Abstract
PurposeSevere 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.MethodsPa-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.ResultsOutcome 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.ConclusionWe 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 registrationRegistered at the German registry for clinical studies (DRKS00021688)
Highlights
Lower respiratory tract infections cause several millions of deaths every year and remain the most deadly communicable disease as reported by WHO (Global Health Observatory (GHO) data of the WHO, 2018)
Despite global spread by travelers [3, 4], MERS-CoV remains largely confined to the Arabian Peninsula
In December 2019, first cases of what was later identified as infections with a novel coronavirus, termed Severe Acute Respiratory Syndrome (SARS)-CoV-2, emerged in Wuhan, China [5]
Summary
Lower respiratory tract infections cause several millions of deaths every year and remain the most deadly communicable disease as reported by WHO (Global Health Observatory (GHO) data of the WHO, 2018). Comprehensive phenotyping of diseases caused by new infectious agents is. In the past 20 years alone, zoonotic viruses have caused multiple outbreaks, which all involved respiratory infections. In November 2003, Severe Acute Respiratory Syndrome (SARS) virus caused a global disease outbreak with > 8000 infections and 774 deaths [1]. In 2012, the first infection with a new Coronavirus, the Middle-East Respiratory Syndrome Coronavirus (MERSCoV), was recorded [2]. In December 2019, first cases of what was later identified as infections with a novel coronavirus, termed SARS-CoV-2, emerged in Wuhan, China [5]. According to WHO, by the middle of April, there are more than 2,000,000 confirmed infections with > 120,000 deaths worldwide
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
