Genetic Mechanisms Underlying SARS-CoV-2 Infection and the Impact of COVID-19 on Cognitive Function
GenCov
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2020
CompletedFirst Posted
Study publicly available on registry
August 10, 2020
CompletedStudy Start
First participant enrolled
August 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedAugust 27, 2020
August 1, 2020
12 months
August 7, 2020
August 26, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Genetic variants with vs without COVID-19
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.
1 day
Cognitive function at baseline
Assess the cognitive status at baseline using MoCA survey in patients with vs without neurological symptoms
1 day
Secondary Outcomes (2)
Change in cognitive function at 1 month
1 month
Genetic analysis
1 day
Study Arms (2)
COVID-19 positive
COVID-19 negative
Interventions
MoCA survey to evaluate cognitive function in COVID-19 positive cases with vs without neurological symptoms
Eligibility Criteria
Known exposure to COVID-19 or confirmed cases of COVID-19
You may qualify if:
- 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
You may not qualify if:
- Unwilling to provide informed consent
- MoCA score ≤17 at baseline
- Patients with clinical diagnosis of dementia
- Impaired consciousness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Cardiac Arrhythmia Institute
Austin, Texas, 78705, United States
Biospecimen
Blood samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Natale
Texas Cardiac Arrhythmia Institute, St.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive Medical Director
Study Record Dates
First Submitted
August 7, 2020
First Posted
August 10, 2020
Study Start
August 20, 2020
Primary Completion
August 1, 2021
Study Completion
September 1, 2021
Last Updated
August 27, 2020
Record last verified: 2020-08