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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICU-hospitalised COVID-19 patients | COVID-19 positive patients hospitalised in intensive care ('severe disease'). |
| |
| ward-hospitalised COVID-19 patients | COVID-19 positive patients requiring hospitalisation,not on intensive care department ('non-severe'). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient sampling | Other | Blood draw, NP/rectal swab, bronchoscopy if clinically indicated, lung tissue if applicable |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients (>18 years old) that are admitted to UZ Leuven from March 2020 until September 2026 with PCR-confirmed and/or CT-confirmed SARS-CoV-2 disease are eligible for inclusion.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joost Wauters, MD PhD | Contact | 003216344275 | joost.wauters@uzleuven.com |
| Name | Affiliation | Role |
|---|---|---|
| Joost Wauters, MD PhD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41566340 | Derived | Virga F, Taverna D, Ferrero G, Leclercq M, El Hachem N, Godoy-Tena G, Jacobs C, Tarallo S, Pardini B, Naccarati A, Wauters J, Lauwers HM, Wauters E, Close P, Orso F, Mazzone M. Transcriptome changes in circulating immune cells of critical COVID-19 patients predict a specific metabolic and epigenetic imprint. J Transl Med. 2026 Jan 22;24(1):247. doi: 10.1186/s12967-025-07665-y. |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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Blood, plasma, PBMC, BAL, lung tissue
| 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 |
| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |