In-depth Characterisation of the Dynamic Host Immune Response to Coronavirus SARS-CoV-2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Clinical Features
Study Overview
Brief Summary
The COntAGIouS trial (COvid-19 Advanced Genetic and Immunologic Sampling; an in-depth characterization of the dynamic host immune response to coronavirus SARS-CoV-2) proposes a transdisciplinary approach to identify host factors resulting in hyper-susceptibility to SARS-CoV-2 infection, which is urgently needed for directed medical interventions.
Detailed Description
The overall aim of this prospective study is to provide an in-depth characterization of clinical and immunological features of patients hospitalized in UZ Leuven because of SARS-CoV-2 infection. For this purpose, clinical data and blood, nasopharyngeal/rectal swab, and if safe, bronchoalveolar lavage (BAL) fluid and lung tissue samples will be collected from PCR- or CT-confirmed COVID-19 patients, with varying degrees of disease severity. Assessed characteristics will be compared between severe and non-severe COVID-19 patients, and between COVID-19 positive and negative ('control') patients.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients >/= 18 years old AND
- •Hospitalised with PCR-confirmed and/or CT-confirmed SARS-CoV-2 disease
Exclusion Criteria
- •Age < 18 years old
- •No informed consent
Outcomes
Primary Outcomes
Clinical Features
Time Frame: 6 months
Description of clinical, laboratory and radiological features of illness and complications.
Immune host response at systemic level
Time Frame: 6 months
Evaluation of dynamic host immune response at systemic level (immune signalling molecules in plasma, peripheral blood mononuclear cell isolation for advanced immunophenotyping and transcriptomics). Real-time analysis using CyTOF will be performed as screening, in combination with in-depth immunophenotyping.
Immune host response at local level
Time Frame: 6 months
Evaluation of dynamic host immune response at systemic level (immune signalling molecules in plasma, peripheral blood mononuclear cell isolation for advanced immunophenotyping and transcriptomics).
Host genetic variation
Time Frame: 6 months
Identification of host genetic variants that are associated with severity of disease.
Secondary Outcomes
- Correlation of immune profiling - microbiome(6 months)
- Comparison severe and non-severe COVID-19 hospitalised patients(6 months)
- Correlation of findings with outcome(6 months)