Coronavirus InfectionsCOntAGIouSNCT04327570
In-depth Immunological Investigation of COVID-19.
An observational study of Coronavirus Infections, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infections
- What is being tested?
- Patient sampling
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Mar 2020to 30 Mar 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Patients >/= 18 years old AND
- Hospitalised with PCR-confirmed and/or CT-confirmed SARS-CoV-2 disease
Who cannot join
- Age < 18 years old
- No informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Joost Wauters, MD PhD
About this study
Official title: In-depth Characterisation of the Dynamic Host Immune Response to Coronavirus SARS-CoV-2
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.
Read the 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.
- Conditions
- Coronavirus Infections
- Being tested
- Patient sampling
- Keywords
- COVID-19
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient samplingOther
Blood draw, NP/rectal swab, bronchoscopy if clinically indicated, lung tissue if applicable
| Study group | Role | What they receive |
|---|---|---|
| ICU-hospitalised COVID-19 patients | COVID-19 positive patients hospitalised in intensive care ('severe disease'). Receives: Other: Patient sampling | |
| ward-hospitalised COVID-19 patients | COVID-19 positive patients requiring hospitalisation,not on intensive care department ('non-severe'). Receives: Other: Patient sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Features
Description of clinical, laboratory and radiological features of illness and complications.
Measured: 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.
Measured: 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).
Measured: 6 months
Host genetic variation
Identification of host genetic variants that are associated with severity of disease.
Measured: 6 months
Secondary outcomes (4)
Comparison severe and non-severe COVID-19 hospitalised patients
Differences in baseline factors
Measured: 6 months
Comparison severe and non-severe COVID-19 hospitalised patients
Differences in immune characteristics
Measured: 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
Measured: 6 months
Correlation of immune profiling - microbiome
Correlation of immune profiling with microbiome analysis of patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start27 Mar 2020
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joost Wauters, MD PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327570
- Sponsor's protocol ID
- COntAGIouS
- Acronym
- COntAGIouS
- Status last verified
- Oct 2025
- First submitted
- 26 Mar 2020
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 41566340