Immune-mediated Pathogenic Mechanisms of Neuro-PASC in Veterans
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
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 design
Treatments tested in this trial
- Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsSponsors and collaborators
VA Office of Research and Development
Lead sponsor
James H. Quillen Department of Veterans Affairs Medical Center
Collaborator
Source ClinicalTrials.gov