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

Heidelberg University

Status: Unknown

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

Study type: Observational

Funder types: Other

Identifiers

NCT04694573

CTS Covid-19 Serum Studies

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

600 participants in 4 patient groups

POST-TX Covid-19 Serum Study Case

Description:

Kidney or liver-transplanted patients being hospitalized due to an infection with SARS-CoV-2

POST-TX Covid-19 Serum Study Control

Description:

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

Description:

Patients being kidney or liver-transplanted after having had an infection with SARS-CoV-2

PRE-TX Covid-19 Serum Study Control

Description:

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