Covid19COVITRANCT04579471
Prevalence and Outcome of SARS-CoV-2 Infection & COVID-19 in Transplant Recipients: The COVITRA Study
An observational study of Covid19 and SARS-CoV Infection, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Covid19, SARS-CoV Infection, Transplantation Infection
- What is being tested?
- SARS-CoV-2 IgG
- How many people
- 2,000 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients who underwent solid organ or hematopoietic transplantation at UZ Leuven and who give informed consent
Who may be able to join
- all patients who underwent solid organ or hematopoietic cell transplantation at UZ Leuven and who give informed consent
Who cannot join
- age under 18 years
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, Vlaams Brabant, 3000
Jef Verbeek, MD, +32 16 345845, jef.verbeek@uzleuven.be
Natalie Vandenende, +32 16 34 07 49, natalie.vandenende@uzleuven.be
About this study
Official title: 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.
- Conditions
- Covid19, SARS-CoV Infection, Transplantation Infection
- Being tested
- SARS-CoV-2 IgG
- Keywords
- covid19, SARS-CoV Infection, transplantation
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 IgGDiagnostic test
Collection of clinical variables, assessment of IgG antibodies for SARS-CoV-2, plasma collection for translational immunology studies
| Study group | Role | What they receive |
|---|---|---|
| Transplanted patients | All patients who underwent solid organ or hematopoietic cell transplantation at UZ Leuven Receives: Diagnostic Test: SARS-CoV-2 IgG | |
| 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 Receives: Diagnostic Test: SARS-CoV-2 IgG | |
| 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 Receives: Diagnostic Test: SARS-CoV-2 IgG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and risk-factors for SARS-CoV-2 infection
Prevalence and risk-factors for SARS-CoV-2 infection
Measured: inclusion during 4 months
Prevalence and risk-factors for COVID-19
Prevalence and risk-factors for COVID-19
Measured: inclusion during 4 months
Secondary outcomes (1)
Durability of IgG positivity
Durability of IgG positivity/immunity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Hasselt University, Ziekenhuis Oost-Limburg, Jessa Hospital
- Responsible party
- Sponsor
- Investigators
- Jef Verbeek, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579471
- Sponsor's protocol ID
- s64036
- Acronym
- COVITRA
- Status last verified
- Jul 2024
- First submitted
- 6 Oct 2020
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Outcome of SARS-CoV-2 Infection in Solid Organ and Hematopoietic Cell Transplant Recipients: The COVITRA Study
- ClinicalTrials.gov ID
- NCT04579471
- Acronym / sponsor ID
- COVITRA / s64036
- Conditions
- Covid19, SARS-CoV Infection, Transplantation Infection
- Keywords
- covid19, SARS-CoV Infection, transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven, Hasselt University, Ziekenhuis Oost-Limburg, Jessa Hospital
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transplanted patients | – | Diagnostic Test: SARS-CoV-2 IgGAll patients who underwent solid organ or hematopoietic cell transplantation at UZ Leuven |
| Transplanted patients with past SARS-CoV-2 infection | – | Diagnostic Test: SARS-CoV-2 IgGTransplanted 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 | – | Diagnostic Test: SARS-CoV-2 IgG100 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients who underwent solid organ or hematopoietic transplantation at UZ Leuven and who give informed consent
Key inclusion criteria (1 listed)
- all patients who underwent solid organ or hematopoietic cell transplantation at UZ Leuven and who give informed consent
Key exclusion criteria (1 listed)
- age under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 IgGCollection of clinical variables, assessment of IgG antibodies for SARS-CoV-2, plasma collection for translational immunology studies | Diagnostic test | Transplanted patients, Transplanted patients with past SARS-CoV-2 infection, Transplanted patients without past SARS-CoV-2 infection |
Primary outcome
Prevalence and risk-factors for SARS-CoV-2 infection
Time frame: inclusion during 4 months
Prevalence and risk-factors for SARS-CoV-2 infection
Prevalence and risk-factors for COVID-19
Time frame: inclusion during 4 months
Prevalence and risk-factors for COVID-19
1 secondary outcome
Durability of IgG positivity
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jef Verbeek, MD, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and SARS-CoV Infection, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jef Verbeek, MD, PhD (+ 32 16 34 42 25, jef.verbeek@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and risk-factors for SARS-CoV-2 infection (time frame: inclusion during 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.