Immune-mediated Pathogenic Mechanisms of Neuro-PASC in Veterans

ConditionsNeuro-PASC Long COVID

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-80

SponsorVA Office of Research and Development

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

Disqualifiers

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

Trial population

Veterans

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants

are grouped into 2 trial groups

Group A: Neuro-PASC

Group B: Neuro-PASC-imaging

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

Baseline, 6-Months, 12-Months

Paired Associates Learning (PAL)

Online cognitive assessment measuring visual memory and new learning.

Time frame

Baseline, 6-Month, 12-Month

Secondary outcomes

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.

Time frame

Baseline, 6-Month, 12-Month

Patient Health Questionnaire-9 (PHQ-9)

Self-report questionnaire objectifying and assessing degree of depression severity.

Time frame

Baseline, 6-Months, 12-Months

Generalized Anxiety Disorder-7 (GAD-7)

A self-reported questionnaire used to assess the severity of anxiety symptoms.

Time frame

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.

Time frame

Baseline, 6-Months, 12-Months

Other outcomes

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.

Time frame

Baseline, 12-Months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

James H. Quillen Department of Veterans Affairs Medical Center

Collaborator

Source ClinicalTrials.gov

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