Immune-mediated Pathogenic Mechanisms of Neuro-PASC in Veterans

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
SUMMARY

Mental health symptoms, including cognitive impairment (brain fog), following COVID-19 are of great concern to Veterans. The investigators' research seeks to advance understanding of the long-term effects of COVID-19 on neuropsychiatric and neurological functions, identifying clinically relevant biomarkers and directions for developing and testing therapeutic interventions. To accomplish these objectives the investigators are conducting a longitudinal study at two VA medical centers to: 1) assess and monitor cognitive function and psychiatric symptoms in Veterans post-COVID; 2) evaluate biomarkers of inflammation and signaling pathways associated with viral infection and neuropsychiatric function; and 3) integrate neuropsychiatric and neurological findings with biological data to identify biomarkers and clinical endpoints associated with disease progression or severity, as well as those for promoting brain repair and attenuating those symptoms.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ Eligible participants will:

• have a history of SARS-CoV-2 infection 4 weeks prior to enrollment, defined as a positive PCR or home antigen test

• be able to give informed consent as determined by brief cognitive exam and evaluation of understanding of the risks, benefits, and voluntary nature of the study

⁃ Additionally, participants enrolled as part of the neuro-PASC group must also:

• currently experience neuro-PASC symptoms, not present prior to infection, as confirmed by the Long COVID-19 Symptom Assessment scale, a self-report measure that consists of 46 common COVID-19 sequela symptoms

Locations
United States
Oregon
VA Portland Health Care System, Portland, OR
RECRUITING
Portland
Tennessee
James H. Quillen VA Medical Center, Mountain Home, TN
NOT_YET_RECRUITING
Mountain Home
Contact Information
Primary
Jennifer M Loftis, MA PhD
Jennifer.Loftis2@va.gov
503-220-8262
Backup
Emily R Sano, MA
emily.sano@va.gov
(503) 220-8262
Time Frame
Start Date: 2025-02-20
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 200
Treatments
Neuro-PASC
All participants enrolled in the study will attend 4 study visits: 1) Screening, 2) Baseline, 3) 6-Month Follow-up, and 4) 12-Month Follow-up. At the Baseline, 6-Month, and 12-Month follow-up, participants will complete an online neuropsychological assessment, questionnaires, blood draw, and saliva collection
Neuro-PASC-imaging
A subset (60) of Portland VA only participants will be provided with the opportunity to complete an MRI visit at baseline and the 12-month follow-up.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development
Collaborators: James H. Quillen Department of Veterans Affairs Medical Center

This content was sourced from clinicaltrials.gov

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