COVID-19, SAR-CoV-2
Conditions
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.
Interventions
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.
DRUG2-(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.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Mayo Clinic
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed