Status:

RECRUITING

Immune-mediated Pathogenic Mechanisms of Neuro-PASC in Veterans

Lead Sponsor:

VA Office of Research and Development

Collaborating Sponsors:

James H. Quillen Department of Veterans Affairs Medical Center

Conditions:

Neuro-PASC

Long COVID

Eligibility:

All Genders

18-80 years

Brief 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 e...

Detailed Description

The goal of this research project is to identify the neuroinflammatory mechanisms contributing to post-COVID cognitive deficits and neuropsychiatric symptoms \[neuro-PASC (post-acute sequelae of SARS ...

Eligibility Criteria

Inclusion

  • 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

  • Exclusion criteria for all groups:
  • 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

Key Trial Info

Start Date :

February 20 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

March 31 2028

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT06932237

Start Date

February 20 2025

End Date

March 31 2028

Last Update

April 20 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

VA Portland Health Care System, Portland, OR

Portland, Oregon, United States, 97207-2964

2

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

Mountain Home, Tennessee, United States, 37684