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

Study Overview
=================
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.

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

Conditions
-----------------
Covid19, SARS-CoV Infection, Transplantation Infection

Intervention / Treatment
-----------------
* Diagnostic Test: SARS-CoV-2 IgG


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transplanted patients<br>All patients who underwent solid organ or hematopoietic cell transplantation at UZ Leuven | Diagnostic Test: SARS-CoV-2 IgG<br>* Collection of clinical variables, assessment of IgG antibodies for SARS-CoV-2, plasma collection for translational immunology studies<br>|
| Transplanted patients with past SARS-CoV-2 infection<br>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<br>* Collection of clinical variables, assessment of IgG antibodies for SARS-CoV-2, plasma collection for translational immunology studies<br>|
| Transplanted patients without past SARS-CoV-2 infection<br>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<br>* Collection of clinical variables, assessment of IgG antibodies for SARS-CoV-2, plasma collection for translational immunology studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Durability of IgG positivity | Durability of IgG positivity/immunity | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
covid19, SARS-CoV Infection, transplantation