In-depth Immunological Investigation of COVID-19.

NCT04327570 | Recruiting

• 1 other identifier: COntAGIouS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infections

Keywords

COVID-19

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Comparison severe and non-severe COVID-19 hospitalised patients

  6 months

• Comparison severe and non-severe COVID-19 hospitalised patients

  6 months

• Correlation of findings with outcome

  6 months

• Correlation of immune profiling - microbiome

  6 months

Study Arms (2)

ICU-hospitalised COVID-19 patients

COVID-19 positive patients hospitalised in intensive care ('severe disease').

Other: Patient sampling

ward-hospitalised COVID-19 patients

COVID-19 positive patients requiring hospitalisation,not on intensive care department ('non-severe').

Other: Patient sampling

Interventions

Patient sampling OTHER

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

ICU-hospitalised COVID-19 patients; ward-hospitalised COVID-19 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients \>/= 18 years old AND
• Hospitalised with PCR-confirmed and/or CT-confirmed SARS-CoV-2 disease

You may not qualify if:

• Age \< 18 years old
• No informed consent

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, plasma, PBMC, BAL, lung tissue

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Joost Wauters, MD PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joost Wauters, MD PhD

CONTACT

003216344275; joost.wauters@uzleuven.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 31, 2020
• Study Start: March 27, 2020
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2028
• Last Updated: April 29, 2026

Record last verified: 2025-10

Locations

BE (1)