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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04579471
Other study ID # s64036
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date December 31, 2021

Study information

Verified date October 2020
Source Universitaire Ziekenhuizen Leuven
Contact Jef Verbeek, MD, PhD
Phone + 32 16 34 42 25
Email jef.verbeek@uzleuven.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Belgium UZ Leuven Leuven Vlaams Brabant

Sponsors (5)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven Hasselt University, Jessa Hospital, KU Leuven, Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence and risk-factors for SARS-CoV-2 infection Prevalence and risk-factors for SARS-CoV-2 infection inclusion during 4 months
Primary Prevalence and risk-factors for COVID-19 Prevalence and risk-factors for COVID-19 inclusion during 4 months
Secondary Durability of IgG positivity Durability of IgG positivity/immunity 12 months
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