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Recruiting NCT04327570

In-depth Immunological Investigation of COVID-19.

Observational Coronavirus Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patient sampling.
Who it may be relevant to
Registry conditions: Coronavirus Infections. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other Patient sampling
    Blood draw, NP/rectal swab, bronchoscopy if clinically indicated, lung tissue if applicable

Primary outcome measures

  • Clinical Features [Time frame: 6 months]
  • Immune host response at systemic level [Time frame: 6 months]
  • Immune host response at local level [Time frame: 6 months]
  • Host genetic variation [Time frame: 6 months]
Secondary outcome measures (4)
  • Comparison severe and non-severe COVID-19 hospitalised patients [Time frame: 6 months]
  • Comparison severe and non-severe COVID-19 hospitalised patients [Time frame: 6 months]
  • Correlation of findings with outcome [Time frame: 6 months]
  • Correlation of immune profiling - microbiome [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Belgium · 1 center
  • UZ Leuven — Leuven

Publications

  • 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. PMID 41566340

Identifiers

NCT: NCT04327570 · COntAGIouS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗