Clinical trial NCT04694573: Multicenter CTS Pre-and Post-Transplantation Covid-19 Serum Studies
Official title: Collaborative Transplant Study (CTS) Pre- and Post-Transplantation Covid-19 Serum Studies: Antibody Development Following a SARS-CoV-2 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Kidney Transplant; Complications
Kidney Transplant Failure and Rejection
Liver Transplant; Complications
Liver Transplant Failure and Rejection
Keywords: Covid-19
SARS-CoV-2
Kidney Transplantation
Liver Transplantation
donor-specific antibodies
dnDSA
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: The Covid-19 Serum Study is a prospective case-control study in

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in dnDSA development (PRE-TX Covid-19 Serum Study)
timeFrame: Year 1, 2, 3, 5 after day of transplantation
measure: Change in dnDSA development (POST-TX Covid-19 Serum Study)
timeFrame: 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: Graft Survival (PRE-TX Covid-19 Serum-Study)
timeFrame: Year 1, 2, 3, 5 after day of transplantation
measure: Graft Survival (Post-TX Covid-19 Serum-Study)
timeFrame: 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 outcomes:
measure: Incidence of graft rejection (PRE-TX Covid-19 Serum Study)
timeFrame: Year 1, 2, 3, 5 after day of transplantation
measure: Incidence of graft rejection (POST-TX Covid-19 Serum Study)
timeFrame: at day 60-90 after being hospitalized due to Covid-19; 1,2,3,5 years after day of hospitalization due to Covid-19
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Nierenzentrum Heidelberg
state: DE
Study officials:
affiliation: Institute of Immunology Heidelberg
name: Caner Suesal, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, Heidelberg
name: Christian Morath, Professor
role: PRINCIPAL_INVESTIGATOR
References: