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OpenTrials
Completed

NCT Number: NCT05220514

Long-term Effects of COVID-19

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SAR-CoV-2 Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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)

Drug

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 2, 2022
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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