Marek W. (författare)
First Department of Cardiology, Interventional Electrocardiology and Arterial Hypertension, Jagiellonian University Medical College, Kraków, Poland
Fuławka, Łukasz (författare)
Molecular Pathology Centre Cellgen, Wrocław, Poland
Dzitkowska-Zabielska, Magdalena (författare)
Faculty of Physical Education, Gdańsk University of Physical Education and Sport and Centre of Translational Medicine, Medical University of Gdańsk, Gdańsk, Poland
Weiss, Guenter (författare)
Department of Internal Medicine II, Medical University Innsbruck, Innsbruck, Austria
Feldt, Torsten (författare)
Department of Gastroenterology, Hepatology and Infectious Diseases, Medical Faculty of Heinrich Heine University, Düsseldorf, Germany
Stegemann, Miriam (författare)
Department of Infectious Diseases and Respiratory Medicine, Charité Universitätsmedizin Berlin, Corporate Member of the Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
Normark, Johan (författare)
Umeå universitet,Institutionen för klinisk mikrobiologi,Wallenberg centrum för molekylär medicin vid Umeå universitet (WCMM)
Zoufaly, Alexander (författare)
Department of Medicine IV, Clinic Favoriten and Faculty of Medicine, Sigmund Freud University, Vienna, Austria
Schmiedel, Stefan (författare)
Medical Department I and Bernhard-Nocht-Clinic for Tropical Medicine, University Medical Centre Hamburg Eppendorf, Hamburg, Germany
Seilmaier, Michael (författare)
Department of Haematology, Oncology, Immunology, Palliative Care, Infectious Disease and Tropical Medicine, München Klinik Schwabing, München, Germany
Rumpf, Benedikt (författare)
Nephrology and Dialysis, Internal Medicine III, Medical University of Vienna, Vienna, Austria
Banasik, Mirosław (författare)
Department of Nephrology and Transplantation Medicine, Wrocław Medical University, Wrocław, Poland
Krajewska, Magdalena (författare)
Department of Nephrology and Transplantation Medicine, Wrocław Medical University, Wrocław, Poland
Catanese, Lorenzo (författare)
Department of Nephrology, Angiology and Rheumatology, Hospital Bayreuth, Bayreuth, Germany
Rupprecht, Harald D. (författare)
Department of Nephrology, Angiology and Rheumatology, Hospital Bayreuth, Bayreuth, Germany
Czerwieńska, Beata (författare)
University of Silesia, Katowice, Poland
Peters, Björn (författare)
Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine
Nilsson, Åsa (författare)
Research and Development Centre, Skaraborg Hospital, Skövde, Sweden
Rothfuss, Katja (författare)
Department of Gastroenterology, Hepatology and Endocrinology, Robert Bosch Hospital, Stuttgart, Germany
Lübbert, Christoph (författare)
Department of Infectious Diseases and Tropical Medicine, Nephrology and Kuratorium für Dialyse und Nierentransplantation Renal Unit and Rheumatology, St Georg Hospital, Leipzig, Germany; Division of Infectious Diseases and Tropical Medicine, Leipzig University Medical Centre, Leipzig, Germany
Mischak, Harald (författare)
Mosaiques-Diagnostics, Hannover, Germany; Institute of Cardiovascular and Medical Sciences, Glasgow, United Kingdom
Beige, Joachim (författare)
Department of Infectious Diseases and Tropical Medicine, Nephrology and Kuratorium für Dialyse und Nierentransplantation Renal Unit and Rheumatology, St Georg Hospital, Leipzig, Germany; Martin-Luther-University Halle-Wittenberg, Halle an der Saale, Halle, Germany
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 (creator_code:org_t)
Elsevier, 2022
2022
Engelska.
Ingår i: The Lancet Digital Health. - : Elsevier. - 2589-7500. ; 4:10, s. e727-e737
Relaterad länk:
https://doi.org/10.1...
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https://umu.diva-por... (primary) (Raw object)
https://urn.kb.se/re...
https://doi.org/10.1...
https://gup.ub.gu.se...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
Stäng  
  • Background: The SARS-CoV-2 pandemic is a worldwide challenge. The CRIT-CoV-U pilot study generated a urinary proteomic biomarker consisting of 50 peptides (COV50), which predicted death and disease progression from SARS-CoV-2. After the interim analysis presented for the German Government, here, we aimed to analyse the full dataset to consolidate the findings and propose potential clinical applications of this biomarker.Methods: CRIT-CoV-U was a prospective multicentre cohort study. In eight European countries (Austria, France, Germany, Greece, North Macedonia, Poland, Spain, and Sweden), 1012 adults with PCR-confirmed COVID-19 were followed up for death and progression along the 8-point WHO scale. Capillary electrophoresis coupled with mass spectrometry was used for urinary proteomic profiling. Statistical methods included logistic regression and receiver operating characteristic curve analysis with a comparison of the area under curve (AUC) between nested models. Hospitalisation costs were derived from the care facility corresponding with the Markov chain probability of reaching WHO scores ranging from 3 to 8 and flat-rate hospitalisation costs adjusted for the gross per capita domestic product of each country.Findings: From June 30 to Nov 19, 2020, 228 participants were recruited, and from April 30, 2020, to April 14, 2021, 784 participants were recruited, resulting in a total of 1012 participants. The entry WHO scores were 1–3 in 445 (44%) participants, 4–5 in 529 (52%) participants, and 6 in 38 (4%) participants; and of all participants, 119 died and 271 had disease progression. The odds ratio (OR) associated with COV50 in all 1012 participants for death was 2·44 (95% CI 2·05–2·92) unadjusted and 1·67 (1·34–2·07) when adjusted for sex, age, BMI, comorbidities, and baseline WHO score; and for disease progression, the OR was 1·79 (1·60–2·01) when unadjusted and 1·63 (1·41–1·91) when adjusted (p<0·0001 for all). The predictive accuracy of the optimised COV50 thresholds was 74·4% (71·6–77·1%) for mortality (threshold 0·47) and 67·4% (64·4–70·3%) for disease progression (threshold 0·04). When adjusted for covariables and the baseline WHO score, these thresholds improved AUCs from 0·835 to 0·853 (p=0·033) for death and from 0·697 to 0·730 (p=0·0008) for progression. Of 196 participants who received ambulatory care, 194 (99%) did not reach the 0·04 threshold. The cost reductions associated with 1 day less hospitalisation per 1000 participants were million Euro (M€) 0·887 (5–95% percentile interval 0·730–1·039) in participants at a low risk (COV50 <0·04) and M€2·098 (1·839-2·365) in participants at a high risk (COV50 ≥0·04).Interpretation: The urinary proteomic COV50 marker might be predictive of adverse COVID-19 outcomes. Even in people with mild-to-moderate PCR-confirmed infections (WHO scores 1–4), the 0·04 COV50 threshold justifies earlier drug treatment, thereby potentially reducing the number of days in hospital and associated costs. Funding: German Federal Ministry of Health.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Urologi och njurmedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Urology and Nephrology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Hälsovetenskap -- Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Health Sciences -- Public Health, Global Health, Social Medicine and Epidemiology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Infectious Medicine (hsv//eng)

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