Mayo Clinic Health System-wide Neurological, Vascular and Neurovascular Events With SARS-CoV-2- Part II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Change in neurological, cognitive, and functional trajectories in participants who are status post hospitalization for COVID-19 and participants receiving intensive care for diagnosis other than COVID-19
研究概览
简要总结
The purpose of this study is to measure, monitor, and analyze long term effects of SARS-CoV-2. The main purpose is to assess the post-hospitalization outcomes of patients who were diagnosed with SAR-CoV-2 by comparing to patients who were hospitalized with an acute neurological disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Control Participants: Males and females over the age of 18 years hospitalized and receiving intensive care for diagnosis's other than COVID-19 or an acute neurological disease and who were not diagnosed (clinically or with PCR testing) with COVID-
- •Case Participants: Males and females over the age of 18 years who had been hospitalized at Mayo Clinic Hospital for treatment of COVID-19 confirmed by PCR test.
- •We acknowledge that some participants may be unable to consent due to underlying medical conditions; an eligible proxy may provide the informed consent and provide a signature on the designated line.
- •Women of childbearing age, between the ages of 18 to 55, must complete a negative pregnancy test.
- •Minority individuals over the age of 18 years will be eligible to enroll.
排除标准
- •Males and females, under the age of 18 years.
- •Participants with PET/MRI non-compatible devices.
- •Claustrophobia.
- •Allergies to study related procedures.
- •Pregnant , incarcerated, or institutionalized subjects will not be included in the study.
研究组 & 干预措施
Non-COVID-19 Diagnosis Control Group
Subjects hospitalized and receiving intensive care for diagnosis of an acute neurological disease other than COVID-19
干预措施: (R)-1-(2-chlorophenyl)- N-[11C] ([11C] PK11195) (Drug)
Non-COVID-19 Diagnosis Control Group
Subjects hospitalized and receiving intensive care for diagnosis of an acute neurological disease other than COVID-19
干预措施: 2-(4-[11C]methylamino phenyl)-6-hydroxybenzothiazole (11C]6-OH-BTA-1 or [11C]PIB) (Drug)
COVID-19 Diagnosis Case Group
Subjects previously hospitalized at Mayo Clinic Hospital for treatment of PCR test confirmed COVID-19
干预措施: (R)-1-(2-chlorophenyl)- N-[11C] ([11C] PK11195) (Drug)
COVID-19 Diagnosis Case Group
Subjects previously hospitalized at Mayo Clinic Hospital for treatment of PCR test confirmed COVID-19
干预措施: 2-(4-[11C]methylamino phenyl)-6-hydroxybenzothiazole (11C]6-OH-BTA-1 or [11C]PIB) (Drug)
结局指标
主要结局
Change in neurological, cognitive, and functional trajectories in participants who are status post hospitalization for COVID-19 and participants receiving intensive care for diagnosis other than COVID-19
时间窗: Baseline, 9 months, 12 months, 24 months.
Collect participants' self reported response from questionnaire: Montreal Cognitive Assessment
次要结局
未报告次要终点
研究者
Young M. Erben
Principal Investigator
Mayo Clinic