NCT04694573

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
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 2020-12-28
• Primary completion: 2021-12-28
• Completion: 2022-12-28
• First posted: 2021-01-05
• Last updated: 2021-01-19

Locations

1 site across 1 country: Germany