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

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Recruiting

CT.gov ID

NCT04579471

Collaborator

KU Leuven (Other), Hasselt University (Other), Ziekenhuis Oost-Limburg (Other), Jessa Hospital (Other)

2,000

Enrollment

Location

Anticipated Duration (Months)

111.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 SARS-CoV Infection Transplantation Infection	Diagnostic Test: SARS-CoV-2 IgG

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Transplanted patients All patients who underwent solid organ or hematopoietic cell transplantation at UZ Leuven	Diagnostic Test: SARS-CoV-2 IgG Collection of clinical variables, assessment of IgG antibodies for SARS-CoV-2, plasma collection for translational immunology studies
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	Diagnostic Test: SARS-CoV-2 IgG Collection of clinical variables, assessment of IgG antibodies for SARS-CoV-2, plasma collection for translational immunology studies
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	Diagnostic Test: SARS-CoV-2 IgG Collection of clinical variables, assessment of IgG antibodies for SARS-CoV-2, plasma collection for translational immunology studies

Arm

Intervention/Treatment

Transplanted patients

All patients who underwent solid organ or hematopoietic cell transplantation at UZ Leuven

Diagnostic Test: SARS-CoV-2 IgG

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

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

Diagnostic Test: SARS-CoV-2 IgG

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

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

Diagnostic Test: SARS-CoV-2 IgG

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

Outcome Measures

Primary Outcome Measures

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

Durability of IgG positivity [12 months]
Durability of IgG positivity/immunity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Leuven	Leuven	Vlaams Brabant	Belgium	3000

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven
KU Leuven
Hasselt University
Ziekenhuis Oost-Limburg
Jessa Hospital

Investigators

Principal Investigator: Jef Verbeek, MD, PhD, UZ Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitaire Ziekenhuizen Leuven

ClinicalTrials.gov Identifier:

NCT04579471

Other Study ID Numbers:

s64036

First Posted:

Oct 8, 2020

Last Update Posted:

Oct 9, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Universitaire Ziekenhuizen Leuven

covid19

SARS-CoV Infection

transplantation

Additional relevant MeSH terms:

Infections

Communicable Diseases

COVID-19

Severe Acute Respiratory Syndrome

Study Results

No Results Posted as of Oct 9, 2020