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

NCT ID: NCT04506229

Last Updated: 2020-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-20

Study Completion Date

2021-09-30

Brief Summary

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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

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Conditions

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Covid19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 positive

Whole exome sequencing

Intervention Type GENETIC

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

COVID-19 negative

Whole exome sequencing

Intervention Type GENETIC

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

Interventions

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Whole exome sequencing

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

Intervention Type GENETIC

Other Intervention Names

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Cognitive function

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Texas Cardiac Arrhythmia Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Andrea Natale

Executive Medical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Natale

Role: PRINCIPAL_INVESTIGATOR

Texas Cardiac Arrhythmia Institute, St.

Locations

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Texas Cardiac Arrhythmia Institute

Austin, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sanghamitra Mohanty

Role: CONTACT

5127842651

Bryan MacDonald

Role: CONTACT

5125447252

Facility Contacts

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Sanghamitra Mohanty

Role: primary

Other Identifiers

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TCAI_GenCov

Identifier Type: -

Identifier Source: org_study_id

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