Studying the pathophysiology of coronavirus disease 2019: a protocol for the Berlin prospective COVID-19 patient cohort (Pa-COVID-19)
Top Cited Papers
Open Access
- 13 June 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in Infection
- Vol. 48 (4), 619-626
- https://doi.org/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
This publication has 26 references indexed in Scilit:
- Evidence for Camel-to-Human Transmission of MERS CoronavirusThe New England Journal of Medicine, 2014
- Transmission of MERS-Coronavirus in Household ContactsThe New England Journal of Medicine, 2014
- Patient-Reported Outcomes Measurement Information System (PROMIS): Efficient, standardized tools to measure self-reported health and quality of lifeNursing Outlook, 2014
- Open source clinical science for emerging infectionsThe Lancet Infectious Diseases, 2014
- Emerging Human Middle East Respiratory Syndrome Coronavirus Causes Widespread Infection and Alveolar Damage in Human LungsAmerican Journal of Respiratory and Critical Care Medicine, 2013
- Isolation of a Novel Coronavirus from a Man with Pneumonia in Saudi ArabiaThe New England Journal of Medicine, 2012
- Acute Respiratory Distress SyndromeJAMA, 2012
- Severe acute respiratory syndromeNature Medicine, 2004
- CAPNETZ?Community-Acquired Pneumonia Competence NetworkInfection, 2004
- Identification of a Novel Coronavirus in Patients with Severe Acute Respiratory SyndromeThe New England Journal of Medicine, 2003