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

T

Texas Cardiac Arrhythmia Research Foundation

Status

Unknown

Conditions

Covid19

Treatments

Genetic: Whole exome sequencing

Study type

Observational

Funder types

Other

Identifiers

NCT04506229
TCAI_GenCov

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

COVID-19 positive
Treatment:
Genetic: Whole exome sequencing
COVID-19 negative
Treatment:
Genetic: Whole exome sequencing

Trial contacts and locations

1

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Central trial contact

Bryan MacDonald; Sanghamitra Mohanty

Data sourced from clinicaltrials.gov

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