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NCT Number: NCT04579471

Prevalence and Outcome of SARS-CoV-2 Infection & COVID-19 in 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.

Recruiting

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV Infection Severe Acute Respiratory Syndrome Transplantation Infection Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SARS-CoV-2 IgG

Diagnostic Test

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

Primary outcomes

  1. Prevalence and risk-factors for SARS-CoV-2 infection

    Time frame: inclusion during 4 months

    Prevalence and risk-factors for SARS-CoV-2 infection

  2. Prevalence and risk-factors for COVID-19

    Time frame: inclusion during 4 months

    Prevalence and risk-factors for COVID-19

Secondary outcomes

  1. Durability of IgG positivity

    Time frame: 12 months

    Durability of IgG positivity/immunity

Study contacts

Contact information is provided by the study sponsor or research team.

Jef Verbeek, MD, PhD

CONTACT

[email protected]

+ 32 16 34 42 25

Natalie Van den Ende

CONTACT

[email protected]

+32 16 340749

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Hasselt University
  • Jessa Hospital
  • KU Leuven
  • Ziekenhuis Oost-Limburg

Registry information

Official study title

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

Acronym: COVITRA

Important dates

Study start
2020
Primary completion
2021
Study completion
2025
First posted
Oct 8, 2020
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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