Multicentric Study of Coronavirus Disease 2019 (COVID-2019) in Solid Organ Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 488
- 试验地点
- 1
- 主要终点
- Incidence of coronavirus infection in Solid Organ Transplant Recipients
研究概览
简要总结
The overall purpose of this project is to better understand the incidence, risk factors, etiology, clinical manifestations and outcome of tCOVID19 in solid organ transplant recipients. The results obtained will allow us to gain insight on the need of antiviral treatment, on the strategy for complications surveillance, on how to adjust the immunosuppressant therapy and on the level of care in which each patient should be treated. In order to attain the objectives previously described we will develop a multicenter prospective study of consecutive cases of COVID-19 among solid organ transplant recipients.
详细描述
There will be a clinical follow-up of the patients included in this study to observe possible complications and survival rate. Data collected form this study will be evaluated with a descriptive statistical analysis of the cohort consisting of analysis of the risk factors of COVID-19. Subsequently a multivaried logistic regression analysis will be performed in which the factors selected from the analysis and those clinically relevant.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 16 years with a solid organ transplant diagnosed of COVID-
- •NOTE: A confirmed case of infection, is defined by a clinical syndrome that is compatible to that of an respiratory infection (fever, cough and/or dyspnea) and the presence of a positive microbiological result.
排除标准
- •Absence of informed consent after giving the information regarding the study.
结局指标
主要结局
Incidence of coronavirus infection in Solid Organ Transplant Recipients
时间窗: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus
Number of Solid Organ Transplant Recipients positive to coronavirus
Clinical manifestations of coronavirus infection in Solid Organ Transplant Recipients
时间窗: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus
Number of participants who present clinical symptoms possibly related to coronavirus infection in Solid Organ Transplant Recipients
Presence of other risk factors
时间窗: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus
Gathering possible risk factors in coronavirus infection in Solid Organ Transplant
Establish the frequency and type of complications related to the net state of the patient immunosuppression
时间窗: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus
Establish the frequency and type of complications related to the net state of the patient immunosuppression
次要结局
- Laboratory characteristics(At inclusion and at 28 days of follow up)
- Determination of coronavirus viral load(At inclusion at 14 days and at 28 days)
- Microbiological testing(At inclusion at 14 days and at 28 days)
- Frequency of co-infections(From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus)
- Mortality(From baseline at the time of signature of informed consent form up to study completion at 3 months folllow-up)