Long-term Effects of COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05220514
• Other study ID #: 21-008855
• Secondary ID: R35NS097273
• Status: Recruiting
• Start date: January 19, 2022
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Jada McCullough
• Phone: (904) 953-4003
• Email: McCullough.Jada[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.