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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Caner Suesal, Professor; Phone Number: +49 (0) 6221 56-5545; Email: caner.suesal@med.uni-heidelberg.de
• Study Contact Backup: Name: Christian Morath, Professor; Phone Number: +49 (0) 6221 91120; Email: christian.morath@med.uni-heidelberg.de

Study Locations

• Germany
  • DE
    • Heidelberg, DE, Germany, 69120
      • Recruiting
      • Nierenzentrum Heidelberg
      • Contact: Christian Morath, Professor; Phone Number: +49 (0)6221-91120; Email: christian.morath@med.uni-heidelberg.de
      • Contact: Louise Benning, Dr.med.; Email: louise.benning@med.uni-heidelberg.de
      • Principal Investigator: Christian Morath, Professor
      • Principal Investigator: Caner Süsal, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
POST-TX Covid-19 Serum Study Case; Kidney or liver-transplanted patients being hospitalized due to an infection with SARS-CoV-2
POST-TX Covid-19 Serum Study Control; 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; Patients being kidney or liver-transplanted after having had an infection with SARS-CoV-2
PRE-TX Covid-19 Serum Study Control; 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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Heidelberg University
• Investigators: Principal Investigator: Caner Suesal, Professor, Institute of Immunology Heidelberg; Principal Investigator: Christian Morath, Professor, Department of Nephrology, Heidelberg

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2020
• Primary Completion (Anticipated): December 28, 2021
• Study Completion (Anticipated): December 28, 2022

Study Registration Dates

• First Submitted: December 28, 2020
• First Submitted That Met QC Criteria: January 3, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Covid-19; Kidney Transplantation; Liver Transplantation; donor-specific antibodies; dnDSA
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CTS Covid-19 Serum Studies

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No