<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/NCT04434417</url>
  </required_header>
  <id_info>
    <org_study_id>I-GLOBAL</org_study_id>
    <nct_id>NCT04434417</nct_id>
  </id_info>
  <brief_title>Validation of an Immunochromatographic Assay for IgG/IgM Antibodies to 2019- nCoV</brief_title>
  <acronym>I-GLOBAL</acronym>
  <official_title>Clinical Validation of a Simple and Fast Immunochromatographic Assay for Qualitative Determination of Specific ImmunoGLObulin IgG/IgM Antibodies to 2019- nCoV in Whole bLood, Serum or Plasma Specimen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Institute of Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Azienda Socio Sanitaria Territoriale di Cremona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Azienda Ospedaliera Niguarda Cà Granda</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Papa Giovanni XXIII Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>European Institute of Oncology</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>
      In COVID-19 pandemic, it is of critical importance to identify a rapid and simple diagnostic&#xD;
      method to be used in clinical settings to timely inform and refine strategies that can&#xD;
      prevent, control, and stop the spread of SARS-CoV-2. The 2019-nCoV IgG/IgM Rapid Test&#xD;
      Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane-based immunoassay for the&#xD;
      detection of immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies to SARS-CoV-2 in&#xD;
      whole blood, serum or plasma specimen. Clinical specimens from patients who were suspected of&#xD;
      being infected with 2019-nCoV will be used to evaluate the performance of the assay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In COVID-19 pandemic, it is of critical importance to identify a rapid and simple diagnostic&#xD;
      method to be used in clinical settings to timely inform and refine strategies that can&#xD;
      prevent, control, and stop the spread of SARS-CoV-2. The 2019-nCoV IgG/IgM Rapid Test&#xD;
      Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane-based immunoassay for the&#xD;
      detection of Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies to SARS-CoV-2in&#xD;
      whole blood, serum or plasma specimen. This test consists of two components, an IgG component&#xD;
      and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region.&#xD;
      During testing, the specimen reacts with 2019-nCoV antigen-coated particles in the test&#xD;
      cassette. The mixture then migrates upward on the membrane chromatographically by capillary&#xD;
      action and reacts with the anti-human IgG in IgG test line region, if the specimen contains&#xD;
      IgG antibodies to SARS-CoV-2. The study aims to validate in a real life study a self&#xD;
      diagnostic assay for SARS-CoV-2 with the advantages of high speed, simple operation and low&#xD;
      cost, and overcomes the shortcomings of the existing molecular detection methods. Clinical&#xD;
      specimens from patients who were suspected of being infected with 2019-nCoV will be used to&#xD;
      evaluate the performance of the assay. In parallel, we will also use molecular assays for the&#xD;
      detection of the presence of the viral RNA from nasopharyngeal swabs since Polymerase Chain&#xD;
      Reaction is currently the gold standard.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 2021</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>Evaluation of the rate of SARS-CoV-2 positive cancer patients and health professionals in a comprehensive cancer center or in a cancer setting.</measure>
    <time_frame>6 months</time_frame>
    <description>Patients positive are serially tested with SARSCoV-2 lgM / IgG Rapid Test to evaluate the immune response in IgG negative patients and the reliability of the test in those patients who develop clinical signs of SARS-CoV-2 during the trial.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of test accuracy</measure>
    <time_frame>3 months</time_frame>
    <description>The 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) was compared with a leading commercial Polymerase Chain Reaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interleukin-6 quantification</measure>
    <time_frame>3 months</time_frame>
    <description>Multiplex immunoassay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interleukin-2 quantification</measure>
    <time_frame>3 months</time_frame>
    <description>Multiplex immunoassay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interleukin-1 quantification</measure>
    <time_frame>6 months</time_frame>
    <description>Multiplex immunoassay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor Necrosis Factor (TNF) quantification</measure>
    <time_frame>3 months</time_frame>
    <description>Multiplex immunoassay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interferon gamma quantification</measure>
    <time_frame>3 months</time_frame>
    <description>Multiplex immunoassay</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1000</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Cohort tested</arm_group_label>
    <description>The cohort will include patients or health professionals who patients who were suspected of being infected with 2019-nCoV</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>2019-nCoV IgG/IgM Rapid Test Cassette</intervention_name>
    <description>The specimen (whole blood, serum, plasma) will be loaded into the cassette and will migrate via capillary action along the membrane to react with the gold conjugate. The result will be available in 10 minutes</description>
    <arm_group_label>Cohort tested</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study population includes:&#xD;
&#xD;
          -  Patients or health professionals already tested positive for the viral RNA from&#xD;
             nasopharyngeal swabs by RT-PCR&#xD;
&#xD;
          -  Patients or health professional who are suspected of being infected with SARS-CoV-2 in&#xD;
             the hospital&#xD;
&#xD;
          -  Patients who are considered at high risk for infection and eligible for active therapy&#xD;
             and major surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Suspected cases who meet the following 2 criteria at the same time:&#xD;
&#xD;
               1. Epidemiological history: There was a history of contact with confirmed cases&#xD;
                  before the onset of illness; or subjects with at least one symptom in the last&#xD;
                  week before accrual in the trial. Subjects who have been in contact with people&#xD;
                  positive for SARS-CoV-2 in the previous 14 days.&#xD;
&#xD;
               2. Clinical manifestations are defined as :&#xD;
&#xD;
             Fever &gt;37.5°; dry cough, muscle pain and/or fatigue, anosmia, subjects with&#xD;
             respiratory distress (Respiratory Rate &gt;25/min or O2 Saturation &lt;92%) or imaging&#xD;
             characteristics of pneumonia; or the total number of white blood cells is normal or&#xD;
             decreased with the lymphocyte count decreased in the early stage of onset or there is&#xD;
             an abnormal C-Reactive protein. Other symptoms that clinical investigator will relate&#xD;
             to SARS-CoV-2 infection. Subject or cancer patients who have been quarantined for&#xD;
             suspect symptoms and have access to hospital to continue therapy or to receive major&#xD;
             surgery&#xD;
&#xD;
          2. Confirmed cases, namely patients or subjects with positive Reverse&#xD;
             Transcription-Polymerase Chain Reaction (RT-PCR) for SARS-CoV-2. On the basis of&#xD;
             meeting the criteria for suspected cases, sputum, throat swabs, lower respiratory&#xD;
             tract secretions, and other specimens are tested by realtime RT-PCR for positive&#xD;
             nucleic acid detection of new coronavirus; or viral gene sequencing is highly&#xD;
             homologous with known new coronaviruses. Patients positive are serially tested with&#xD;
             SARS-CoV-2 lgM / IgG Rapid Test to evaluate the immune response in IgG negative&#xD;
             patients and the reliability of the test in those patients who develop clinical signs&#xD;
             of SARS-CoV-2 during the trial.&#xD;
&#xD;
          3. Patients who are considered at high risk for infection and eligible for active therapy&#xD;
             and major surgery&#xD;
&#xD;
               -  Frailty (age and multiple comorbidities) planned to receive a standard systemic&#xD;
                  anticancer treatment comprising chemotherapy and/or immunotherapy and/or&#xD;
                  radiation therapy or to receive an experimental treatment&#xD;
&#xD;
               -  Major surgery or surgery after neoadjuvant chemotherapy and or chemo/radiotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Ascertained influenza virus, parainfluenza virus, adenovirus, respiratory syncytial&#xD;
             virus, rhinovirus, human metapneumovirus, Severe Acute Respiratory Syndrome&#xD;
             coronavirus, and other known other viral pneumonia;&#xD;
&#xD;
          2. Ascertained mycoplasma pneumoniae, chlamydia pneumonia, and bacterial pneumonia;&#xD;
             non-infectious diseases such as vasculitis, dermatomyositis, and organizing pneumonia.&#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>Giuseppe Curigliano, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>European IO</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Antonio Marra, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>European IO</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Papa Giovanni XXIII Hospital</name>
      <address>
        <city>Bergamo</city>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Socio-Sanitaria Territoriale di Cremona</name>
      <address>
        <city>Cremona</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Niguarda Cà Granda</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>European IO, Division of Early Drug Development for Innovative Therapies</name>
      <address>
        <city>Milan</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>May 12, 2022</last_update_submitted>
  <last_update_submitted_qc>May 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>immunoassay</keyword>
  <keyword>immunoglobulin IgM</keyword>
  <keyword>immunoglobulin IgG</keyword>
  <keyword>cancer</keyword>
  <keyword>COVID</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD will be available upon request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>At the end of the study</ipd_time_frame>
    <ipd_access_criteria>Upon request</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT04434417/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04434417
org study id: I-GLOBAL
nct id: NCT04434417
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In COVID-19 pandemic, it is of critical importance to identify a rapid and simple diagnostic
      method to be used in clinical settings to timely inform and refine strategies that can
      prevent, control, and stop the spread of SARS-CoV-2. The 2019-nCoV IgG/IgM Rapid Test
      Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane-based immunoassay for the
      detection of immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies to SARS-CoV-2 in
      whole blood, serum or plasma specimen. Clinical specimens from patients who were suspected of
      being infected with 2019-nCoV will be used to evaluate the performance of the assay.
In COVID-19 pandemic, it is of critical importance to identify a rapid and simple diagnostic
      method to be used in clinical settings to timely inform and refine strategies that can
      prevent, control, and stop the spread of SARS-CoV-2. The 2019-nCoV IgG/IgM Rapid Test
      Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane-based immunoassay for the
      detection of Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies to SARS-CoV-2in
      whole blood, serum or plasma specimen. This test consists of two components, an IgG component
      and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region.
      During testing, the specimen reacts with 2019-nCoV antigen-coated particles in the test
      cassette. The mixture then migrates upward on the membrane chromatographically by capillary
      action and reacts with the anti-human IgG in IgG test line region, if the specimen contains
      IgG antibodies to SARS-CoV-2. The study aims to validate in a real life study a self
      diagnostic assay for SARS-CoV-2 with the advantages of high speed, simple operation and low
      cost, and overcomes the shortcomings of the existing molecular detection methods. Clinical
      specimens from patients who were suspected of being infected with 2019-nCoV will be used to
      evaluate the performance of the assay. In parallel, we will also use molecular assays for the
      detection of the presence of the viral RNA from nasopharyngeal swabs since Polymerase Chain
      Reaction is currently the gold standard.
observational model: Cohort
time perspective: Prospective
measure: Evaluation of the rate of SARS-CoV-2 positive cancer patients and health professionals in a comprehensive cancer center or in a cancer setting.
time frame: 6 months
description: Patients positive are serially tested with SARSCoV-2 lgM / IgG Rapid Test to evaluate the immune response in IgG negative patients and the reliability of the test in those patients who develop clinical signs of SARS-CoV-2 during the trial.
measure: Evaluation of test accuracy
time frame: 3 months
description: The 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) was compared with a leading commercial Polymerase Chain Reaction
measure: Interleukin-6 quantification
time frame: 3 months
description: Multiplex immunoassay
measure: Interleukin-2 quantification
time frame: 3 months
description: Multiplex immunoassay
measure: Interleukin-1 quantification
time frame: 6 months
description: Multiplex immunoassay
measure: Tumor Necrosis Factor (TNF) quantification
time frame: 3 months
description: Multiplex immunoassay
measure: Interferon gamma quantification
time frame: 3 months
description: Multiplex immunoassay
arm group label: Cohort tested
description: The cohort will include patients or health professionals who patients who were suspected of being infected with 2019-nCoV
intervention type: Device
intervention name: 2019-nCoV IgG/IgM Rapid Test Cassette
description: The specimen (whole blood, serum, plasma) will be loaded into the cassette and will migrate via capillary action along the membrane to react with the gold conjugate. The result will be available in 10 minutes
arm group label: Cohort tested
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Giuseppe Curigliano, MD
role: Principal Investigator
affiliation: European IO
last name: Antonio Marra, MD
role: Principal Investigator
affiliation: European IO
facility: 
facility: 
facility: 
facility: 
facility: 
country: Italy
responsible party type: Sponsor
sharing ipd: Yes
ipd description: IPD will be available upon request
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: At the end of the study
ipd access criteria: Upon request
provided document: 