Humoral Immunity Against SARS-CoV-2 in Liver Transplanted Patients After COVID-19 in Comparison With Immunocompetent Patients
Development and Persistence of Humoral Immunity Against SARS-CoV-2 in Liver Transplanted Patients in Comparison With Immunocompetent Patients
研究概览
详细说明
The liver transplant (HT) recipient population is more susceptible to infections than the general population. Few data are available regarding the incidence and clinical course of SARS-CoV-2 infection in this population, initially considered to be "high risk" regarding a possible higher incidence and severity of infection in these patients.
A prospective cohort of liver transplant recipient patients diagnosed with SARS-CoV-2 infection (Clinical Trials.gov Protocol Record HCB / 2020/0384) has been developed from SETH (Spanish Society for Liver Transplantation). This study aims to analyze the incidence and establish the clinical evolution of the infection in these patients. Initial data from the cohort, which includes 111 incidental cases diagnosed as of April 7, show a higher standardized incidence than the general population, but not higher mortality (data being published).
The chronic immunosuppression in t solid organ transplant patients could play a double role with respect to SARS-Cov-2 infection: on the one hand, it may condition a greater susceptibility and initial aggressiveness, in relation to itself viral effect, and in the other hand, it could protect by reducing the immune response that triggers the pulmonary and systemic inflammatory process.
After the initial Covid-19 outbreak, both in the general population and in immunosuppressed patients, the rate of specific IgM and IgG seroconversion against this coronavirus, and its protective capacity against reactivations or reinfections, are unknown. Therefore, it is a challenge for health organizations to identify the immune response in the population and to characterize its degree of protection, to adopt early measures to lessen the consequences of possible epidemic waves in the coming months.
Continuing with the prospective study of the cohort of liver transplant patients diagnosed with Covid-19 (SETH-Covid-19), already defined and composed of 91 living patients, the humoral immune response and its evolution in the first 12 months after initial infection. The cohort will incorporate the new incidental cases; A comparative study will be carried out with a contemporary cohort of non-immunosuppressed patients, controlled for age, gender and severity of the initial disease.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Madrid、西班牙、28009
- 尚未招聘
- Victor Fernández Alonso
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接触:
- Victor Fernandez Alonso
- 电话号码:+34915866687
- 邮箱:victor.fernandez@iisgm.com
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Madrid、西班牙、28009
- 招聘中
- Victor Fernández Alonso
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接触:
- Victor Fernández, Nurse
- 电话号码:+34915866687
- 邮箱:victor.fernandez@iisgm.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
Patients recovered of covid 19 Informed Consent
Exclusion Criteria:
Chemotherapy on going Concomitant Autoimmune diseases
学习计划
研究是如何设计的?
设计细节
- 观测模型:病例对照
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Liver transplant patient after having Covid19
Adult Liver transplant patient who had survived to Covid19 in the first wave of the disease in Spain (disease until june 30th), in all the liver Transplant Units in Spain (24).
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Report of clinical data
其他名称:
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No immunosuppressed patient with previous Covid19
Not immunosuppressed patient who had survived to Covid19 in the first wave of the disease.
These patient have been diagnosed and treated in the Hospital Gregorio Marañón (Madrid), before 30th June
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Report of clinical data
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of IgG against SARS-CoV-2
大体时间:one year
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Proportion, Rate
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one year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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titration and evolution of humoral response (IgG) along first 12 months after having Covid-19
大体时间:12 months
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Titer
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12 months
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Reinfection of Covid-19
大体时间:one year
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Categoric Yes/Not
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one year
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mortality
大体时间:12 months after Covid-19
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Rate
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12 months after Covid-19
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合作者和调查者
调查人员
- 首席研究员:Magdalena Salcedo, MD PhD、Liver Transplantation Unit
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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