COVID-19
Conditions
Keywords
COVID-19, SARS-CoV-2, Next-Generation-Sequencing, Whole Genome Analysis, MultiOmics, Extreme phenotypes
Brief summary
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 .
Detailed description
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).
Interventions
GENETICWhole Genome Analysis
Whole Genome Analysis with whole transcriptome analysis and deoxyribonucleic acid (DNA) methylation analysis using Methylation beadchip (EPIC) arrays
GENETICT-cell receptor (TCR) repertoire
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
GENETICSARS-CoV-2 viral composition
Determined by Next Generation sequencing
Sponsors
University Hospital Tuebingen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* COVID-19 infection confirmed * COVID-19 disease manifestation * Age \> 18 years
Exclusion criteria
* Missing informed consent of the patient/ legal guardian/ relatives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral evolution | Day 1, Day 3-5, Day 7-9, 48 hours after recovery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune response | Day 1, Day 3-5, Day 7-9, 48 hours after recovery | CD4+ and CD8+ T cells from blood (per µl) at different time points measured |
| Disease severity | Day 1, Day 3-5, Day 7-9, 48 hours after recovery | 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 |
Countries
Germany
Outcome results
None listed