Clinical trial NCT05220514: Long-term Effects of COVID-19
Official title: Mayo Clinic Health System-wide Neurological, Vascular and Neurovascular Events With SARS-CoV-2- Part II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
SAR-CoV-2
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2022-02-02
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: Baseline, 9 months, 12 months, 24 months.
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
timeFrame: Baseline, 9 months, 12 months, 24 months.
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
timeFrame: Baseline, 9 months, 12 months, 24 months.
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
timeFrame: Baseline, 9 months, 12 months, 24 months.
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
timeFrame: Baseline, 9 months, 12 months, 24 months.
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
timeFrame: Baseline, 9 months, 12 months, 24 months.
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
timeFrame: Baseline, 9 months, 12 months, 24 months.
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
timeFrame: Baseline, 9 months, 12 months, 24 months.
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
timeFrame: Baseline, 9 months, 12 months, 24 months.
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
timeFrame: Baseline, 9 months, 12 months, 24 months.
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
timeFrame: Baseline, 9 months, 12 months, 24 months.
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
timeFrame: Baseline, 9 months, 12 months, 24 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Young Erben, MD
role: PRINCIPAL_INVESTIGATOR
References: