Long-term Effects of COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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Mayo Clinic Health System-wide Neurological, Vascular and Neurovascular Events With SARS-CoV-2- Part II

Conditions
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COVID-19, SAR-CoV-2

Intervention / Treatment
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* Drug: (R)-1-(2-chlorophenyl)- N-[11C] ([11C] PK11195)
* Drug: 2-(4-[11C]methylamino phenyl)-6-hydroxybenzothiazole (11C]6-OH-BTA-1 or [11C]PIB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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-19. 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-COVID-19 Diagnosis Control Group<br>Subjects hospitalized and receiving intensive care for diagnosis of an acute neurological disease other than COVID-19 | Drug: (R)-1-(2-chlorophenyl)- N-[11C] ([11C] PK11195)<br>* Radiotracer used during the PET-MR scan of the study to identify signs of disease. Used in studies related to Alzheimer's disease. Only FDA approved for investigational use.<br>Drug: 2-(4-[11C]methylamino phenyl)-6-hydroxybenzothiazole (11C]6-OH-BTA-1 or [11C]PIB)<br>* Radiotracer used during the PET-MR scan of the study to identify signs of disease. Used in studies related to Alzheimer's disease. Only FDA approved for investigational use.<br>|
| COVID-19 Diagnosis Case Group<br>Subjects previously hospitalized at Mayo Clinic Hospital for treatment of PCR test confirmed COVID-19 | Drug: (R)-1-(2-chlorophenyl)- N-[11C] ([11C] PK11195)<br>* Radiotracer used during the PET-MR scan of the study to identify signs of disease. Used in studies related to Alzheimer's disease. Only FDA approved for investigational use.<br>Drug: 2-(4-[11C]methylamino phenyl)-6-hydroxybenzothiazole (11C]6-OH-BTA-1 or [11C]PIB)<br>* Radiotracer used during the PET-MR scan of the study to identify signs of disease. Used in studies related to Alzheimer's disease. Only FDA approved for investigational use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Collect participants' self reported response from questionnaire: Post-Covid Functional Status. | Baseline, 9 months, 12 months, 24 months. | 
| 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 | Collect participants' self reported response from questionnaire: Questionnaire for Verifying stroke-free Status. | Baseline, 9 months, 12 months, 24 months. | 
| 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 | Collect participants' self reported response from questionnaire: Patient Health Questionnaire. | Baseline, 9 months, 12 months, 24 months. | 
| 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 | Collect participants' self reported response from questionnaire: Six-Item Screener. | Baseline, 9 months, 12 months, 24 months. | 
| 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 | Collect participants' self reported response from questionnaire: Modified Rankin Scale. | Baseline, 9 months, 12 months, 24 months. | 
| 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 | Collect participants' self reported response from questionnaire: Clinical Dementia Rating. | Baseline, 9 months, 12 months, 24 months. | 
| 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 | Collect participants' self reported response from questionnaire: National Institutes of Health Stroke Scale. | Baseline, 9 months, 12 months, 24 months. | 
| 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 | Collect participants' self reported response from questionnaire: Neuropsychiatric Inventory Questionnaire. | Baseline, 9 months, 12 months, 24 months. | 
| 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 | Collect participants' self reported response from questionnaire: Epworth Sleepiness Scale. | Baseline, 9 months, 12 months, 24 months. | 
| 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 | Collect participants' self reported response from questionnaire: National Alzheimer's Coordinating Center Unified Data Set | Baseline, 9 months, 12 months, 24 months. | 
| 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 | Collect participants' self reported response from questionnaire: Unified Parkinson Disease Rating Scale III. | Baseline, 9 months, 12 months, 24 months. | 
| 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 | Collect participants' self reported response from questionnaire: Montreal Cognitive Assessment | Baseline, 9 months, 12 months, 24 months. |