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

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ClinicalTrials.gov Identifier: NCT04327570
Recruitment Status : Recruiting
First Posted : March 31, 2020
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen 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.

Condition or disease Intervention/treatment
Coronavirus Infections 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: In-depth Characterisation of the Dynamic Host Immune Response to Coronavirus SARS-CoV-2
Actual Study Start Date : March 27, 2020
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : March 30, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Clinical Features [ Time Frame: 6 months ]
    Description of clinical, laboratory and radiological features of illness and complications.

  2. Immune host response at systemic level [ Time Frame: 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.

  3. Immune host response at local level [ Time Frame: 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).

  4. Host genetic variation [ Time Frame: 6 months ]
    Identification of host genetic variants that are associated with severity of disease.


Secondary Outcome Measures :
  1. Comparison severe and non-severe COVID-19 hospitalised patients [ Time Frame: 6 months ]
    Differences in baseline factors

  2. Comparison severe and non-severe COVID-19 hospitalised patients [ Time Frame: 6 months ]
    Differences in immune characteristics

  3. Correlation of findings with outcome [ Time Frame: 6 months ]
    Correlation of findings with outcome, aiming to identify early biomarkers of severe disease and putative targets for immunomodulatory therapy

  4. Correlation of immune profiling - microbiome [ Time Frame: 6 months ]
    Correlation of immune profiling with microbiome analysis of patients


Biospecimen Retention:   Samples With DNA
Blood, plasma, PBMC, BAL, lung tissue


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All non-immunosuppressed* consecutive patients (>18 years old) that are admitted to UZ Leuven from March 2020 until September 2020 with PCR-confirmed and/or CT-confirmed SARS-CoV-2 disease are eligible for inclusion.
Criteria

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
  • Patients on cyclosporine/tacrolimus/sirolimus/everolimus therapy*

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04327570


Contacts
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Contact: Joost Wauters, MD PhD 003216344275 joost.wauters@uzleuven.com

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Joost Wauters, MD PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Joost Wauters, MD PhD UZ Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04327570    
Other Study ID Numbers: COntAGIouS
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
COVID-19
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases