In-depth Immunological Investigation of COVID-19. (COntAGIouS)

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.

Study Overview

• Status: Recruiting
• Conditions: Coronavirus Infections
• Intervention / Treatment: Other: Patient sampling

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Joost Wauters, MD PhD; Phone Number: 003216344275; Email: joost.wauters@uzleuven.com

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Joost Wauters, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Features	Description of clinical, laboratory and radiological features of illness and complications.	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.	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).	6 months
Host genetic variation	Identification of host genetic variants that are associated with severity of disease.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison severe and non-severe COVID-19 hospitalised patients	Differences in baseline factors	6 months
Comparison severe and non-severe COVID-19 hospitalised patients	Differences in immune characteristics	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	6 months
Correlation of immune profiling - microbiome	Correlation of immune profiling with microbiome analysis of patients	6 months

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Joost Wauters, MD PhD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2020
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: COVID-19
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronaviridae Infections; Nidovirales Infections; COVID-19; Coronavirus Infections
• Other Study ID Numbers: COntAGIouS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No