Multicenter CTS Pre-and Post-Transplantation Covid-19 Serum Studies
NCT ID: NCT04694573
Last Updated: 2021-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
600 participants
OBSERVATIONAL
2020-12-28
2022-12-28
Brief Summary
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1. kidney or liver transplanted patients being hospitalized due to an infection with Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2) after transplantation (TX) (POST-TX Covid-19 Serum Study)
or
2. patients receiving kidney or liver transplantation after having had a SARS-CoV-2 infection (PRE-TX Covid-19 Serum Study)
The aim of this study is to evaluate the development of de novo donor specific antibodies (dnDSA) in transplanted patients being hospitalized due to an infection with SARS-CoV-2 (POST-TX Covid-19 Serum Study) as well as in patients receiving kidney or liver transplantation after having had an infection with SARS-CoV-2 prior to transplantation (PRE-TX Covid-19 Serum Study).
Further, the investigators will evaluate possible consequences of having had a SARS-CoV-2 infection prior or after liver or kidney transplantation with regard to graft survival and incidence of graft rejection episodes as well as SARS-CoV-2 specific antibody development after SARS-CoV-2 infection.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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POST-TX Covid-19 Serum Study Case
Kidney or liver-transplanted patients being hospitalized due to an infection with SARS-CoV-2
No interventions assigned to this group
POST-TX Covid-19 Serum Study Control
2 matched controls without SARS-CoV-2 infection after TX; matching according to
* age (18-34, 35-59, 60-75 years)
* sex
* type of transplantation
* time after transplantation (0-180, 181-365, 366-1095, 1096-2555, \>2555 days after TX)
No interventions assigned to this group
PRE-TX Covid-19 Serum Study Case
Patients being kidney or liver-transplanted after having had an infection with SARS-CoV-2
No interventions assigned to this group
PRE-TX Covid-19 Serum Study Control
2 matched controls without SARS-CoV-2 infection prior to TX; matching according to
* age(18-34, 35-59, 60-75 years)
* sex
* type of transplantation
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Participant or legal guardian is willing and able to give informed consent for participation in the trial
* SARS-CoV-2 infection before transplantation (PRE-TX Covid-19 Serum Study) or after transplantation (POST-TX Covid-19 Serum Study)
* Kidney or liver transplantation between Dec 17,2020 - Dec 17, 2021
* Hospitalization due to SARS-CoV-2 infection in between Dec 17,2020 - Dec 17, 2021
* multi-organ transplant recipients
18 Years
75 Years
ALL
No
Sponsors
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Heidelberg University
OTHER
Responsible Party
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Caner Suesal
Professor, Institute of Immunology
Principal Investigators
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Caner Suesal, Professor
Role: PRINCIPAL_INVESTIGATOR
Institute of Immunology Heidelberg
Christian Morath, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Nephrology, Heidelberg
Locations
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Nierenzentrum Heidelberg
Heidelberg, DE, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CTS Covid-19 Serum Studies
Identifier Type: -
Identifier Source: org_study_id
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