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

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

• Registration Number: NCT04694573
• Lead Sponsor: Heidelberg University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-28
• Study First Submitted: 2020-12-28
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-03
• Study First Posted: 2021-01-05
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-19
• Primary Completion: 2021-12-28
• Study Completion: 2022-12-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Nierenzentrum Heidelberg; 🇩🇪 Heidelberg, DE, Germany