Prevalence and Outcome of SARS-CoV-2 Infection & COVID-19 in Transplant Recipients: The COVITRA Study
COVITRA
1 other identifier
observational
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 6, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJuly 3, 2024
July 1, 2024
1.5 years
October 6, 2020
July 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Prevalence and risk-factors for SARS-CoV-2 infection
Prevalence and risk-factors for SARS-CoV-2 infection
inclusion during 4 months
Prevalence and risk-factors for COVID-19
Prevalence and risk-factors for COVID-19
inclusion during 4 months
Secondary Outcomes (1)
Durability of IgG positivity
12 months
Study Arms (3)
Transplanted patients
All patients who underwent solid organ or hematopoietic cell transplantation at UZ Leuven
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
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
Interventions
Collection of clinical variables, assessment of IgG antibodies for SARS-CoV-2, plasma collection for translational immunology studies
Eligibility Criteria
all patients who underwent solid organ or hematopoietic transplantation at UZ Leuven and who give informed consent
You may qualify if:
- all patients who underwent solid organ or hematopoietic cell transplantation at UZ Leuven and who give informed consent
You may not qualify if:
- age under 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitaire Ziekenhuizen KU Leuvenlead
- KU Leuvencollaborator
- Hasselt Universitycollaborator
- Ziekenhuis Oost-Limburgcollaborator
- Jessa Hospitalcollaborator
Study Sites (1)
UZ Leuven
Leuven, Vlaams Brabant, 3000, Belgium
Biospecimen
Collection and storage plasma samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jef Verbeek, MD, PhD
UZ Leuven
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2020
First Posted
October 8, 2020
Study Start
July 1, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2025
Last Updated
July 3, 2024
Record last verified: 2024-07