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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04579471
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : October 9, 2020
Sponsor:
Collaborators:
KU Leuven
Hasselt University
Ziekenhuis Oost-Limburg
Jessa Hospital
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Covid19 SARS-CoV Infection Transplantation Infection Diagnostic Test: SARS-CoV-2 IgG

Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Outcome of SARS-CoV-2 Infection in Solid Organ and Hematopoietic Cell Transplant Recipients: The COVITRA Study
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Transplanted patients
All patients who underwent solid organ or hematopoietic cell transplantation at UZ Leuven
 Diagnostic Test: SARS-CoV-2 IgG
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
 Diagnostic Test: SARS-CoV-2 IgG
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
 Diagnostic Test: SARS-CoV-2 IgG
Collection of clinical variables, assessment of IgG antibodies for SARS-CoV-2, plasma collection for translational immunology studies


Outcome Measures
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Primary Outcome Measures :
  1. Prevalence and risk-factors for SARS-CoV-2 infection [ Time Frame: inclusion during 4 months ]
    Prevalence and risk-factors for SARS-CoV-2 infection

  2. Prevalence and risk-factors for COVID-19 [ Time Frame: inclusion during 4 months ]
    Prevalence and risk-factors for COVID-19


Secondary Outcome Measures :
  1. Durability of IgG positivity [ Time Frame: 12 months ]
    Durability of IgG positivity/immunity


Biospecimen Retention:   Samples Without DNA
Collection and storage plasma samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients who underwent solid organ or hematopoietic transplantation at UZ Leuven and who give informed consent
Criteria

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
Contacts and Locations
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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): NCT04579471


Contacts
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Contact: Jef Verbeek, MD, PhD + 32 16 34 42 25 jef.verbeek@uzleuven.be
Contact: Natalie Van den Ende +32 16 340749 natalie.vandenende@uzleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact: Jef Verbeek, MD    +32 16 345845    jef.verbeek@uzleuven.be   
Contact: Natalie Vandenende    +32 16 34 07 49    natalie.vandenende@uzleuven.be   
Principal Investigator: Jef Verbeek, MD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
KU Leuven
Hasselt University
Ziekenhuis Oost-Limburg
Jessa Hospital
Investigators
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Principal Investigator: Jef Verbeek, MD, PhD UZ Leuven
More Information
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04579471    
Other Study ID Numbers: s64036
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020
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:
covid19
SARS-CoV Infection
transplantation
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Severe Acute Respiratory Syndrome
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Pneumonia, Viral
 Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases