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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04694573
• Other study ID #: CTS Covid-19 Serum Studies
• Status: Recruiting
• Start date: December 28, 2020
• Est. completion date: December 28, 2022

Study information

• Verified date: January 2021
• Source: Heidelberg University
• Contact: Caner Suesal, Professor
• Phone: +49 (0) 6221 56-5545
• Email: caner.suesal[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 28, 2022
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Nierenzentrum Heidelberg	Heidelberg	DE

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in dnDSA development (PRE-TX Covid-19 Serum Study)		Year 1, 2, 3, 5 after day of transplantation
Primary	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
Primary	Graft Survival (PRE-TX Covid-19 Serum-Study)		Year 1, 2, 3, 5 after day of transplantation
Primary	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	Incidence of graft rejection (PRE-TX Covid-19 Serum Study)		Year 1, 2, 3, 5 after day of transplantation
Secondary	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