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Studying the pathophysiology of coronavirus disease 2019: a protocol for the Berlin prospective COVID-19 patient cohort (Pa-COVID-19).
Kurth, Florian; Roennefarth, Maria; Thibeault, Charlotte; Corman, Victor M; Müller-Redetzky, Holger; Mittermaier, Mirja; Ruwwe-Glösenkamp, Christoph; Heim, Katrin M; Krannich, Alexander; Zvorc, Saskia; Schmidt, Sein; Kretzler, Lucie; Dang-Heine, Chantip; Rose, Matthias; Hummel, Michael; Hocke, Andreas; Hübner, Ralf H; Opitz, Bastian; Mall, Marcus A; Röhmel, Jobst; Landmesser, Ulf; Pieske, Burkert; Knauss, Samuel; Endres, Matthias; Spranger, Joachim; Mockenhaupt, Frank P; Tacke, Frank; Treskatsch, Sascha; Angermair, Stefan; Siegmund, Britta; Spies, Claudia; Weber-Carstens, Steffen; Eckardt, Kai-Uwe; Schürmann, Dirk; Uhrig, Alexander; Stegemann, Miriam S; Zoller, Thomas; Drosten, Christian; Suttorp, Norbert; Witzenrath, Martin; Hippenstiel, Stefan; von Kalle, Christof; Sander, Leif Erik.
  • Kurth F; Department of Infectious Diseases and Respiratory Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Campus Virchow Klinikum, Augustenburgerplatz 1, 13353, Berlin, Germany. florian.kurth@charit
  • Roennefarth M; Department of Tropical Medicine, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany. florian.kurth@charite.de.
  • Thibeault C; Clinical Study Center (CSC), Berlin Institute of Health, and Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, Campus Charité Mitte, Charitéplatz 1, 10117, Berlin, Germany.
  • Corman VM; Department of Infectious Diseases and Respiratory Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Campus Virchow Klinikum, Augustenburgerplatz 1, 13353, Berlin, Germany.
  • Müller-Redetzky H; Institute of Virology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Mittermaier M; Department of Infectious Diseases and Respiratory Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Campus Virchow Klinikum, Augustenburgerplatz 1, 13353, Berlin, Germany.
  • Ruwwe-Glösenkamp C; Department of Infectious Diseases and Respiratory Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Campus Virchow Klinikum, Augustenburgerplatz 1, 13353, Berlin, Germany.
  • Heim KM; Department of Infectious Diseases and Respiratory Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Campus Virchow Klinikum, Augustenburgerplatz 1, 13353, Berlin, Germany.
  • Krannich A; Department of Infectious Diseases and Respiratory Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Campus Virchow Klinikum, Augustenburgerplatz 1, 13353, Berlin, Germany.
  • Zvorc S; Clinical Study Center (CSC), Berlin Institute of Health, and Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, Campus Charité Mitte, Charitéplatz 1, 10117, Berlin, Germany.
  • Schmidt S; Clinical Study Center (CSC), Berlin Institute of Health, and Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, Campus Charité Mitte, Charitéplatz 1, 10117, Berlin, Germany.
  • Kretzler L; Clinical Study Center (CSC), Berlin Institute of Health, and Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, Campus Charité Mitte, Charitéplatz 1, 10117, Berlin, Germany.
  • Dang-Heine C; Clinical Study Center (CSC), Berlin Institute of Health, and Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, Campus Charité Mitte, Charitéplatz 1, 10117, Berlin, Germany.
  • Rose M; Clinical Study Center (CSC), Berlin Institute of Health, and Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, Campus Charité Mitte, Charitéplatz 1, 10117, Berlin, Germany.
  • Hummel M; Department of Psychosomatic Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Hocke A; Central Biobank Charité (ZeBanC), Institute of Pathology, Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Hübner RH; Department of Infectious Diseases and Respiratory Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Campus Virchow Klinikum, Augustenburgerplatz 1, 13353, Berlin, Germany.
  • Opitz B; Department of Infectious Diseases and Respiratory Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Campus Virchow Klinikum, Augustenburgerplatz 1, 13353, Berlin, Germany.
  • Mall MA; Department of Infectious Diseases and Respiratory Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Campus Virchow Klinikum, Augustenburgerplatz 1, 13353, Berlin, Germany.
  • Röhmel J; Department of Pediatric Pulmonology, Immunology and Critical Care Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Landmesser U; Department of Pediatric Pulmonology, Immunology and Critical Care Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Pieske B; Department of Cardiology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Knauss S; Medical Department, Division of Cardiology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Campus Virchow-Klinikum, Berlin, Germany.
  • Endres M; Department of Neurology with Experimental Neurology and Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Spranger J; Department of Neurology with Experimental Neurology and Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Mockenhaupt FP; Department of Endocrinology and Metabolism, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Tacke F; Institute of Tropical Medicine and International Health Berlin, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Treskatsch S; Department of Hepatology and Gastroenterology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Angermair S; Department of Anaesthesiology and Intensive Care Medicine, Charite Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Siegmund B; Division of Gastroenterology, Infectious Diseases, Rheumatology, Medical Department, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Spies C; Division of Gastroenterology, Infectious Diseases, Rheumatology, Medical Department, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Weber-Carstens S; Department of Anesthesiology and Operative Intensive Care Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Eckardt KU; Department of Anesthesiology and Operative Intensive Care Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Schürmann D; Department of Nephrology and Internal Intensive Care Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Uhrig A; Department of Infectious Diseases and Respiratory Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Campus Virchow Klinikum, Augustenburgerplatz 1, 13353, Berlin, Germany.
  • Stegemann MS; Department of Infectious Diseases and Respiratory Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Campus Virchow Klinikum, Augustenburgerplatz 1, 13353, Berlin, Germany.
  • Zoller T; Department of Infectious Diseases and Respiratory Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Campus Virchow Klinikum, Augustenburgerplatz 1, 13353, Berlin, Germany.
  • Drosten C; Department of Infectious Diseases and Respiratory Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Campus Virchow Klinikum, Augustenburgerplatz 1, 13353, Berlin, Germany.
  • Suttorp N; Institute of Virology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Witzenrath M; Department of Infectious Diseases and Respiratory Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Campus Virchow Klinikum, Augustenburgerplatz 1, 13353, Berlin, Germany.
  • Hippenstiel S; Department of Infectious Diseases and Respiratory Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Campus Virchow Klinikum, Augustenburgerplatz 1, 13353, Berlin, Germany.
  • von Kalle C; Department of Infectious Diseases and Respiratory Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Campus Virchow Klinikum, Augustenburgerplatz 1, 13353, Berlin, Germany.
  • Sander LE; Clinical Study Center (CSC), Berlin Institute of Health, and Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, Campus Charité Mitte, Charitéplatz 1, 10117, Berlin, Germany. christof.kalle@charite.de.
Infection ; 48(4): 619-626, 2020 Aug.
Article in English | MEDLINE | ID: covidwho-597401
ABSTRACT

PURPOSE:

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread worldwide causing a global health emergency. Pa-COVID-19 aims to provide comprehensive data on clinical course, pathophysiology, immunology and outcome of COVID-19, to identify prognostic biomarkers, clinical scores, and therapeutic targets for improved clinical management and preventive interventions.

METHODS:

Pa-COVID-19 is a prospective observational cohort study of patients with confirmed SARS-CoV-2 infection treated at Charité - Universitätsmedizin Berlin. We collect data on epidemiology, demography, medical history, symptoms, clinical course, and pathogen testing and treatment. Systematic, serial blood sampling will allow deep molecular and immunological phenotyping, transcriptomic profiling, and comprehensive biobanking. Longitudinal data and sample collection during hospitalization will be supplemented by long-term follow-up.

RESULTS:

Outcome measures include the WHO clinical ordinal scale on day 15 and clinical, functional, and health-related quality-of-life assessments at discharge and during follow-up. We developed a scalable dataset to (i) suit national standards of care, (ii) facilitate comprehensive data collection in medical care facilities with varying resources, and (iii) allow for rapid implementation of interventional trials based on the standardized study design and data collection. We propose this scalable protocol as blueprint for harmonized data collection and deep phenotyping in COVID-19 in Germany.

CONCLUSION:

We established a basic platform for harmonized, scalable data collection, pathophysiological analysis, and deep phenotyping of COVID-19, which enables rapid generation of evidence for improved medical care and identification of candidate therapeutic and preventive strategies. The electronic database accredited for interventional trials allows fast trial implementation for candidate therapeutic agents. TRIAL REGISTRATION Registered at the German registry for clinical studies (DRKS00021688).
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Registries / Coronavirus Infections Type of study: Cohort study / Observational study / Prognostic study / Randomized controlled trials / Systematic review/Meta Analysis Topics: Long Covid Limits: Humans Country/Region as subject: Europa Language: English Journal: Infection Year: 2020 Document Type: Article Affiliation country: S15010-020-01464-x

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Registries / Coronavirus Infections Type of study: Cohort study / Observational study / Prognostic study / Randomized controlled trials / Systematic review/Meta Analysis Topics: Long Covid Limits: Humans Country/Region as subject: Europa Language: English Journal: Infection Year: 2020 Document Type: Article Affiliation country: S15010-020-01464-x