An observational study in Covid19, Kidney Transplant; Complications and Kidney Transplant Failure and Rejection, sponsored by Heidelberg University. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-01-19.
Sponsored by Heidelberg University · Observational
The Covid-19 Serum Study is a prospective case-control study in
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
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 600 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Heidelberg University is the lead sponsor of 279 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Specific Inclusion Criteria for PRE-TX Covid-19 Serum Study:
Specific Inclusion Criteria for POST-TX Covid-19 Serum Study:
Exclusion Criteria:
Kidney or liver-transplanted patients being hospitalized due to an infection with SARS-CoV-2
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)
Patients being kidney or liver-transplanted after having had an infection with SARS-CoV-2
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
Change in dnDSA development (PRE-TX Covid-19 Serum Study)
Time frame: Year 1, 2, 3, 5 after day of transplantation
Change in dnDSA development (POST-TX Covid-19 Serum Study)
Time frame: 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)
Time frame: Year 1, 2, 3, 5 after day of transplantation
Graft Survival (Post-TX Covid-19 Serum-Study)
Time frame: at day 60-90 after being hospitalized due to Covid-19; 1,2,3,5 years after day of hospitalization due to Covid-19
Incidence of graft rejection (PRE-TX Covid-19 Serum Study)
Time frame: Year 1, 2, 3, 5 after day of transplantation
Incidence of graft rejection (POST-TX Covid-19 Serum Study)
Time frame: at day 60-90 after being hospitalized due to Covid-19; 1,2,3,5 years after day of hospitalization due to Covid-19
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Heidelberg University