In this study (i) the host genome to identify susceptibility regions of infection, inflammation, and host defense, (ii) host response to Severe Acute Respiratory Syndrome-Corona-Virus-2 (SARS-CoV-2) infection, and (iii) viral sequence composition to define viral sequences which may be correlated with disease severity in addition to the metagenome of the throat swab will be analysed .
This study aims to recruit adult persons with diagnostically confirmed Corona-Virus- Disease-19 (COVID-19) infection and with different disease manifestation who are included into diagnostic or therapeutic care at the University Hospital Tübingen (UKT). The COVID-19 Next-Generation-Sequencing (NGS) study aims to cover as many patients in Germany as possible. It is expected to include in Phase 1 (pilot study): 250 patients with different disease manifestation (extreme phenotypes) and individual risk factors by whole genome analysis Phase 2 (verification study): 1.000 clinically well-defined patients to ensure a broader range of overlapping phenotypes, to verify data from the pilot study. Phase 3 (confirmation study): \> 10.000 patients to increase the power (anticipated).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,000
Whole Genome Analysis with whole transcriptome analysis and deoxyribonucleic acid (DNA) methylation analysis using Methylation beadchip (EPIC) arrays
Longitudinal analysis of TCR repertoire of Cluster of Differentiation 4+ (CD4+) and CD8+ T cells from blood samples (Peripheral Blood Mononuclear Cells, PBMCs) from clinically characterized patients
Determined by Next Generation sequencing
University Hospital Tübingen
Tübingen, Germany
Viral evolution
The change in the genetic makeup of a virus population (measured in numbers) as the viruses mutate and multiply over time at different time points
Time frame: Day 1, Day 3-5, Day 7-9, 48 hours after recovery
Immune response
CD4+ and CD8+ T cells from blood (per µl) at different time points measured
Time frame: Day 1, Day 3-5, Day 7-9, 48 hours after recovery
Disease severity
Clinical classification according to severity: * Light and uncomplicated (mild symptoms) * Moderate (mild pneumonia) * Severe pneumonia * Critical (Acute Respiratory Distress Syndrome (ARDS), sepsis, septic shock) Evaluated at several time points
Time frame: Day 1, Day 3-5, Day 7-9, 48 hours after recovery
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