<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/NCT04465981</url>
  </required_header>
  <id_info>
    <org_study_id>INANO-CV1</org_study_id>
    <nct_id>NCT04465981</nct_id>
  </id_info>
  <brief_title>Investigation of Antibody and Immune Responses to SARS-CoV-2 Proteins in COVID-19 Patients</brief_title>
  <acronym>SARS-CoV-2</acronym>
  <official_title>A Longitudinal, Non-randomized Study to Evaluate the Utility of the INanoBio's Protein Arrays in Detecting Unique Antibodies in COVID-19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>INanoBio Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>TMC HealthCare</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>INanoBio Inc.</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>
      SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has negatively&#xD;
      impacted global health and requires more research to develop better tests and to improve&#xD;
      disease treatment.&#xD;
&#xD;
      The purpose of this research is to aid in the testing effort by collecting samples from&#xD;
      people who have been diagnosed with COVID-19 or are suspected of having COVID-19. Samples you&#xD;
      provide will be used investigationally by INanoBio to develop a test to determine when&#xD;
      antibodies against various SARS-CoV-2 proteins are detectable.&#xD;
&#xD;
      Up to approximately 80 subjects of all ages with either a suspected or lab-confirmed&#xD;
      diagnosis of COVID-19 will take part in this research.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A longitudinal, non-randomized study to evaluate the utility of the INanoBio's protein arrays&#xD;
      in detecting unique antibodies in COVID-19 patients. To study the feasibility of utilizing a&#xD;
      viral proteome microarray for evaluating exposure status, immunity status, diagnosis, and&#xD;
      prognosis of SARS-CoV-2 infections during and after the course of disease. The sample size is&#xD;
      to include 80 subjects: 40 diagnosed with COVID-19 and 40 suspected to have COVID-19. The&#xD;
      goal will be to assess antibodies throughout the subject's disease course compared to&#xD;
      controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 3, 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Serological identification of individuals who have been infected with SARS-CoV-2</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Distinguish individuals who have been infected with SARS-CoV-2 from those who have not using antibody-based assays and measure antibody levels as a function of time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identify antibody and/or immune signatures in COVID-19 patients</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Analyze and identify antibody and/or immune signatures in COVID-19 patients that differentiate patients with severe disease versus those without, and determine which antigens are most useful for serological testing</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>COVID-19</condition>
  <condition>SARS-CoV-2 Infection</condition>
  <arm_group>
    <arm_group_label>Patients with lab-confirmed COVID-19</arm_group_label>
    <description>Subject has lab-confirmed diagnosis of COVID-19 by RT-PCR</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients who are suspected to have or are confirmed to not have COVID-19</arm_group_label>
    <description>Subject has suspected COVID-19 according to medical evaluation, but does not yet have lab-confirmed diagnosis of COVID-19 (results outstanding, or has tested negative by RT-PCR)</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Sampling</intervention_name>
    <description>Test is to validate the utility of INanoBio's automated protein arrays in detecting antibodies against SARS-CoV-2 proteins.</description>
    <arm_group_label>Patients who are suspected to have or are confirmed to not have COVID-19</arm_group_label>
    <arm_group_label>Patients with lab-confirmed COVID-19</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum will be isolated from periodic clinical blood specimens during the entire duration of&#xD;
      the patient's hospital stay. Whole blood and plasma may also be collected. The CoV-2 protein&#xD;
      serology assay will be performed on each sample.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        COVID-19 tested patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subject must meet all of the following criteria to be eligible for treatment in the study:&#xD;
&#xD;
          1. Subject or legal representative understands the nature of the procedure and has signed&#xD;
             the Subject Informed Consent Form prior to study procedures&#xD;
&#xD;
          2. For the COVID-19 Cohort&#xD;
&#xD;
               -  Subject has lab-confirmed diagnosis of COVID-19 by RT-PCR&#xD;
&#xD;
          3. For the PUI Cohort&#xD;
&#xD;
               -  Subject has suspected COVID-19 according to medical evaluation, but does not yet&#xD;
                  have lab-confirmed diagnosis of COVID-19 (results outstanding, or has tested&#xD;
                  negative by RT-PCR)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject or legal representative not willing to consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Katherine Scott</last_name>
    <role>Principal Investigator</role>
    <affiliation>TMC HealthCare</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Natalia Elias Calles, MPH</last_name>
    <phone>5203275461</phone>
    <email>Research@tmcaz.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>TMC HealthCare</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natalia Elias Calles, MPH</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>August 23, 2021</last_update_submitted>
  <last_update_submitted_qc>August 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>No</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/NCT04465981
org study id: INANO-CV1
nct id: NCT04465981
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has negatively
      impacted global health and requires more research to develop better tests and to improve
      disease treatment.

      The purpose of this research is to aid in the testing effort by collecting samples from
      people who have been diagnosed with COVID-19 or are suspected of having COVID-19. Samples you
      provide will be used investigationally by INanoBio to develop a test to determine when
      antibodies against various SARS-CoV-2 proteins are detectable.

      Up to approximately 80 subjects of all ages with either a suspected or lab-confirmed
      diagnosis of COVID-19 will take part in this research.
A longitudinal, non-randomized study to evaluate the utility of the INanoBio's protein arrays
      in detecting unique antibodies in COVID-19 patients. To study the feasibility of utilizing a
      viral proteome microarray for evaluating exposure status, immunity status, diagnosis, and
      prognosis of SARS-CoV-2 infections during and after the course of disease. The sample size is
      to include 80 subjects: 40 diagnosed with COVID-19 and 40 suspected to have COVID-19. The
      goal will be to assess antibodies throughout the subject's disease course compared to
      controls.
observational model: Cohort
time perspective: Other
measure: Serological identification of individuals who have been infected with SARS-CoV-2
time frame: Through study completion, an average of 1 year
description: Distinguish individuals who have been infected with SARS-CoV-2 from those who have not using antibody-based assays and measure antibody levels as a function of time
measure: Identify antibody and/or immune signatures in COVID-19 patients
time frame: Through study completion, an average of 1 year
description: Analyze and identify antibody and/or immune signatures in COVID-19 patients that differentiate patients with severe disease versus those without, and determine which antigens are most useful for serological testing
arm group label: Patients with lab-confirmed COVID-19
description: Subject has lab-confirmed diagnosis of COVID-19 by RT-PCR
arm group label: Patients who are suspected to have or are confirmed to not have COVID-19
description: Subject has suspected COVID-19 according to medical evaluation, but does not yet have lab-confirmed diagnosis of COVID-19 (results outstanding, or has tested negative by RT-PCR)
intervention type: Diagnostic Test
intervention name: Sampling
description: Test is to validate the utility of INanoBio's automated protein arrays in detecting antibodies against SARS-CoV-2 proteins.
arm group label: Patients who are suspected to have or are confirmed to not have COVID-19
arm group label: Patients with lab-confirmed COVID-19
Serum will be isolated from periodic clinical blood specimens during the entire duration of
      the patient's hospital stay. Whole blood and plasma may also be collected. The CoV-2 protein
      serology assay will be performed on each sample.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Katherine Scott
role: Principal Investigator
affiliation: TMC HealthCare
last name: Natalia Elias Calles, MPH
phone: 5203275461
email: Research@tmcaz.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No