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

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...

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Veröffentlicht in:Infection 2020-08, Vol.48 (4), p.619-626
Hauptverfasser: 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
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container_end_page 626
container_issue 4
container_start_page 619
container_title Infection
container_volume 48
creator 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
description 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)
doi_str_mv 10.1007/s15010-020-01464-x
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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. 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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)</description><subject>Berlin - epidemiology</subject><subject>Betacoronavirus</subject><subject>Biological Specimen Banks</subject><subject>Biomarkers</subject><subject>Chemical compounds</subject><subject>Clinical trials</subject><subject>Coronaviridae</subject><subject>Coronavirus Infections - epidemiology</subject><subject>Coronavirus Infections - physiopathology</subject><subject>Coronaviruses</subject><subject>COVID-19</subject><subject>Data collection</subject><subject>Demography</subject><subject>Depth profiling</subject><subject>Design standards</subject><subject>Disease Management</subject><subject>Epidemiology</subject><subject>Family Medicine</subject><subject>General Practice</subject><subject>Global health</subject><subject>Health care</subject><subject>Health services</subject><subject>Humans</subject><subject>Immunology</subject><subject>Infectious Diseases</subject><subject>Internal Medicine</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Observational studies</subject><subject>Observational Studies as Topic</subject><subject>Original Paper</subject><subject>Pandemics</subject><subject>Pathophysiology</subject><subject>Patients</subject><subject>Pharmacology</subject><subject>Phenotype</subject><subject>Phenotyping</subject><subject>Pneumonia, Viral - epidemiology</subject><subject>Pneumonia, Viral - physiopathology</subject><subject>Prospective Studies</subject><subject>Quality assessment</subject><subject>Registries</subject><subject>Risk Assessment</subject><subject>Risk Factors</subject><subject>SARS-CoV-2</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><subject>Signs and symptoms</subject><subject>Therapeutic applications</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Viral diseases</subject><subject>World Health Organization</subject><issn>0300-8126</issn><issn>1439-0973</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9kctq3DAUhkVpaSbTvkAXRdBNunB7JNmW3UWhnd4CgRR62QpZOh4reCxHsofMA-S9q8kk6WVRgRDo_8-nc_QT8ozBKwYgX0dWAIMMeNosL_Ps6gFZsFzUGdRSPCQLEABZxXh5RI5jvACAos7lY3IkeCGKSsoFuf42zXbnhjWdOqSjnjo_drvofO_XO-pbanzwg966MEdqXUQdkXJg9Ruq6Rj85I3vaevDTf17DL0b9vdxRDO5LdLV-c_TDxmr92yHw5SAnQ8TPfmqszvt5RPyqNV9xKe355L8-PTx--pLdnb--XT17iwzBfApM7kWYGtbSoQGyspCC1wy2WpT2tby3ACTtS0QOWCrm6bQzBbciKrlTGIjluTtgTvOzQatSf0E3asxuI0OO-W1U38rg-vU2m-V5LXIeZkAJ7eA4C9njJPauGiw7_WAfo6K5ywHYCKtJXnxj_XCz2FI4yXXHldVKasl4QeXSX8WA7b3zTBQ-5TVIWWVUlY3KaurVPT8zzHuS-5iTQZxMMQkDWsMv9_-D_YXtS6z0A</recordid><startdate>20200801</startdate><enddate>20200801</enddate><creator>Kurth, Florian</creator><creator>Roennefarth, Maria</creator><creator>Thibeault, Charlotte</creator><creator>Corman, Victor M.</creator><creator>Müller-Redetzky, Holger</creator><creator>Mittermaier, Mirja</creator><creator>Ruwwe-Glösenkamp, Christoph</creator><creator>Heim, Katrin M.</creator><creator>Krannich, Alexander</creator><creator>Zvorc, Saskia</creator><creator>Schmidt, Sein</creator><creator>Kretzler, Lucie</creator><creator>Dang-Heine, Chantip</creator><creator>Rose, Matthias</creator><creator>Hummel, Michael</creator><creator>Hocke, Andreas</creator><creator>Hübner, Ralf H.</creator><creator>Opitz, Bastian</creator><creator>Mall, Marcus A.</creator><creator>Röhmel, Jobst</creator><creator>Landmesser, Ulf</creator><creator>Pieske, Burkert</creator><creator>Knauss, Samuel</creator><creator>Endres, Matthias</creator><creator>Spranger, Joachim</creator><creator>Mockenhaupt, Frank P.</creator><creator>Tacke, Frank</creator><creator>Treskatsch, Sascha</creator><creator>Angermair, Stefan</creator><creator>Siegmund, Britta</creator><creator>Spies, Claudia</creator><creator>Weber-Carstens, Steffen</creator><creator>Eckardt, Kai-Uwe</creator><creator>Schürmann, Dirk</creator><creator>Uhrig, Alexander</creator><creator>Stegemann, Miriam S.</creator><creator>Zoller, Thomas</creator><creator>Drosten, Christian</creator><creator>Suttorp, Norbert</creator><creator>Witzenrath, Martin</creator><creator>Hippenstiel, Stefan</creator><creator>von Kalle, Christof</creator><creator>Sander, Leif Erik</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QL</scope><scope>7RV</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-3807-473X</orcidid></search><sort><creationdate>20200801</creationdate><title>Studying the pathophysiology of coronavirus disease 2019: a protocol for the Berlin prospective COVID-19 patient cohort (Pa-COVID-19)</title><author>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</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c502t-c4a30d9d67e0b068d0f02717fac6dfd24c0179d5ee20efabb5a1d52c38f217eb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Berlin - epidemiology</topic><topic>Betacoronavirus</topic><topic>Biological Specimen Banks</topic><topic>Biomarkers</topic><topic>Chemical compounds</topic><topic>Clinical trials</topic><topic>Coronaviridae</topic><topic>Coronavirus Infections - epidemiology</topic><topic>Coronavirus Infections - physiopathology</topic><topic>Coronaviruses</topic><topic>COVID-19</topic><topic>Data collection</topic><topic>Demography</topic><topic>Depth profiling</topic><topic>Design standards</topic><topic>Disease Management</topic><topic>Epidemiology</topic><topic>Family Medicine</topic><topic>General Practice</topic><topic>Global health</topic><topic>Health care</topic><topic>Health services</topic><topic>Humans</topic><topic>Immunology</topic><topic>Infectious Diseases</topic><topic>Internal Medicine</topic><topic>Medicine</topic><topic>Medicine &amp; 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Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Infection</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kurth, Florian</au><au>Roennefarth, Maria</au><au>Thibeault, Charlotte</au><au>Corman, Victor M.</au><au>Müller-Redetzky, Holger</au><au>Mittermaier, Mirja</au><au>Ruwwe-Glösenkamp, Christoph</au><au>Heim, Katrin M.</au><au>Krannich, Alexander</au><au>Zvorc, Saskia</au><au>Schmidt, Sein</au><au>Kretzler, Lucie</au><au>Dang-Heine, Chantip</au><au>Rose, Matthias</au><au>Hummel, Michael</au><au>Hocke, Andreas</au><au>Hübner, Ralf H.</au><au>Opitz, Bastian</au><au>Mall, Marcus A.</au><au>Röhmel, Jobst</au><au>Landmesser, Ulf</au><au>Pieske, Burkert</au><au>Knauss, Samuel</au><au>Endres, Matthias</au><au>Spranger, Joachim</au><au>Mockenhaupt, Frank P.</au><au>Tacke, Frank</au><au>Treskatsch, Sascha</au><au>Angermair, Stefan</au><au>Siegmund, Britta</au><au>Spies, Claudia</au><au>Weber-Carstens, Steffen</au><au>Eckardt, Kai-Uwe</au><au>Schürmann, Dirk</au><au>Uhrig, Alexander</au><au>Stegemann, Miriam S.</au><au>Zoller, Thomas</au><au>Drosten, Christian</au><au>Suttorp, Norbert</au><au>Witzenrath, Martin</au><au>Hippenstiel, Stefan</au><au>von Kalle, Christof</au><au>Sander, Leif Erik</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Studying the pathophysiology of coronavirus disease 2019: a protocol for the Berlin prospective COVID-19 patient cohort (Pa-COVID-19)</atitle><jtitle>Infection</jtitle><stitle>Infection</stitle><addtitle>Infection</addtitle><date>2020-08-01</date><risdate>2020</risdate><volume>48</volume><issue>4</issue><spage>619</spage><epage>626</epage><pages>619-626</pages><issn>0300-8126</issn><eissn>1439-0973</eissn><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)</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>32535877</pmid><doi>10.1007/s15010-020-01464-x</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-3807-473X</orcidid><oa>free_for_read</oa></addata></record>
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source MEDLINE; SpringerLink Journals - AutoHoldings
subjects Berlin - epidemiology
Betacoronavirus
Biological Specimen Banks
Biomarkers
Chemical compounds
Clinical trials
Coronaviridae
Coronavirus Infections - epidemiology
Coronavirus Infections - physiopathology
Coronaviruses
COVID-19
Data collection
Demography
Depth profiling
Design standards
Disease Management
Epidemiology
Family Medicine
General Practice
Global health
Health care
Health services
Humans
Immunology
Infectious Diseases
Internal Medicine
Medicine
Medicine & Public Health
Observational studies
Observational Studies as Topic
Original Paper
Pandemics
Pathophysiology
Patients
Pharmacology
Phenotype
Phenotyping
Pneumonia, Viral - epidemiology
Pneumonia, Viral - physiopathology
Prospective Studies
Quality assessment
Registries
Risk Assessment
Risk Factors
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
Signs and symptoms
Therapeutic applications
Time Factors
Treatment Outcome
Viral diseases
World Health Organization
title Studying the pathophysiology of coronavirus disease 2019: a protocol for the Berlin prospective COVID-19 patient cohort (Pa-COVID-19)
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