Lung Structure-Function In SurVivors of Mild and SEvere COVID-19 Infection: 129Xe MRI For Rapid Evaluation and NExt-wave Healthcare Planning
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Primary
研究概览
简要总结
In this study the Investigators aim to deploy UTE and HP 129Xe MRI for structural and functional evaluation of persistent lung abnormalities in COVID-19 survivors.
详细描述
What is COVID-19? The ongoing Coronavirus Disease 2019 (COVID-19) pandemic is caused when an individual is infected with the SARS-CoV-2 virus. This infection can result in pneumonia involving the small airways and alveoli (the tiny air sacs at the end of the airways that help oxygen get into the blood). COVID-19 can cause damage to the lungs, making it hard to breathe without medical help. To understand what is happening to a patient's lungs, doctors may use imaging tests such as chest x-rays or CT Scans (computed tomography). However, these types of tests may not tell the Investigators the whole story.
What is the purpose of the study? Led by The Hospital for Sick Children (SickKids), this study is being done to determine if MRI (magnetic resonance imaging) scans can tell the Investigators more about the lungs of people who had COVID-19. The Investigators will use a special type of MRI where participants breathe in a special gas (hyperpolarized xenon-129) before they have the MRI. This gas will help the Investigators to see' the lungs. The advantage of MRI scans is that there is no radiation involved in these types of images.
What is involved? In this study, participants will have an MRI of their lungs. The Investigators will examine these MRI scans to see if the Investigators can identify any changes in the structure or the function of the lung. If the Investigators do find any changes, they will see how these changes relate to other tests that have been conducted or other parts of the clinical story.
The participants will be asked to come to SickKids for 3 study visits. A fourth visit will be conducted via telephone. These visits will span over 3 years. Each study visit will take about 4 hours. If the participant is unable to attend one of the in-person visits, they will be given the option for a phone/virtual visit instead.
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
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent provided
- •Aged 12-70 years old
- •Meets MRI screening criteria
- •Diagnosed with COVID19, documented by positive COVID19 test (Nasopharyngeal swab or saliva swab) and are within 3 months post recovery*.
- •Recovery from COVID19 is defined as asymptomatic for at least 2 weeks prior to study visit 1 and screen negative based on SickKids guidelines.
排除标准
- •Pregnant or lactating*
- •A cold or flu within the last 2 weeks
研究组 & 干预措施
Single arm
Those participants who have experienced a documented case (documented by positive COVID19 test and/or clinical history) mild or severe COVID19 infection including those with symptoms and those who were hospitalized with COVID19 infection, all of whom are within 3 months post recovery
干预措施: 129Xenon gas (Drug)
结局指标
主要结局
Primary
时间窗: 4 years
Determine if 129Xenon MRI can detect abnormalities in COVID19 survivors 3 months, 6 months, 1 year and 2 years post infection.
次要结局
- Secondary 2A (i)(3.5 years)
- Secondary 2A (iii)(3.5 years)
- Secondary 2C(3.5 years)
- Secondary 2D(3.5 years)
- Secondary 2A (ii)(3.5 years)
- Secondary 2B(3.5years)
研究者
Giles Santyr
Senior Scientist
The Hospital for Sick Children