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

Recruiting

• Conditions: Covid19; SARS-CoV Infection; Transplantation Infection
• Interventions: Diagnostic Test: SARS-CoV-2 IgG

• Registration Number: NCT04579471
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-06
• Study First Posted: 2020-10-08
• Primary Completion: 2021-12-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

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

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Exclusion Criteria

• age under 18 years

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transplanted patients	SARS-CoV-2 IgG	All patients who underwent solid organ or hematopoietic cell transplantation at UZ Leuven
Transplanted patients with past SARS-CoV-2 infection	SARS-CoV-2 IgG	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	SARS-CoV-2 IgG	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

Primary Outcome Measures

Name	Time	Method
Prevalence and risk-factors for SARS-CoV-2 infection	inclusion during 4 months	Prevalence and risk-factors for SARS-CoV-2 infection
Prevalence and risk-factors for COVID-19	inclusion during 4 months	Prevalence and risk-factors for COVID-19

Secondary Outcome Measures

Name	Time	Method
Durability of IgG positivity	12 months	Durability of IgG positivity/immunity

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Vlaams Brabant, Belgium