Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT06932237

Conditions

Neuro-PASC

Long COVID

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Neuro-PASC

Long COVID

Study ID

NCT06932237

Start date

Feb 20, 2025

Status verified date

Mar, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Fatigue Severity Scale (FSS) [ Time Frame: Baseline, 6-Month, 12-Month ]
  • Prospective and Retrospective Memory Questionnaire (PRMQ) [ Time Frame: Baseline, 6-Month, 12-Month ]
  • Spatial Working Memory (SWM) [ Time Frame: Baseline, 6-Months, 12-Months ]
  • Paired Associates Learning (PAL) [ Time Frame: Baseline, 6-Month, 12-Month ]
  • Stockings of Cambridge (SOC) [ Time Frame: Baseline, 6-Month, 12-Month ]
  • Delayed Matching Sample (DMS) [ Time Frame: Baseline, 6-Month, 12-Month ]
  • Rapid Visual Information Processing (RVP) [ Time Frame: Baseline, 6-Month, 12-Month ]
  • Apolipoprotein E (APOE) Genotyping [ Time Frame: Baseline, 6-Months, 12-Months ]
  • Long Covid Questionnaire [ Time Frame: Baseline ]
  • Delis-Kaplan Executive Functioning - Verbal Fluency (D-KEFS-VF) [ Time Frame: Baseline, 6-Months, 12-Months ]

Central Contacts and Locations

Central contacts

Jennifer M Loftis, MA PhD

(503) 220-8262Jennifer.Loftis2@va.gov

Emily R Sano, MA

(503) 220-8262emily.sano@va.gov

Locations

VA Portland Health Care System, Portland, OR

Recruiting

Portland, Oregon, United States, 97207-2964

Contacts

Jennifer M Loftis, MA PhD

503-220-8262Jennifer.Loftis2@va.gov

Emily R Sano, MA

(503) 220-8262emily.sano@va.gov

Principal Investigator:

Jennifer M Loftis, MA PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Keywords

  • COVID-19
  • Veterans
  • Cognitive
  • Post-Acute COVID-19 Syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-03-31.