Prevalence and Outcome of SARS-CoV-2 Infection & COVID-19 in Transplant Recipients: The COVITRA Study

NCT ID: NCT04579471

Last Updated: 2024-07-03

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

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2025-12-31

Brief Summary

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This project will provide novel data using a large cohort of more than 3000 transplanted patients. Risk and protective factors for SARS-CoV-2 infection and COVID-19 disease severity will be identified. The proportion of patients who develop antibodies after infection will be revealed. In this way the presence of these antibodies can be evaluated as a test for prior infection. Our study additionally will demonstrate how long these antibodies remain present and whether they are protective against a new infection.

Detailed Description

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Conditions

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Covid19 SARS-CoV Infection Transplantation Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Transplanted patients

All patients who underwent solid organ or hematopoietic cell transplantation at UZ Leuven

SARS-CoV-2 IgG

Intervention Type DIAGNOSTIC_TEST

Collection of clinical variables, assessment of IgG antibodies for SARS-CoV-2, plasma collection for translational immunology studies

Transplanted patients with past SARS-CoV-2 infection

Transplanted patients with past SARS-CoV-2 infection will be followed for one year (at month 3, 6 and 12 after the initial study visit) to assess durability of IgG positivity

SARS-CoV-2 IgG

Intervention Type DIAGNOSTIC_TEST

Collection of clinical variables, assessment of IgG antibodies for SARS-CoV-2, plasma collection for translational immunology studies

Transplanted patients without past SARS-CoV-2 infection

100 transplanted patients without past SARS-CoV-2 infection will be followed for one year (at month 3, 6 and 12 after the initial study visit) to assess durability of IgG positivity and as control for the transplanted patients with WITH past SARS-CoV-2 infection

SARS-CoV-2 IgG

Intervention Type DIAGNOSTIC_TEST

Collection of clinical variables, assessment of IgG antibodies for SARS-CoV-2, plasma collection for translational immunology studies

Interventions

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SARS-CoV-2 IgG

Collection of clinical variables, assessment of IgG antibodies for SARS-CoV-2, plasma collection for translational immunology studies

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* all patients who underwent solid organ or hematopoietic cell transplantation at UZ Leuven and who give informed consent

Exclusion Criteria

* age under 18 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KU Leuven

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role collaborator

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role collaborator

Jessa Hospital

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jef Verbeek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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UZ Leuven

Leuven, Vlaams Brabant, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Jef Verbeek, MD, PhD

Role: CONTACT

+ 32 16 34 42 25

Natalie Van den Ende

Role: CONTACT

+32 16 340749

Facility Contacts

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Jef Verbeek, MD

Role: primary

+32 16 345845

Natalie Vandenende

Role: backup

+32 16 34 07 49

Other Identifiers

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s64036

Identifier Type: -

Identifier Source: org_study_id

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