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The Covid-19 Serum Study is a prospective case-control study in
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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POST-TX Covid-19 Serum Study Case | Kidney or liver-transplanted patients being hospitalized due to an infection with SARS-CoV-2 | ||
| POST-TX Covid-19 Serum Study Control | 2 matched controls without SARS-CoV-2 infection after TX; matching according to
| ||
| PRE-TX Covid-19 Serum Study Case | Patients being kidney or liver-transplanted after having had an infection with SARS-CoV-2 | ||
| PRE-TX Covid-19 Serum Study Control | 2 matched controls without SARS-CoV-2 infection prior to TX; matching according to
|
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| Measure | Description | Time Frame |
|---|---|---|
| Change in dnDSA development (PRE-TX Covid-19 Serum Study) | Year 1, 2, 3, 5 after day of transplantation | |
| Change in dnDSA development (POST-TX Covid-19 Serum Study) | at day 60-90 after being hospitalized due to Covid-19; 1,2,3,5 years after day of hospitalization due to Covid-19 | |
| Graft Survival (PRE-TX Covid-19 Serum-Study) | Year 1, 2, 3, 5 after day of transplantation | |
| Graft Survival (Post-TX Covid-19 Serum-Study) | at day 60-90 after being hospitalized due to Covid-19; 1,2,3,5 years after day of hospitalization due to Covid-19 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of graft rejection (PRE-TX Covid-19 Serum Study) | Year 1, 2, 3, 5 after day of transplantation | |
| Incidence of graft rejection (POST-TX Covid-19 Serum Study) | at day 60-90 after being hospitalized due to Covid-19; 1,2,3,5 years after day of hospitalization due to Covid-19 |
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Inclusion Criteria:
Specific Inclusion Criteria for PRE-TX Covid-19 Serum Study:
Specific Inclusion Criteria for POST-TX Covid-19 Serum Study:
Exclusion Criteria:
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Kidney- or liver transplant recipients with a SARS-CoV-2 infection prior to transplantation (PRE-TX Covid-19 Serum Study) or a SARS-CoV-2 infection after transplantation (POST-TX Covid-19 Serum Study), 2 matched controls
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caner Suesal, Professor | Contact | +49 (0) 6221 56-5545 | caner.suesal@med.uni-heidelberg.de | |
| Christian Morath, Professor | Contact | +49 (0) 6221 91120 | christian.morath@med.uni-heidelberg.de |
| Name | Affiliation | Role |
|---|---|---|
| Caner Suesal, Professor | Institute of Immunology Heidelberg | Principal Investigator |
| Christian Morath, Professor | Department of Nephrology, Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nierenzentrum Heidelberg | Recruiting | Heidelberg | DE | 69120 | Germany |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Serum; EDTA
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |