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

August 26, 2020 updated by: Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Bryan MacDonald
  • Phone Number: 5125447252

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Known exposure to COVID-19 or confirmed cases of COVID-19

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 positive
Genetic: Whole exome sequencing
MoCA survey to evaluate cognitive function in COVID-19 positive cases with vs without neurological symptoms
Other Names:
  • Cognitive function
COVID-19 negative
Genetic: Whole exome sequencing
MoCA survey to evaluate cognitive function in COVID-19 positive cases with vs without neurological symptoms
Other Names:
  • Cognitive function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic variants with vs without COVID-19
Time Frame: 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.
1 day
Cognitive function at baseline
Time Frame: 1 day
Assess the cognitive status at baseline using MoCA survey in patients with vs without neurological symptoms
1 day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Investigators

  • Principal Investigator: Andrea Natale, Texas Cardiac Arrhythmia Institute, St.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 20, 2020

Primary Completion (ANTICIPATED)

August 1, 2021

Study Completion (ANTICIPATED)

September 1, 2021

Study Registration Dates

First Submitted

August 7, 2020

First Submitted That Met QC Criteria

August 7, 2020

First Posted (ACTUAL)

August 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 27, 2020

Last Update Submitted That Met QC Criteria

August 26, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCAI_GenCov

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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