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Completed

NCT Number: NCT04364828

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

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 .

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Tübingen

Tübingen, 72076, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

whole genome analysis

Genetic

Whole Genome Analysis with whole transcriptome analysis and deoxyribonucleic acid (DNA) methylation analysis using Methylation beadchip (EPIC) arrays

T-cell receptor (TCR) repertoire

Genetic

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

Genetic

Determined by Next Generation sequencing

Primary outcomes

  1. 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

  1. Immune response

    Time frame: Day 1, Day 3-5, Day 7-9, 48 hours after recovery

    CD4+ and CD8+ T cells from blood (per µl) at different time points measured

  2. Disease severity

    Time frame: Day 1, Day 3-5, Day 7-9, 48 hours after recovery

    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

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Acronym: COVID-19 NGS

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 28, 2020
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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