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, in order 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, 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.
Competing Interest Statement
The authors have declared no competing interest.
Clinical Trial
The study is currently being registered in the German clinical trials register and the WHO International Clinical Trials Registry Platform (ID: DRKS00021688).
Funding Statement
not applicable
Author Declarations
All relevant ethical guidelines have been followed; any necessary IRB and/or ethics committee approvals have been obtained and details of the IRB/oversight body are included in the manuscript.
Yes
All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.
Yes
Footnotes
Trial Registration: registration for clinicaltrials.gov ongoing
Acknowledgements: This study is supported by the Clinical Study Center of Berlin Institute of Health, Charité - Universitätsmedizin Berlin, the Berlin Institute of Health and the Berlin University Alliance.
Declarations
Funding: not applicable.
Conflicts of interest/Competing interests:
None of the authors have any conflicts of interest or competing interests to declare for this specific project
Availability of data and material: the study protocol shall serve as a blueprint for studies conducted on patients infected with SARS-CoV-2 in Germany.
Code availability: the codebook of the digital case report form will be provided for observational studies with patients infected with SARS-CoV-2 nationwide on request
Data Availability
the study protocol shall serve as a blueprint for studies conducted on patients infected with SARS-CoV-2 in Germany.
