COntAGIouS: In-depth Immunological Investigation of COVID-19.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ICU-hospitalised COVID-19 patients COVID-19 positive patients hospitalised in intensive care ('severe disease'). |
Other: Patient sampling
Blood draw, NP/rectal swab, bronchoscopy if clinically indicated, lung tissue if applicable
|
| ward-hospitalised COVID-19 patients COVID-19 positive patients requiring hospitalisation,not on intensive care department ('non-severe'). |
Other: Patient sampling
Blood draw, NP/rectal swab, bronchoscopy if clinically indicated, lung tissue if applicable
|
Outcome Measures
Primary Outcome Measures
- Clinical Features [6 months]
Description of clinical, laboratory and radiological features of illness and complications.
- Immune host response at systemic level [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 [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 [6 months]
Identification of host genetic variants that are associated with severity of disease.
Secondary Outcome Measures
- Comparison severe and non-severe COVID-19 hospitalised patients [6 months]
Differences in baseline factors
- Comparison severe and non-severe COVID-19 hospitalised patients [6 months]
Differences in immune characteristics
- Correlation of findings with outcome [6 months]
Correlation of findings with outcome, aiming to identify early biomarkers of severe disease and putative targets for immunomodulatory therapy
- Correlation of immune profiling - microbiome [6 months]
Correlation of immune profiling with microbiome analysis of patients
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients >/= 18 years old AND
-
Hospitalised with PCR-confirmed and/or CT-confirmed SARS-CoV-2 disease
Exclusion Criteria:
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Age < 18 years old
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No informed consent
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Patients on cyclosporine/tacrolimus/sirolimus/everolimus therapy*
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UZ Leuven | Leuven | Belgium | 3000 |
Sponsors and Collaborators
- Universitaire Ziekenhuizen Leuven
Investigators
- Principal Investigator: Joost Wauters, MD PhD, UZ Leuven
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COntAGIouS