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.
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 Type
OBSERVATIONAL
Enrollment
100
Blood draw, NP/rectal swab, bronchoscopy if clinically indicated, lung tissue if applicable
UZ Leuven
Leuven, Belgium
RECRUITINGClinical Features
Description of clinical, laboratory and radiological features of illness and complications.
Time frame: 6 months
Immune host response at systemic level
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.
Time frame: 6 months
Immune host response at local level
Evaluation of dynamic host immune response at systemic level (immune signalling molecules in plasma, peripheral blood mononuclear cell isolation for advanced immunophenotyping and transcriptomics).
Time frame: 6 months
Host genetic variation
Identification of host genetic variants that are associated with severity of disease.
Time frame: 6 months
Comparison severe and non-severe COVID-19 hospitalised patients
Differences in baseline factors
Time frame: 6 months
Comparison severe and non-severe COVID-19 hospitalised patients
Differences in immune characteristics
Time frame: 6 months
Correlation of findings with outcome
Correlation of findings with outcome, aiming to identify early biomarkers of severe disease and putative targets for immunomodulatory therapy
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Time frame: 6 months
Correlation of immune profiling - microbiome
Correlation of immune profiling with microbiome analysis of patients
Time frame: 6 months