Official Title
NGS Diagnostic in COVID-19 Hosts - Genetic Cause Relating to the Course of Disease Progression
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).

Not yet recruiting
COVID-19

Genetic: Whole Genome Analysis
Whole Genome Analysis with whole transcriptome analysis and deoxyribonucleic acid (DNA) methylation analysis using Methylation beadchip (EPIC) arrays
Host Genome Analysis

Genetic: T-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
Host Response to SARS-CoV-2 Infection

Genetic: SARS-CoV-2 viral composition
Determined by Next Generation sequencing
Viral Sequence Composition

Eligibility Criteria

Inclusion Criteria: - COVID-19 infection confirmed - COVID-19 disease manifestation - Age > 18 years

Exclusion Criteria: - Missing informed consent of the patient/ legal guardian/ relatives

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Contacts

Olaf Rieß, Prof. Dr.
+49 (0)7071-29- 72288
olaf.riess@med.uni-tuebingen.de

Michael Bitzer, Prof. Dr.
+49 (0)7071-29- 80583
m.bitzer@med.uni-tuebingen.de

Olaf Rieß, Prof. Dr.
Study Director
University Hospital Tübingen

University Hospital Tuebingen
NCT Number
Keywords
Covid-19
SARS-CoV-2
Next-Generation-Sequencing
Whole Genome Analysis
MultiOmics
Extreme phenotypes
MeSH Terms
Disease Progression