Understanding long-term cognitive effects of COVID-19 in Veterans
Immune-mediated Pathogenic Mechanisms of Neuro-PASC in Veterans
This study is trying to understand how COVID-19 affects the thinking and mental health of Veterans over time to help find better treatments for those struggling with these issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 2 sites (Portland, Oregon and 1 other locations) |
| Trial ID | NCT06932237 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the long-term neuropsychiatric and neurological effects of COVID-19, specifically focusing on Veterans who experience cognitive impairments and mental health symptoms post-infection. Researchers will conduct a longitudinal assessment of cognitive function and psychiatric symptoms while evaluating biomarkers related to inflammation and neuropsychiatric function. The study will integrate clinical findings with biological data to identify potential biomarkers and clinical endpoints that could inform future therapeutic interventions for neuro-PASC.
Who should consider this trial
Good fit: Ideal candidates for this study are Veterans who have had a confirmed SARS-CoV-2 infection and currently experience neuro-PASC symptoms.
Not a fit: Patients with pre-existing neurological disorders or mood disorders prior to their COVID-19 infection may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved understanding and treatment options for Veterans suffering from cognitive deficits and mental health issues following COVID-19.
How similar studies have performed: Other studies have shown promise in understanding the neuropsychiatric effects of COVID-19, but this specific approach focusing on Veterans and neuro-PASC is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: 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
Where this trial is running
Portland, Oregon and 1 other locations
- VA Portland Health Care System, Portland, OR — Portland, Oregon, United States (Recruiting)
- James H. Quillen VA Medical Center, Mountain Home, TN — Mountain Home, Tennessee, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Jennifer M Loftis, MA PhD — VA Portland Health Care System, Portland, OR
- Study coordinator: Jennifer M Loftis, MA PhD
- Email: Jennifer.Loftis2@va.gov
- Phone: (503) 220-8262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.