Long-term Effects of COVID-19

April 25, 2024 updated by: Young M. Erben, Mayo Clinic

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: Baseline, 9 months, 12 months, 24 months.
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
Time Frame: Baseline, 9 months, 12 months, 24 months.
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
Time Frame: Baseline, 9 months, 12 months, 24 months.
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
Time Frame: Baseline, 9 months, 12 months, 24 months.
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
Time Frame: Baseline, 9 months, 12 months, 24 months.
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
Time Frame: Baseline, 9 months, 12 months, 24 months.
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
Time Frame: Baseline, 9 months, 12 months, 24 months.
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
Time Frame: Baseline, 9 months, 12 months, 24 months.
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
Time Frame: Baseline, 9 months, 12 months, 24 months.
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
Time Frame: Baseline, 9 months, 12 months, 24 months.
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
Time Frame: Baseline, 9 months, 12 months, 24 months.
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
Time Frame: Baseline, 9 months, 12 months, 24 months.
Collect participants' self reported response from questionnaire: Montreal Cognitive Assessment
Baseline, 9 months, 12 months, 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Young Erben, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2022

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

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 (Estimated)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on (R)-1-(2-chlorophenyl)- N-[11C] ([11C] PK11195)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe