Genetic Mechanisms Underlying SARS-CoV-2 Infection and the Impact of COVID-19 on Cognitive Function

• Conditions: Covid19
• Interventions: Genetic: Whole exome sequencing

• Registration Number: NCT04506229
• Lead Sponsor: Texas Cardiac Arrhythmia Research Foundation

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-07
• Study First Submitted QC: 2020-08-07
• Study First Posted: 2020-08-10
• Study Start: 2020-08-20
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-27
• Primary Completion: 2021-08
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male or female over 18 years of age at the time of enrollment
2. Have symptoms of COVID-19 (with or without hospitalization) or contact history
3. 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

1. Unwilling to provide informed consent
2. MoCA score ≤17 at baseline
3. Patients with clinical diagnosis of dementia
4. Impaired consciousness

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 negative	Whole exome sequencing	-
COVID-19 positive	Whole exome sequencing	-

Primary Outcome Measures

Name	Time	Method
Genetic variants with vs without COVID-19	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	1 day	Assess the cognitive status at baseline using MoCA survey in patients with vs without neurological symptoms

Secondary Outcome Measures

Name	Time	Method
Change in cognitive function at 1 month	1 month	change in the MoCA score from baseline in patients with vs without neurological symptoms
Genetic analysis	1 day	compare the genetic variants in patients with no or mild to moderate vs severe symptoms

Trial Locations

Locations (1)

Texas Cardiac Arrhythmia Institute; 🇺🇸 Austin, Texas, United States