NGS Diagnostic in COVID-19 Hosts - Genetic Cause Relating to the Course of Disease Progression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,000
- Locations
- 2
- Primary Endpoint
- Viral evolution
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
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)