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Clinical trial

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

ID
Name
COVID-19 NGS
Description
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 .
Trial arms
Trial start
2020-10-21
Estimated PCD
2023-04-30
Trial end
2023-08-31
Status
Completed
Treatment
Whole Genome Analysis
Whole Genome Analysis with whole transcriptome analysis and deoxyribonucleic acid (DNA) methylation analysis using Methylation beadchip (EPIC) arrays
Arms:
Host Genome Analysis
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
Arms:
Host Response to SARS-CoV-2 Infection
SARS-CoV-2 viral composition
Determined by Next Generation sequencing
Arms:
Viral Sequence Composition
Size
1000
Primary endpoint
Viral evolution
Day 1, Day 3-5, Day 7-9, 48 hours after recovery
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1000, 'type': 'ACTUAL'}}
Updated at
2023-11-29

1 organization

3 products

1 indication

Organization
University Hospital Tübingen
Product
Whole Genome Analysis
Indication
COVID-19
Product
T-cell receptor (TCR) repertoire
Product
SARS-CoV-2