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

Covid19 Clinical Trial

— COVITRA  

Official title:

Prevalence and Outcome of SARS-CoV-2 Infection in Solid Organ and Hematopoietic Cell Transplant Recipients: The COVITRA Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04579471
• Other study ID #: s64036
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infections
• Covid19
• Infection
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome
• Transplantation Infection

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