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

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

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.

Study Overview

• Status: Unknown
• Conditions: Covid19; SARS-CoV Infection; Transplantation Infection
• Intervention / Treatment: Diagnostic test: SARS-CoV-2 IgG

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• Belgium
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • Recruiting
      • UZ Leuven
      • Contact: Jef Verbeek, MD; Phone Number: +32 16 345845; Email: jef.verbeek@uzleuven.be
      • Contact: Natalie Vandenende; Phone Number: +32 16 34 07 49; Email: natalie.vandenende@uzleuven.be
      • Principal Investigator: Jef Verbeek, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: KU Leuven; Hasselt University; Jessa Hospital; Ziekenhuis Oost-Limburg
• Investigators: Principal Investigator: Jef Verbeek, MD, PhD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): October 9, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: covid19; SARS-CoV Infection; transplantation
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Severe Acute Respiratory Syndrome; COVID-19; Infections; Communicable Diseases
• Other Study ID Numbers: s64036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No