Collaborative Transplant Study (CTS) Pre- and Post-Transplantation Covid-19 Serum Studies: Antibody Development Following a SARS-CoV-2 Infection
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Change in dnDSA development (PRE-TX Covid-19 Serum Study)
研究概览
简要总结
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 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Participants not meeting the inclusion criteria
- •multi-organ transplant recipients
结局指标
主要结局
Change in dnDSA development (PRE-TX Covid-19 Serum Study)
时间窗: Year 1, 2, 3, 5 after day of transplantation
Change in dnDSA development (POST-TX Covid-19 Serum Study)
时间窗: 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)
时间窗: Year 1, 2, 3, 5 after day of transplantation
Graft Survival (Post-TX Covid-19 Serum-Study)
时间窗: at day 60-90 after being hospitalized due to Covid-19; 1,2,3,5 years after day of hospitalization due to Covid-19
次要结局
- 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)
研究者
Caner Suesal
Professor, Institute of Immunology
Heidelberg University