Immune-mediated Pathogenic Mechanisms of Neuro-PASC in Veterans

Part of paid clinical trials in Portland, Oregon.

Sponsor
VA Office of Research and Development
Study ID
NCT06932237
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Study Details

Mental health symptoms, including cognitive impairment ("brain fog"), following COVID-19 are of great concern to Veterans. This 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.

Key Dates

Start date
Feb 20, 2025
Status verified
Mar 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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.

Primary Outcome Measure

Fatigue Severity Scale (FSS) [ Time Frame: Baseline, 6-Month, 12-Month ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
VA Portland Health Care System, Portland, ORPortlandOregon97207-2964
Jennifer M Loftis, MA PhD
503-220-8262
Emily R Sano, MA
(503) 220-8262
Jennifer M Loftis, MA PhD (PRINCIPAL_INVESTIGATOR)
James H. Quillen VA Medical Center, Mountain Home, TNMountain HomeTennessee37684
Jonathan Moorman, MD
423-439-8065

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