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

Covid19 Clinical Trial

— GenCov  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04506229
• Other study ID #: TCAI_GenCov
• Status: Recruiting
• Start date: August 20, 2020
• Est. completion date: September 2021

Study information

• Verified date: August 2020
• Source: Texas Cardiac Arrhythmia Research Foundation
• Contact: Sanghamitra Mohanty
• Phone: 5127842651
• Email: mitra1989[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Infection

Intervention

Genetic:
• Whole exome sequencing
MoCA survey to evaluate cognitive function in COVID-19 positive cases with vs without neurological symptoms

Locations

Country	Name	City	State
United States	Texas Cardiac Arrhythmia Institute	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Cardiac Arrhythmia Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic variants with vs without COVID-19	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
Primary	Cognitive function at baseline	Assess the cognitive status at baseline using MoCA survey in patients with vs without neurological symptoms	1 day
Secondary	Change in cognitive function at 1 month	change in the MoCA score from baseline in patients with vs without neurological symptoms	1 month
Secondary	Genetic analysis	compare the genetic variants in patients with no or mild to moderate vs severe symptoms	1 day