NCT05220514

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

January 19, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

2.9 years

First QC Date

January 10, 2022

Last Update Submit

February 5, 2025

Conditions

COVID-19SAR-CoV-2

Outcome Measures

Primary Outcomes (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

    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.

Study Arms (2)

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)Drug: 2-(4-[11C]methylamino phenyl)-6-hydroxybenzothiazole (11C]6-OH-BTA-1 or [11C]PIB)

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)Drug: 2-(4-[11C]methylamino phenyl)-6-hydroxybenzothiazole (11C]6-OH-BTA-1 or [11C]PIB)

Interventions

(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.

COVID-19 Diagnosis Case GroupNon-COVID-19 Diagnosis Control Group
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.

COVID-19 Diagnosis Case GroupNon-COVID-19 Diagnosis Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

PK 111952-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Young Erben, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2022

First Posted

February 2, 2022

Study Start

January 19, 2022

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

February 7, 2025

Record last verified: 2025-02

Locations

US(1)