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

COVID-19 Clinical Trial

— COVID-19 NGS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04364828
• Other study ID #: COVID-19 NGS
• Status: Completed
• Phase: N/A
• Start date: October 21, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: November 2023
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: August 31, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• COVID-19 infection confirmed
• COVID-19 disease manifestation
• Age > 18 years

Exclusion Criteria:

• Missing informed consent of the patient/ legal guardian/ relatives

Related Conditions & MeSH terms

• COVID-19
• Disease Progression

Intervention

Genetic:
• Whole Genome Analysis
Whole Genome Analysis with whole transcriptome analysis and deoxyribonucleic acid (DNA) methylation analysis using Methylation beadchip (EPIC) arrays
• 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
• SARS-CoV-2 viral composition
Determined by Next Generation sequencing

Locations

Country	Name	City	State
Germany	University Hospital Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral evolution	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	Day 1, Day 3-5, Day 7-9, 48 hours after recovery
Secondary	Immune response	CD4+ and CD8+ T cells from blood (per µl) at different time points measured	Day 1, Day 3-5, Day 7-9, 48 hours after recovery
Secondary	Disease severity	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	Day 1, Day 3-5, Day 7-9, 48 hours after recovery