Trials / Completed
CompletedNCT04364828
NGS Diagnostic in COVID-19 Hosts - Genetic Cause Relating to the Course of Disease Progression
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,000 (actual)
- Sponsor
- University Hospital Tuebingen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | Whole Genome Analysis | Whole Genome Analysis with whole transcriptome analysis and deoxyribonucleic acid (DNA) methylation analysis using Methylation beadchip (EPIC) arrays |
| 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 |
| GENETIC | SARS-CoV-2 viral composition | Determined by Next Generation sequencing |
Timeline
- Start date
- 2020-10-21
- Primary completion
- 2023-04-30
- Completion
- 2023-08-31
- First posted
- 2020-04-28
- Last updated
- 2023-11-29
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04364828. Inclusion in this directory is not an endorsement.