In-depth Immunological Investigation of COVID-19.

Coronavirus Infections Clinical Trial

— COntAGIouS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04327570
• Other study ID #: COntAGIouS
• Status: Recruiting
• Start date: March 27, 2020
• Est. completion date: March 30, 2026

Study information

• Verified date: January 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Joost Wauters, MD PhD
• Phone: 003216344275
• Email: joost.wauters[@]uzleuven.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 directed medical interventions.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 30, 2026
• Est. primary completion date: March 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections

Intervention

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

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Features	Description of clinical, laboratory and radiological features of illness and complications.	6 months
Primary	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
Primary	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
Primary	Host genetic variation	Identification of host genetic variants that are associated with severity of disease.	6 months
Secondary	Comparison severe and non-severe COVID-19 hospitalised patients	Differences in baseline factors	6 months
Secondary	Comparison severe and non-severe COVID-19 hospitalised patients	Differences in immune characteristics	6 months
Secondary	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
Secondary	Correlation of immune profiling - microbiome	Correlation of immune profiling with microbiome analysis of patients	6 months