RecruitingNCT06932237

Immune-mediated Pathogenic Mechanisms of Neuro-PASC in Veterans


Sponsor

VA Office of Research and Development

Enrollment

200 participants

Start Date

Feb 20, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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

Exclusion Criteria4

  • diagnosed with dementia, traumatic brain injury, a neurological syndrome (e.g. Parkinson disease, Alzheimer disease), or other progressive cognitive disorder before SARS-CoV-2 infection
  • diagnosed with a mood or psychotic disorder before SARS-CoV-2 infection
  • history of fibromyalgia or chronic fatigue syndrome prior to SARS-CoV-2 infection
  • unstable medical conditions or active uncontrolled autoimmune or inflammatory conditions

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Locations(2)

VA Portland Health Care System, Portland, OR

Portland, Oregon, United States

James H. Quillen VA Medical Center, Mountain Home, TN

Mountain Home, Tennessee, United States

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NCT06932237


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