Mapping Organ Health Following COVID-19 Disease Due to SARS-CoV-2 Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Perspectum
- 入组人数
- 693
- 试验地点
- 2
- 主要终点
- Characterise prevalence and severity of organ volume change and damage (heart, kidneys and liver)
研究概览
简要总结
A prospective, longitudinal, observational cohort study looking at patients following COVID-19 disease using multi-parametric magnetic resonance imaging (MRI) to assess the degree and prevalence of organ injury.
详细描述
To date, correctly, all of the Government's efforts have been dedicated to providing sufficient hospital space, and the appropriate equipment, for treating the most serious cases of COVID-19. Equally, enormous resource is being dedicated to developing technologies that determine who has the disease, and who has developed antibodies to it.
However, patients recovering from serious disease will also pose a huge, ongoing challenge. Not only are people with co-morbidities including underlying fatty liver disease, metabolic syndrome and diabetes at higher risk for complications with COVID-19; but patients discharged from hospital after severe COVID-19 are reported to have liver and kidney injuries, and impacts on pancreas and spleen. However, the extent of organ health/damage has not been mapped.
This is a prospective, longitudinal, observational cohort study looking at patients recovering from COVID-19 disease using multi-parametric magnetic resonance imaging (MRI) to assess the degree and prevalence of organ injury. This proposed study aims to measure the prevalence of organ volume changes and damage in lungs, heart, kidney, liver, pancreas, spleen as assessed by MRI among those having recovered, or recovering, from the SARS-CoV-2 infection - participants will have a final MRI scan at 12 months. Assessing the severity and sequelae of COVID-19 in patients is crucial to enable global planning for health-care needs. The study includes up to 3 visits for MRI scans and blood tests over a 12 month period. All participants will receive standard-of-care by their healthcare provider/s.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 years of age and older willing and able to give informed consent to participate in the study
- •Recent confirmed diagnosis of SARS-CoV-2 RNA via a polymerase chain reaction (PCR) assay (having been discharged 7 or more days from hospital).
排除标准
- •Symptoms of active respiratory viral infection:
- •high temperature (over 37.8C/100.04F)
- •cough (consistent for over an hour; 3 or more episodes in 24 hours)
- •The participant may not enter the study with any known contraindication to magnetic resonance imaging (including but not limited to pregnancy, a pacemaker or other metallic unfixed implanted device, metallic fragments, extensive tattoos, severe claustrophobia).
- •Any other cause, including a significant underlying disease or disorder which, in the opinion of the investigator, may put the participant at risk by participating in the study or limit the participant's ability to participate.
结局指标
主要结局
Characterise prevalence and severity of organ volume change and damage (heart, kidneys and liver)
时间窗: 12 Months
In patients recovering from COVID-19 disease: Characterise using summary statistics the prevalence and severity of organ volume change and damage to heart, kidneys and liver
次要结局
- Characterise prevalence and severity of organ volume change and damage (lung, pancreas and spleen)(12 Months)
- Change from Baseline in liver-specific biomarkers: volume, iron corrected T1(cT1), fat content and T2star(6 Months)
- Change from Baseline in organ-specific biomarkers characterising organ volume change in the heart and spleen along with organ volume and damage in the kidney, liver and pancreas assessed by volume, iron corrected T1 (cT1) and fat infiltration(12 Months)
- Change in patient reported outcome measured by the Dyspnea-12 questionnaire(12 Months)
- Change in patient reported outcome measured by the Saint George's Respiratory questionnaire (SGRQ)(12 Months)
- Change in patient reported outcome measured by the EQ-5D-5L questionnaire(12 Months)
- Degree of change in liver MR-derived biomarkers(12 Months)