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| ID | Type | Description | Link |
|---|---|---|---|
| I01CX002668 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| James H. Quillen Department of Veterans Affairs Medical Center | UNKNOWN |
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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.
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 CoV-2 infection)]. This collaborative research effort will also characterize new or worsened mental health symptoms and genetic and environmental risk factors for the incidence and severity of post-COVID neuropsychiatric impairments. Aim 1 will monitor and evaluate cognitive injury and neuro-PASC symptoms and determine whether APOE genotype modulates severity of the cognitive injury and neuro-PASC symptoms. Cognitive functioning will be evaluated over time using neuropsychological measures assessing domains most relevant to PASC: learning and memory, attention/concentration, social cognition/emotions, and executive function; assessments will include standardized measures. Mental health symptoms known to be induced and exacerbated by inflammation and potentially developing as a result of COVID-19 will also be evaluated. APOE genotyping will be determined based on saliva or blood samples. Aim 2 will identify immune-related biomarkers associated with cognitive injury and neuro-PASC symptoms. Blood (plasma and cells) will be used to identify biomarkers associated with PASC progression or severity, promotion of brain repair, attenuation of symptoms. Plasma will be used for Olink proteomics, followed by confirmatory multiplex assays or enzyme-linked immunosorbent assays (ELISAs). The investigators will assess relationships among biomarkers and cognitive injury and neuro-PASC symptoms across APOE genotypes and contribute data and samples to the repository managed by Dr. Moorman (Co-Investigator). Aim 3 (exploratory aim; conducted in Portland only) will assess neuroimaging correlates of cognitive injury and neuro-PASC symptoms. Neuroimaging evaluations (i.e., whole brain voxel-based morphometry, diffusion-tensor imaging, resting-state connectivity, and task-based assessments) will be conducted at baseline and at 12 months to correlate magnetic resonance imaging (MRI) measures with symptoms of long COVID (e.g., cognitive impairment and neuropsychiatric symptoms) across APOE genotypes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Severity Scale (FSS) | A nine-item self-report questionnaire designed to assess fatigue as a symptom of a variety of different chronic conditions and disorders. | Baseline, 6-Month, 12-Month |
| Prospective and Retrospective Memory Questionnaire (PRMQ) | A self-report measure of everyday memory, assessing prospective (the ability to remember to do things in the future) and retrospective memory. | Baseline, 6-Month, 12-Month |
| Spatial Working Memory (SWM) | Online cognitive assessment requiring retention and manipulation of visuospatial information; measures executive functioning (i.e., strategy) and working memory. | Baseline, 6-Months, 12-Months |
| Paired Associates Learning (PAL) | Online cognitive assessment measuring visual memory and new learning. | Baseline, 6-Month, 12-Month |
| Stockings of Cambridge (SOC) | Online cognitive assessment measuring problem-solving strategies. | Baseline, 6-Month, 12-Month |
| Delayed Matching Sample (DMS) | Online cognitive assessment measuring visual matching ability and short-term visual recognition memory. | Baseline, 6-Month, 12-Month |
| Rapid Visual Information Processing (RVP) | Online cognitive assessment measuring sustained attention. |
| Measure | Description | Time Frame |
|---|---|---|
| Posttraumatic Stress Disorder Checklist - Civilian Version (PCL-C) | A standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. | Baseline, 6-Month, 12-Month |
| Patient Health Questionnaire-9 (PHQ-9) |
| Measure | Description | Time Frame |
|---|---|---|
| Neuroimaging | To detect pathological and restorative changes in the brain of COVID-19 survivors, neuroimaging evaluations will correlate magnetic resonance imaging (MRI) measures with symptoms of neuro-PASC. | Baseline, 12-Months |
Inclusion Criteria:
Eligible participants will:
Additionally, participants enrolled as part of the neuro-PASC group must also:
Exclusion Criteria:
Exclusion criteria for all groups:
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Veterans
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer M Loftis, MA PhD | Contact | (503) 220-8262 | 57155 | Jennifer.Loftis2@va.gov |
| Emily R Sano, MA | Contact | (503) 220-8262 | 58290 | emily.sano@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer M Loftis, MA PhD | VA Portland Health Care System, Portland, OR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Portland Health Care System, Portland, OR | Recruiting | Portland | Oregon | 97207-2964 | United States |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Blood and saliva samples
| Baseline, 6-Month, 12-Month |
| Apolipoprotein E (APOE) Genotyping | A genetic test that determines a person's inherited variations in the APOE gene. This gene plays a role in cholesterol metabolism and brain health. Blood and saliva samples will be used. | Baseline, 6-Months, 12-Months |
| Long Covid Questionnaire | Self-report measure that assesses the continued presence of Long-COVID symptomology. | Baseline |
| Delis-Kaplan Executive Functioning - Verbal Fluency (D-KEFS-VF) | Neuropsychological assessment measure of verbal behavioral productivity and cognitive flexibility. | Baseline, 6-Months, 12-Months |
Self-report questionnaire objectifying and assessing degree of depression severity.
| Baseline, 6-Months, 12-Months |
| Generalized Anxiety Disorder-7 (GAD-7) | A self-reported questionnaire used to assess the severity of anxiety symptoms. | Baseline, 6-Month, 12-Month |
| Biomarkers | Obtained from collected blood samples and saliva, biomarkers (including viral variants, genetic susceptibility, inflammatory markers, diagnostic markers, etc.) associated with specific symptoms of post-COVID conditions will be identified. | Baseline, 6-Months, 12-Months |
| James H. Quillen VA Medical Center, Mountain Home, TN | Not yet recruiting | Mountain Home | Tennessee | 37684 | United States |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |