Long-term Effects of COVID-19
Study Details
Study Description
Brief Summary
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Non-COVID-19 Diagnosis Control Group 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)
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.
Drug: 2-(4-[11C]methylamino phenyl)-6-hydroxybenzothiazole (11C]6-OH-BTA-1 or [11C]PIB)
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.
|
| COVID-19 Diagnosis Case Group Subjects previously hospitalized at Mayo Clinic Hospital for treatment of PCR test confirmed COVID-19 |
Drug: (R)-1-(2-chlorophenyl)- N-[11C] ([11C] PK11195)
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.
Drug: 2-(4-[11C]methylamino phenyl)-6-hydroxybenzothiazole (11C]6-OH-BTA-1 or [11C]PIB)
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.
|
Outcome Measures
Primary Outcome Measures
- 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 [Baseline, 9 months, 12 months, 24 months.]
Collect participants' self reported response from questionnaire: Post-Covid Functional Status.
- 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 [Baseline, 9 months, 12 months, 24 months.]
Collect participants' self reported response from questionnaire: Questionnaire for Verifying stroke-free Status.
- 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 [Baseline, 9 months, 12 months, 24 months.]
Collect participants' self reported response from questionnaire: Patient Health Questionnaire.
- 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 [Baseline, 9 months, 12 months, 24 months.]
Collect participants' self reported response from questionnaire: Six-Item Screener.
- 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 [Baseline, 9 months, 12 months, 24 months.]
Collect participants' self reported response from questionnaire: Modified Rankin Scale.
- 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 [Baseline, 9 months, 12 months, 24 months.]
Collect participants' self reported response from questionnaire: Clinical Dementia Rating.
- 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 [Baseline, 9 months, 12 months, 24 months.]
Collect participants' self reported response from questionnaire: National Institutes of Health Stroke Scale.
- 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 [Baseline, 9 months, 12 months, 24 months.]
Collect participants' self reported response from questionnaire: Neuropsychiatric Inventory Questionnaire.
- 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 [Baseline, 9 months, 12 months, 24 months.]
Collect participants' self reported response from questionnaire: Epworth Sleepiness Scale.
- 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 [Baseline, 9 months, 12 months, 24 months.]
Collect participants' self reported response from questionnaire: National Alzheimer's Coordinating Center Unified Data Set
- 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 [Baseline, 9 months, 12 months, 24 months.]
Collect participants' self reported response from questionnaire: Unified Parkinson Disease Rating Scale III.
- 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 [Baseline, 9 months, 12 months, 24 months.]
Collect participants' self reported response from questionnaire: Montreal Cognitive Assessment
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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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.
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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.
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Women of childbearing age, between the ages of 18 to 55, must complete a negative pregnancy test.
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Minority individuals over the age of 18 years will be eligible to enroll.
Exclusion Criteria:
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Males and females, under the age of 18 years.
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Participants with PET/MRI non-compatible devices.
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Claustrophobia.
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Allergies to study related procedures.
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Pregnant , incarcerated, or institutionalized subjects will not be included in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic Florida | Jacksonville | Florida | United States | 32224 |
Sponsors and Collaborators
- Mayo Clinic
- National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
- Principal Investigator: Young Erben, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 21-008855
- R35NS097273