Studying the pathophysiology of coronavirus disease 2019: a protocol for the Berlin prospective COVID-19 patient cohort (Pa-COVID-19)

Florian Kurth^{1

2}, Maria Roennefarth³, Charlotte Thibeault⁴, Victor M Corman⁵, Holger Müller-Redetzky⁴, Mirja Mittermaier⁴, Christoph Ruwwe-Glösenkamp⁴, Katrin M Heim⁴, Alexander Krannich³, Saskia Zvorc³, Sein Schmidt³, Lucie Kretzler³, Chantip Dang-Heine³, Matthias Rose⁶, Michael Hummel⁷, Andreas Hocke⁴, Ralf H Hübner⁴, Bastian Opitz⁴, Marcus A Mall⁸, Jobst Röhmel⁸, Ulf Landmesser⁹, Burkert Pieske¹⁰, Samuel Knauss¹¹, Matthias Endres¹¹, Joachim Spranger¹², Frank P Mockenhaupt¹³, Frank Tacke¹⁴, Sascha Treskatsch¹⁵, Stefan Angermair¹⁶, Britta Siegmund¹⁶, Claudia Spies¹⁷, Steffen Weber-Carstens¹⁷, Kai-Uwe Eckardt¹⁸, Dirk Schürmann⁴, Alexander Uhrig⁴, Miriam S Stegemann⁴, Thomas Zoller⁴, Christian Drosten⁵, Norbert Suttorp⁴, Martin Witzenrath⁴, Stefan Hippenstiel⁴, Christof von Kalle¹⁹, Leif Erik Sander²⁰

Affiliations

¹ 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@charite.de.
² Department of Tropical Medicine, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany. florian.kurth@charite.de.
³ 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.
⁴ 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.
⁵ Institute of Virology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
⁶ Department of Psychosomatic Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
⁷ 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.
⁸ 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.
⁹ Department of Cardiology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
¹⁰ 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.
¹¹ 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.
¹² 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.
¹³ 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.
¹⁴ 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.
¹⁵ 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.
¹⁶ 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.
¹⁷ 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.
¹⁸ 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.
¹⁹ 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.
²⁰ 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. leif-erik.sander@charite.de.

PMID: 32535877
PMCID: PMC7293426
DOI: 10.1007/s15010-020-01464-x

Studying the pathophysiology of coronavirus disease 2019: a protocol for the Berlin prospective COVID-19 patient cohort (Pa-COVID-19)

Florian Kurth et al. Infection. 2020 Aug.

. 2020 Aug;48(4):619-626.

doi: 10.1007/s15010-020-01464-x. Epub 2020 Jun 13.

Authors

Affiliations

¹ 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@charite.de.
² Department of Tropical Medicine, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany. florian.kurth@charite.de.
³ 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.
⁴ 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.
⁵ Institute of Virology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
⁶ Department of Psychosomatic Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
⁷ 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.
⁸ 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.
⁹ Department of Cardiology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
¹⁰ 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.
¹¹ 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.
¹² 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.
¹³ 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.
¹⁴ 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.
¹⁵ 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.
¹⁶ 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.
¹⁷ 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.
¹⁸ 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.
¹⁹ 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.
²⁰ 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. leif-erik.sander@charite.de.

PMID: 32535877
PMCID: PMC7293426
DOI: 10.1007/s15010-020-01464-x

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).

Keywords: COVID-19; Clinical phenotyping; Coronavirus; Infectious disease; Patient registry; SARS-CoV-2.

PubMed Disclaimer

Conflict of interest statement

None of the authors have any conflicts of interest or competing interests to declare for this specific project.

Figures

**Fig. 1**
Depiction of serial bio-sampling and analysis performed during study conduction; pathogen testing will be performed only at first study visit (V1), while serial blood sampling will be performed repetitively at every study visit (V1–V13)

See this image and copyright information in PMC

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Studying the pathophysiology of coronavirus disease 2019: a protocol for the Berlin prospective COVID-19 patient cohort (Pa-COVID-19)

Affiliations

Studying the pathophysiology of coronavirus disease 2019: a protocol for the Berlin prospective COVID-19 patient cohort (Pa-COVID-19)

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources

Other Literature Sources

Miscellaneous