COVID-19NCT05220514
Long-term Effects of COVID-19
An observational study of COVID-19 and SAR-CoV-2, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- (R)-1-(2-chlorophenyl)- N-[11C] ([11C] PK11195) and 2-(4-[11C]methylamino phenyl)-6-hydroxybenzothiazole (11C]6-OH-BTA-1 or [11C]PIB)
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2022to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- (R)-1-(2-chlorophenyl)- N-[11C] ([11C] PK11195), 2-(4-[11C]methylamino phenyl)-6-hydroxybenzothiazole (11C]6-OH-BTA-1 or [11C]PIB)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(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.
| Study group | Role | What they receive |
|---|---|---|
| Non-COVID-19 Diagnosis Control Group | Subjects hospitalized and receiving intensive care for diagnosis of an acute neurological disease other than COVID-19 Receives: 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 Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline, 9 months, 12 months, 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start19 Jan 2022
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young M. Erben, Mayo Clinic
- Investigators
- Young Erben, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220514
- Sponsor's protocol ID
- 21-008855
- Other IDs
- R35NS097273
- Status last verified
- Feb 2025
- First submitted
- 10 Jan 2022
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mayo Clinic Health System-wide Neurological, Vascular and Neurovascular Events With SARS-CoV-2- Part II
- ClinicalTrials.gov ID
- NCT05220514
- Acronym / sponsor ID
- 21-008855
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-COVID-19 Diagnosis Control Group | – | 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)Subjects hospitalized and receiving intensive care for diagnosis of an acute neurological disease other than COVID-19 |
| COVID-19 Diagnosis Case Group | – | 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)Subjects previously hospitalized at Mayo Clinic Hospital for treatment of PCR test confirmed COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (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 | COVID-19 Diagnosis Case Group, Non-COVID-19 Diagnosis Control Group |
| 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. | Drug | COVID-19 Diagnosis Case Group, Non-COVID-19 Diagnosis Control Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Erben, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SAR-CoV-2, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.