In-depth Immunological Investigation of COVID-19.

Study Overview
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Brief Summary
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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
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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.

Official Title
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In-depth Characterisation of the Dynamic Host Immune Response to Coronavirus SARS-CoV-2

Conditions
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Coronavirus Infections

Intervention / Treatment
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* Other: Patient sampling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICU-hospitalised COVID-19 patients<br>COVID-19 positive patients hospitalised in intensive care ('severe disease'). | Other: Patient sampling<br>* Blood draw, NP/rectal swab, bronchoscopy if clinically indicated, lung tissue if applicable<br>|
| ward-hospitalised COVID-19 patients<br>COVID-19 positive patients requiring hospitalisation,not on intensive care department ('non-severe'). | Other: Patient sampling<br>* Blood draw, NP/rectal swab, bronchoscopy if clinically indicated, lung tissue if applicable<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Features | Description of clinical, laboratory and radiological features of illness and complications. | 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. | 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). | 6 months | 
| Host genetic variation | Identification of host genetic variants that are associated with severity of disease. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison severe and non-severe COVID-19 hospitalised patients | Differences in baseline factors | 6 months | 
| Comparison severe and non-severe COVID-19 hospitalised patients | Differences in immune characteristics | 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 | 6 months | 
| Correlation of immune profiling - microbiome | Correlation of immune profiling with microbiome analysis of patients | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19