EVALUATION OF COVID-19 VACCINATION EFFICACY AND CONTIXAGEVIMAB-CILGAVIMAB PROPHYLAXIS IN LIVER AND KIDNEY TRANSPLANT PATIENTS: PRELIMINARY STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- COVID-19 vaccination response rate
研究概览
简要总结
The goal of this observational study is to evaluate the immune response after COVID-19 vaccination in Liver(LT) and Kidney(KT) transplant recipient. The main question it aims to answer are:
- the evaluation of the antibody response after complete vaccination
- the efficacy of prophylaxis with long-acting-antibody prophylaxis (LAAB)
All LT and KT patients during follow-up have been enrolled. anti-COVID-19 title was obtained by Electrochemiluminescence Immunoassay (ECLIA) Test(Elyx, Roche). In the case of antibody level <100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca). At three months, a follow-up was performed to assess any COVID-19 infection. At Six months another anti-COVID-19 title is obtained by ECLIA Test(Elyx, Roche) in LT and KT who undergo to LAAB.
详细描述
Liver(LT) and kidney(KT) transplant patients are at high risk of mortality from COVID-19(16-29%, 28%; respectively). Although transplant patients undergo a full vaccination course(3 doses), they are frequently low-responders and long-acting-antibody prophylaxis (LAAB) has been proposed. However, the efficacy of these strategies has not yet been demonstrated in LT and KT.
The goal of this observational study is to evaluate the immune response after COVID-19 vaccination in Liver(LT) and Kidney(KT) transplant recipient. The main question it aims to answer are:
- the evaluation of the antibody response after complete vaccination
- the efficacy of prophylaxis with long-acting-antibody prophylaxis (LAAB)
All LT and KT patients during follow-up have been enrolled. anti-COVID-19 title was obtained by Electrochemiluminescence Immunoassay (ECLIA) Test(Elyx, Roche). In the case of antibody level <100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca). At three months, a follow-up was performed to assess any COVID-19 infection. At Six months another anti-COVID-19 title is obtained by ECLIA Test(Elyx, Roche) in LT and KT who undergo to LAAB.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •KT and LT transplant patients in follow up in Tor Vergata University
- •Age >18 years
- •At least 3 month post transplantation
排除标准
- •pediatric recipients
- •Active covid infection at the time of the study
- •Pregnancy
- •Allergy to any ingredients included in the vaccine
- •Acute liver or kidney acute rejection proven by biopsy
- •Acute Febrile state with either leucopenia or leucocytosis
- •High dose of corticosteroid at study timing (pulse methyl prednisolone)
研究组 & 干预措施
Kidney and Liver Transplant
All Kidney and Liver Transplant recipients who are at follow-up in our institution will be enrolled. anti-COVID-19 title was obtained by ECLIA Test(Elyx, Roche). In the case of antibody level <100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca). At three months, a follow-up was performed to assess any COVID-19 infection.
干预措施: tixagevimab-cilgavimab(AZD7442, AstraZeneca) (Drug)
结局指标
主要结局
COVID-19 vaccination response rate
时间窗: time 0
The objective of our study is the evaluation of the antibody response after complete vaccination. The anti-COVID-19 title was obtained by ECLIA Test(Elyx, Roche).
Clinical efficacy of LAAB prophylaxis
时间窗: three months from LAAB prophilaxys
After COVID-19 title evaluation, in the case of antibody level \<100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca). At three months, a follow-up was performed to assess any COVID-19 infection.
次要结局
- Serological title at six months(Six months from LAAB prophylaxis)
研究者
Roberta Angelico
Lecturer in General Sugery PhD FEBS
University of Rome Tor Vergata