Long-term Effects of COVID-19

NCT ID: NCT05220514

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-19

Study Completion Date

2024-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 SAR-CoV-2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non-COVID-19 Diagnosis Control Group

Subjects hospitalized and receiving intensive care for diagnosis of an acute neurological disease other than COVID-19

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

Intervention Type 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)

Intervention Type 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 Group

Subjects previously hospitalized at Mayo Clinic Hospital for treatment of PCR test confirmed COVID-19

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

Intervention Type 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)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

(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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Young M. Erben

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Young Erben, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R35NS097273

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-008855

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CSL324 in COVID-19
NCT04519424 WITHDRAWN PHASE2
Pyridostigmine in Severe SARS-CoV-2 Infection
NCT04343963 UNKNOWN PHASE2/PHASE3