In-depth Immunological Investigation of COVID-19.

NCT ID: NCT04327570

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-27

Study Completion Date

2026-03-30

Brief Summary

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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

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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

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Coronavirus Infections

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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ICU-hospitalised COVID-19 patients

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

Patient sampling

Intervention Type OTHER

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').

Patient sampling

Intervention Type OTHER

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

Interventions

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Patient sampling

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joost Wauters, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Joost Wauters, MD PhD

Role: CONTACT

003216344275

Facility Contacts

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Joost Wauters, MD PhD

Role: primary

Other Identifiers

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COntAGIouS

Identifier Type: -

Identifier Source: org_study_id

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