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NCT Number: NCT04327570

In-depth Immunological Investigation of COVID-19.

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.

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Key information

Conditions

Coronavirus Infections COVID-19 Coronaviridae Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, 3000, Belgium

Location status: Recruiting

Location contact

Joost Wauters, MD PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient sampling

Other

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

Primary outcomes

  1. Clinical Features

    Time frame: 6 months

    Description of clinical, laboratory and radiological features of illness and complications.

  2. Immune host response at systemic level

    Time frame: 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.

  3. Immune host response at local level

    Time frame: 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).

  4. Host genetic variation

    Time frame: 6 months

    Identification of host genetic variants that are associated with severity of disease.

Secondary outcomes

  1. Comparison severe and non-severe COVID-19 hospitalised patients

    Time frame: 6 months

    Differences in baseline factors

  2. Comparison severe and non-severe COVID-19 hospitalised patients

    Time frame: 6 months

    Differences in immune characteristics

  3. Correlation of findings with outcome

    Time frame: 6 months

    Correlation of findings with outcome, aiming to identify early biomarkers of severe disease and putative targets for immunomodulatory therapy

  4. Correlation of immune profiling - microbiome

    Time frame: 6 months

    Correlation of immune profiling with microbiome analysis of patients

Study contacts

Contact information is provided by the study sponsor or research team.

Joost Wauters, MD PhD

CONTACT

[email protected]

003216344275

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: COntAGIouS

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Mar 31, 2020
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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