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Open Access 01-08-2020 | Coronavirus | Original Paper

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

Authors: Florian Kurth, Maria Roennefarth, Charlotte Thibeault, Victor M. Corman, Holger Müller-Redetzky, Mirja Mittermaier, Christoph Ruwwe-Glösenkamp, Katrin M. Heim, Alexander Krannich, Saskia Zvorc, Sein Schmidt, Lucie Kretzler, Chantip Dang-Heine, Matthias Rose, Michael Hummel, Andreas Hocke, Ralf H. Hübner, Bastian Opitz, Marcus A. Mall, Jobst Röhmel, Ulf Landmesser, Burkert Pieske, Samuel Knauss, Matthias Endres, Joachim Spranger, Frank P. Mockenhaupt, Frank Tacke, Sascha Treskatsch, Stefan Angermair, Britta Siegmund, Claudia Spies, Steffen Weber-Carstens, Kai-Uwe Eckardt, Dirk Schürmann, Alexander Uhrig, Miriam S. Stegemann, Thomas Zoller, Christian Drosten, Norbert Suttorp, Martin Witzenrath, Stefan Hippenstiel, Christof von Kalle, Leif Erik Sander

Published in: Infection | Issue 4/2020

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)

Available only for authorised users

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Title: Studying the pathophysiology of coronavirus disease 2019: a protocol for the Berlin prospective COVID-19 patient cohort (Pa-COVID-19)
Authors: Florian Kurth
Maria Roennefarth
Charlotte Thibeault
Victor M. Corman
Holger Müller-Redetzky
Mirja Mittermaier
Christoph Ruwwe-Glösenkamp
Katrin M. Heim
Alexander Krannich
Saskia Zvorc
Sein Schmidt
Lucie Kretzler
Chantip Dang-Heine
Matthias Rose
Michael Hummel
Andreas Hocke
Ralf H. Hübner
Bastian Opitz
Marcus A. Mall
Jobst Röhmel
Ulf Landmesser
Burkert Pieske
Samuel Knauss
Matthias Endres
Joachim Spranger
Frank P. Mockenhaupt
Frank Tacke
Sascha Treskatsch
Stefan Angermair
Britta Siegmund
Claudia Spies
Steffen Weber-Carstens
Kai-Uwe Eckardt
Dirk Schürmann
Alexander Uhrig
Miriam S. Stegemann
Thomas Zoller
Christian Drosten
Norbert Suttorp
Martin Witzenrath
Stefan Hippenstiel
Christof von Kalle
Leif Erik Sander
Publication date: 01-08-2020
Publisher: Springer Berlin Heidelberg
Keywords: Coronavirus
SARS-CoV-2
COVID-19
Published in: Infection / Issue 4/2020
Print ISSN: 0300-8126
Electronic ISSN: 1439-0973
DOI: https://doi.org/10.1007/s15010-020-01464-x

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Abstract

Purpose

Methods

Results

Conclusion

Trial registration

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