<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/NCT04402814</url>
  </required_header>
  <id_info>
    <org_study_id>IgG/IgM COVID19</org_study_id>
    <secondary_id>2005801</secondary_id>
    <nct_id>NCT04402814</nct_id>
  </id_info>
  <brief_title>IgG/IgM Antibody Test in Patients Who Have Tested Negative or Positive for COVID-19 With the Standard Method of COVID19 Testing.</brief_title>
  <official_title>Evaluation and Correlation of SARS-Cov2 Virus IgG/IgM Rapid Test Cassette Clungene Test With the Standard Method of COVID19 Testing in Inpatients With or Without COVID19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fadi Haddad, M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sharp HealthCare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate point of care SARS-Cov2 Virus IgG/IgM rapid test&#xD;
      cassette Clungene test and correlate it with the standard method of testing in inpatients who&#xD;
      have tested positive or negative for COVID19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a laboratory testing study using the SARS-Cov2 Virus IgG/IgM rapid test cassette&#xD;
      Clungene test to determine the presence of IgM and IgG antibodies in subjects who have tested&#xD;
      negative or positive for COVID-19. The study is observational and subjects will be assigned&#xD;
      to one of two arms depending on the results of their nCOVID-19 test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 5, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>IgG/IgM antibodies</measure>
    <time_frame>from date of consent to date of test completion, up to 40 days</time_frame>
    <description>Presence of IgG and/or IgM antibodies</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">90</enrollment>
  <condition>SARS-CoV 2</condition>
  <arm_group>
    <arm_group_label>Arm A (positive for COVID-19)</arm_group_label>
    <description>One or two samples of your blood that were previously collected for routine care will be obtained from the hospital laboratory and will be tested for the antibodies against COVID-19 virus.&#xD;
First blood sample obtained: 7 to 12 days following onset of symptoms; and/or&#xD;
Second blood sample obtained: 12 to 40 days following the onset of symptoms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (negative for COVID-19)</arm_group_label>
    <description>One sample of blood that was collected for routine care at any point during hospitalization will be obtained from the hospital laboratory and will be tested for the antibodies.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Clungene rapid test cassette</intervention_name>
    <description>Blood will be tested for the presence of IgG and IgM antibodies using the Clungene rapid test cassette.</description>
    <arm_group_label>Arm A (positive for COVID-19)</arm_group_label>
    <arm_group_label>Arm B (negative for COVID-19)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized (or recently discharged) subjects who have been previously tested for COVID-19&#xD;
        with the standard method of testing.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Received confirmed COVID-19 positive or negative test from Sharp HealthCare's standard&#xD;
             method of testing.&#xD;
&#xD;
          -  Age &gt;/=18 years old.&#xD;
&#xD;
          -  Access to a phone in the hospital room or an electronic device that is capable of&#xD;
             receiving phone calls and/or video calls and/or e-mail.&#xD;
&#xD;
          -  Able to read/write/speak English or Spanish fluently.&#xD;
&#xD;
          -  Subjects must have the ability to understand the requirements of the study, provide&#xD;
             informed consent, and provide authorization of use and disclosure of personal health&#xD;
             information.&#xD;
&#xD;
          -  Hospitalized at the time of consent or recently discharged with leftover blood stored&#xD;
             at hospital laboratory&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Impaired cognitive or decision-making capacity (based on the clinical judgment of the&#xD;
             PI or designee)&#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>Fadi Haddad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sharp HealthCare</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kathryn Miller</last_name>
    <phone>858-939-7162</phone>
    <email>kathryn.miller@sharp.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Divina Fanning, RN</last_name>
    <phone>(619)823-7347</phone>
    <email>divina.fanning@sharp.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fadi A. Haddad MD Inc.</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Divina Fanning, RN</last_name>
      <phone>619-823-7347</phone>
      <email>divina.fanning@sharp.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sharp Grossmont Hospital</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Divina Fanning, RN</last_name>
      <phone>619-823-7347</phone>
      <email>divina.fanning@sharp.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sharp Memorial Hosptial</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Divina Fanning, RN</last_name>
      <phone>619-823-7347</phone>
      <email>divina.fanning@sharp.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sharp HealthCare</investigator_affiliation>
    <investigator_full_name>Fadi Haddad, M.D.</investigator_full_name>
    <investigator_title>Infectious Disease Specialist</investigator_title>
  </responsible_party>
  <keyword>Coronavirus</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Clungene</keyword>
  <keyword>IgG/IgM antibodies</keyword>
  <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/NCT04402814
org study id: IgG/IgM COVID19
secondary id: 2005801
nct id: NCT04402814
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The purpose of this study is to evaluate point of care SARS-Cov2 Virus IgG/IgM rapid test
      cassette Clungene test and correlate it with the standard method of testing in inpatients who
      have tested positive or negative for COVID19.
This is a laboratory testing study using the SARS-Cov2 Virus IgG/IgM rapid test cassette
      Clungene test to determine the presence of IgM and IgG antibodies in subjects who have tested
      negative or positive for COVID-19. The study is observational and subjects will be assigned
      to one of two arms depending on the results of their nCOVID-19 test.
observational model: Cohort
time perspective: Prospective
measure: IgG/IgM antibodies
time frame: from date of consent to date of test completion, up to 40 days
description: Presence of IgG and/or IgM antibodies
arm group label: Arm A (positive for COVID-19)
description: One or two samples of your blood that were previously collected for routine care will be obtained from the hospital laboratory and will be tested for the antibodies against COVID-19 virus.
First blood sample obtained: 7 to 12 days following onset of symptoms; and/or
Second blood sample obtained: 12 to 40 days following the onset of symptoms.
arm group label: Arm B (negative for COVID-19)
description: One sample of blood that was collected for routine care at any point during hospitalization will be obtained from the hospital laboratory and will be tested for the antibodies.
intervention type: Diagnostic Test
intervention name: Clungene rapid test cassette
description: Blood will be tested for the presence of IgG and IgM antibodies using the Clungene rapid test cassette.
arm group label: Arm A (positive for COVID-19)
arm group label: Arm B (negative for COVID-19)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fadi Haddad, MD
role: Principal Investigator
affiliation: Sharp HealthCare
last name: Kathryn Miller
phone: 858-939-7162
email: kathryn.miller@sharp.com
last name: Divina Fanning, RN
phone: (619)823-7347
email: divina.fanning@sharp.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Sharp HealthCare
investigator full name: Fadi Haddad, M.D.
investigator title: Infectious Disease Specialist
mesh term: COVID-19
sharing ipd: No