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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04694573

Enrollment

600

Registered

2021-01-05

Start date

2020-12-28

Completion date

2022-12-28

Last updated

2021-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Germany

Contacts

Primary ContactCaner Suesal, Professor

caner.suesal@med.uni-heidelberg.de+49 (0) 6221 56-5545

Backup ContactChristian Morath, Professor

christian.morath@med.uni-heidelberg.de+49 (0) 6221 91120

Outcome results