NGS Diagnostic in COVID-19 Hosts - Genetic Cause Relating to the Course of Disease Progression
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- University Hospital Tuebingen
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Viral evolution
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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).
Investigators
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
Outcomes
Primary Outcomes
Viral evolution
Time Frame: 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 Outcomes
- Immune response(Day 1, Day 3-5, Day 7-9, 48 hours after recovery)
- Disease severity(Day 1, Day 3-5, Day 7-9, 48 hours after recovery)