Genetic Mechanisms Underlying SARS-CoV-2 Infection and the Impact of COVID-19 on Cognitive Function
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Genetic variants with vs without COVID-19
Study Overview
Brief Summary
There is a considerable variation in the disease behavior in terms of contracting the infection, manifesting none to a range of symptoms and severity of the infection among individuals exposed to or infected with SARS-CoV-2 virus, the causative organism of COVID-19. Although the respiratory system appears to be the primary target of this virus infection, emerging evidences suggests involvement of extra-pulmonary organs including central nervous system. We aim to compare the genetic profile of individuals with vs without COVID-19 after being exposed to infected cases. Additionally, we will assess the cognitive function in covid-19 positive cases with vs. without neurological symptoms at the time of infection and 1-month follow-up using the Montreal Cognitive Assessment (MoCA) questionnaire.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female over 18 years of age at the time of enrollment
- •Have symptoms of COVID-19 (with or without hospitalization) or contact history
- •Willing to undergo nasopharyngeal swab test for viral-RNA at baseline (in non-hospitalized cases) and the MoCA survey at baseline and 1-month follow-up
Exclusion Criteria
- •Unwilling to provide informed consent
- •MoCA score ≤17 at baseline
- •Patients with clinical diagnosis of dementia
- •Impaired consciousness
Outcomes
Primary Outcomes
Genetic variants with vs without COVID-19
Time Frame: 1 day
Evaluate variants in the following known COVID-associated genes, ACE2R, IFITM, HLA-B 46, HLA-B 15, Toll Like Receptor and IFN-1, LIST, Perforin and mutations in Chromosome 3p21.31 along with novel genetic variants.
Cognitive function at baseline
Time Frame: 1 day
Assess the cognitive status at baseline using MoCA survey in patients with vs without neurological symptoms
Secondary Outcomes
- Change in cognitive function at 1 month(1 month)
- Genetic analysis(1 day)
Investigators
Andrea Natale
Executive Medical Director
Texas Cardiac Arrhythmia Research Foundation