Recruiting

Genetic Mechanisms

Sponsor:

Texas Cardiac Arrhythmia Research Foundation

Code:

NCT04506229

Conditions

Covid19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Whole exome sequencing

Study Details

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.

Conditions

Covid19

Study ID

NCT04506229

Start date

Aug 20, 2020

Status verified date

Aug, 2020

Completion date

Sep, 2021

Anticipated

Primary completion date

Aug, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

COVID-19 positive

COVID-19 negative

Interventions

Whole exome sequencing

MoCA survey to evaluate cognitive function in COVID-19 positive cases with vs without neurological symptoms

Primary outcome measure

  • Genetic variants with vs without COVID-19 [ Time Frame: 1 day ]
  • Cognitive function at baseline [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Bryan MacDonald

5125447252

Locations

Texas Cardiac Arrhythmia Institute

Recruiting

Austin, Texas, United States, 78705

Contacts

Sanghamitra Mohanty

mitra1989@gmail.com

More Information

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Last update posted

Aug 27, 2020

Last verified

Aug, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Cardiac Arrhythmia Research Foundation on 2020-08-27.