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

Not Applicable

Completed

• Conditions: COVID-19

• Registration Number: NCT04364828
• Lead Sponsor: University Hospital Tuebingen

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 Timeline

• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-24
• Study First Posted: 2020-04-28
• Study Start: 2020-10-21
• Primary Completion: 2023-04-30
• Study Completion: 2023-08-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Viral evolution	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 Outcome Measures

Name	Time	Method
Immune response	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
Disease severity	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

Trial Locations

Locations (1)

University Hospital Tübingen; 🇩🇪 Tübingen, Germany