In-depth Immunological Investigation of COVID-19.

Recruiting

• Conditions: Coronavirus Infections
• Interventions: Other: Patient sampling

• Registration Number: NCT04327570
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

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 Timeline

• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-26
• Study Start: 2020-03-27
• Study First Posted: 2020-03-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-10
• Primary Completion: 2026-03-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU-hospitalised COVID-19 patients	Patient sampling	COVID-19 positive patients hospitalised in intensive care ('severe disease').
ward-hospitalised COVID-19 patients	Patient sampling	COVID-19 positive patients requiring hospitalisation,not on intensive care department ('non-severe').

Primary Outcome Measures

Name	Time	Method
Clinical Features	6 months	Description of clinical, laboratory and radiological features of illness and complications.
Immune host response at systemic level	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.
Immune host response at local level	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).
Host genetic variation	6 months	Identification of host genetic variants that are associated with severity of disease.

Secondary Outcome Measures

Name	Time	Method
Correlation of immune profiling - microbiome	6 months	Correlation of immune profiling with microbiome analysis of patients
Comparison severe and non-severe COVID-19 hospitalised patients	6 months	Differences in immune characteristics
Correlation of findings with outcome	6 months	Correlation of findings with outcome, aiming to identify early biomarkers of severe disease and putative targets for immunomodulatory therapy

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium