<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04506229</url>
  </required_header>
  <id_info>
    <org_study_id>TCAI_GenCov</org_study_id>
    <nct_id>NCT04506229</nct_id>
  </id_info>
  <brief_title>Genetic Mechanisms Underlying SARS-CoV-2 Infection and the Impact of COVID-19 on Cognitive Function</brief_title>
  <acronym>GenCov</acronym>
  <official_title>Genetic Mechanisms Underlying SARS-CoV-2 Infection and the Impact of COVID-19 on Cognitive Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Cardiac Arrhythmia Research Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas Cardiac Arrhythmia Research Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a considerable variation in the disease behavior in terms of contracting the&#xD;
      infection, manifesting none to a range of symptoms and severity of the infection among&#xD;
      individuals exposed to or infected with SARS-CoV-2 virus, the causative organism of COVID-19.&#xD;
      Although the respiratory system appears to be the primary target of this virus infection,&#xD;
      emerging evidences suggests involvement of extra-pulmonary organs including central nervous&#xD;
      system. We aim to compare the genetic profile of individuals with vs without COVID-19 after&#xD;
      being exposed to infected cases. Additionally, we will assess the cognitive function in&#xD;
      covid-19 positive cases with vs. without neurological symptoms at the time of infection and&#xD;
      1-month follow-up using the Montreal Cognitive Assessment (MoCA) questionnaire.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 20, 2020</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">August 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Genetic variants with vs without COVID-19</measure>
    <time_frame>1 day</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive function at baseline</measure>
    <time_frame>1 day</time_frame>
    <description>Assess the cognitive status at baseline using MoCA survey in patients with vs without neurological symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in cognitive function at 1 month</measure>
    <time_frame>1 month</time_frame>
    <description>change in the MoCA score from baseline in patients with vs without neurological symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genetic analysis</measure>
    <time_frame>1 day</time_frame>
    <description>compare the genetic variants in patients with no or mild to moderate vs severe symptoms</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>COVID-19 positive</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>COVID-19 negative</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Whole exome sequencing</intervention_name>
    <description>MoCA survey to evaluate cognitive function in COVID-19 positive cases with vs without neurological symptoms</description>
    <arm_group_label>COVID-19 negative</arm_group_label>
    <arm_group_label>COVID-19 positive</arm_group_label>
    <other_name>Cognitive function</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Known exposure to COVID-19 or confirmed cases of COVID-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female over 18 years of age at the time of enrollment&#xD;
&#xD;
          2. Have symptoms of COVID-19 (with or without hospitalization) or contact history&#xD;
&#xD;
          3. Willing to undergo nasopharyngeal swab test for viral-RNA at baseline (in&#xD;
             non-hospitalized cases) and the MoCA survey at baseline and 1-month follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unwilling to provide informed consent&#xD;
&#xD;
          2. MoCA score ≤17 at baseline&#xD;
&#xD;
          3. Patients with clinical diagnosis of dementia&#xD;
&#xD;
          4. Impaired consciousness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea Natale</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Cardiac Arrhythmia Institute, St.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sanghamitra Mohanty</last_name>
    <phone>5127842651</phone>
    <email>mitra1989@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bryan MacDonald</last_name>
    <phone>5125447252</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Texas Cardiac Arrhythmia Institute</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sanghamitra Mohanty</last_name>
      <email>mitra1989@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 7, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 26, 2020</last_update_submitted>
  <last_update_submitted_qc>August 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Texas Cardiac Arrhythmia Research Foundation</investigator_affiliation>
    <investigator_full_name>Andrea Natale</investigator_full_name>
    <investigator_title>Executive Medical Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04506229
org study id: TCAI_GenCov
nct id: NCT04506229
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Only
time perspective: Prospective
measure: Genetic variants with vs without COVID-19
time frame: 1 day
description: 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.
measure: Cognitive function at baseline
time frame: 1 day
description: Assess the cognitive status at baseline using MoCA survey in patients with vs without neurological symptoms
measure: Change in cognitive function at 1 month
time frame: 1 month
description: change in the MoCA score from baseline in patients with vs without neurological symptoms
measure: Genetic analysis
time frame: 1 day
description: compare the genetic variants in patients with no or mild to moderate vs severe symptoms
arm group label: COVID-19 positive
arm group label: COVID-19 negative
intervention type: Genetic
intervention name: Whole exome sequencing
description: MoCA survey to evaluate cognitive function in COVID-19 positive cases with vs without neurological symptoms
arm group label: COVID-19 negative
arm group label: COVID-19 positive
other name: Cognitive function
Blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrea Natale
role: Principal Investigator
affiliation: Texas Cardiac Arrhythmia Institute, St.
last name: Sanghamitra Mohanty
phone: 5127842651
email: mitra1989@gmail.com
last name: Bryan MacDonald
phone: 5125447252
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Texas Cardiac Arrhythmia Research Foundation
investigator full name: Andrea Natale
investigator title: Executive Medical Director
mesh term: COVID-19
sharing ipd: Undecided