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In-depth Immunological Investigation of COVID-19.

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04327570
Acronym
COntAGIouS
Enrollment
100
Registered
2020-03-31
Start date
2020-03-27
Completion date
2028-03-30
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Infections

Keywords

COVID-19

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.

Interventions

OTHERPatient sampling

Blood draw, NP/rectal swab, bronchoscopy if clinically indicated, lung tissue if applicable

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Clinical Features6 monthsDescription of clinical, laboratory and radiological features of illness and complications.
Immune host response at systemic level6 monthsEvaluation 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 level6 monthsEvaluation 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 variation6 monthsIdentification of host genetic variants that are associated with severity of disease.

Secondary

MeasureTime frameDescription
Comparison severe and non-severe COVID-19 hospitalised patients6 monthsDifferences in baseline factors
Correlation of findings with outcome6 monthsCorrelation of findings with outcome, aiming to identify early biomarkers of severe disease and putative targets for immunomodulatory therapy
Correlation of immune profiling - microbiome6 monthsCorrelation of immune profiling with microbiome analysis of patients

Countries

Belgium

Contacts

CONTACTJoost Wauters, MD PhD
joost.wauters@uzleuven.com003216344275
PRINCIPAL_INVESTIGATORJoost Wauters, MD PhD

UZ Leuven

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026