Multicenter CTS Pre-and Post-Transplantation Covid-19 Serum Studies

Study Overview
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Brief Summary
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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.

Official Title
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Collaborative Transplant Study (CTS) Pre- and Post-Transplantation Covid-19 Serum Studies: Antibody Development Following a SARS-CoV-2 Infection

Conditions
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Covid19, Kidney Transplant; Complications, Kidney Transplant Failure and Rejection, Liver Transplant; Complications, Liver Transplant Failure and Rejection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Kidney-transplant recipients and full-size liver-recipients (de-novo or re-transplanted) 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) Specific Inclusion Criteria for PRE-TX Covid-19 Serum Study: Kidney or liver transplantation between Dec 17,2020 - Dec 17, 2021 Specific Inclusion Criteria for POST-TX Covid-19 Serum Study: Hospitalization due to SARS-CoV-2 infection in between Dec 17,2020 - Dec 17, 2021 Exclusion Criteria: Participants not meeting the inclusion criteria multi-organ transplant recipients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| POST-TX Covid-19 Serum Study Case<br>Kidney or liver-transplanted patients being hospitalized due to an infection with SARS-CoV-2 | |
| POST-TX Covid-19 Serum Study Control<br>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) | |
| PRE-TX Covid-19 Serum Study Case<br>Patients being kidney or liver-transplanted after having had an infection with SARS-CoV-2 | |
| PRE-TX Covid-19 Serum Study Control<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19, SARS-CoV-2, Kidney Transplantation, Liver Transplantation, donor-specific antibodies, dnDSA