Long-term Effects of COVID-19

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

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 Overview

• Status: Completed
• Conditions: COVID-19; SAR-CoV-2
• Intervention / Treatment: 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)

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A sample size of 100 patients hospitalized for COVID-19 with a subset of control patients hospitalized and receiving intensive care for diagnosis other than COVID-19 or an acute neurological disease.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Young Erben, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Antineoplastic Agents; PK 11195
• Other Study ID Numbers: 21-008855; R35NS097273 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No