<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/NCT04490837</url>
  </required_header>
  <id_info>
    <org_study_id>2020/587</org_study_id>
    <nct_id>NCT04490837</nct_id>
  </id_info>
  <brief_title>Rapid Diagnostic Test for COVID-19 Based on Antibody Detection (YCOVID)</brief_title>
  <acronym>YCOVID</acronym>
  <official_title>Rapid Diagnostic Test for COVID-19 Based on Antibody Detection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corporacion Parc Tauli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corporacion Parc Tauli</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Ycovid-19 aims to be a rapid diagnostic test for SARS-CoV-2 infection, which will allow a&#xD;
      reliable diagnosis to be made in 10 minutes, and on easy-to-use devices. This test will be&#xD;
      developed using innovative technology developed at the Parc Taulí University Hospital, which&#xD;
      increases the immunogenicity of SARS-CoV-2 differential antigens. The increased&#xD;
      immunogenicity of these antigens will allow to detect, with a high sensitivity and&#xD;
      specificity, the antibodies in the serum of patients infected with SARS-CoV-2. This test will&#xD;
      serve to confirm dubious results as well as reduce false negatives from the PCR test, which&#xD;
      will ultimately help reduce transmission of the infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2020</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>IgG anti-COVID-19</measure>
    <time_frame>From May to July</time_frame>
    <description>IgG antibodies against COVID-19 RBD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IgM anti-COVID-19</measure>
    <time_frame>From May to July</time_frame>
    <description>IgM antibodies against COVID-19 RBD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IgA anti-COVID-19</measure>
    <time_frame>From May to July</time_frame>
    <description>IgA antibodies against COVID-19 RBD</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time of onset symptoms</measure>
    <time_frame>From May to July</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COVID-19 PCR results</measure>
    <time_frame>From May to July</time_frame>
    <description>Qualitative result to clasify patients into PCR COVID-19 positive patients and PCR COVID-19 negative patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological studies</measure>
    <time_frame>From May to July</time_frame>
    <description>The presence or abcense of the typical image of the pneumonia caused by COVID-19</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">3500</enrollment>
  <condition>Covid-19</condition>
  <arm_group>
    <arm_group_label>COVID-19 positive</arm_group_label>
    <description>Patients with clinical, radiological and/or PCR positive for COVID-19 infection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal</arm_group_label>
    <description>Normal human serum from blood donnors before COVID-19 pandemia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pathological controls</arm_group_label>
    <description>Patients with other positive virological serologies</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ELISA and Rapid test to detect antibodies against COVID-19</intervention_name>
    <description>Ycovid-19 aims to be a rapid diagnostic test for SARS-CoV-2 infection, which will allow a reliable diagnosis to be made in 10 minutes, and on easy-to-use devices</description>
    <arm_group_label>COVID-19 positive</arm_group_label>
    <arm_group_label>Normal</arm_group_label>
    <arm_group_label>Pathological controls</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma or serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with COVID-19 infection Professionals of an University Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Professional from Parc Taulí University Hospital&#xD;
&#xD;
          -  Patients with clinical, radiological and/or PCR COVID-19 positive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients or professionals who do not sign informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Parc Tauli University Hospital</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 28, 2021</last_update_submitted>
  <last_update_submitted_qc>July 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Corporacion Parc Tauli</investigator_affiliation>
    <investigator_full_name>Juan Francisco Delgado de la Poza</investigator_full_name>
    <investigator_title>Senior Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Antibodies</keyword>
  <keyword>Covid-19</keyword>
  <keyword>Rapid test</keyword>
  <keyword>RBD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
  </intervention_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/NCT04490837
org study id: 2020/587
nct id: NCT04490837
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Ycovid-19 aims to be a rapid diagnostic test for SARS-CoV-2 infection, which will allow a
      reliable diagnosis to be made in 10 minutes, and on easy-to-use devices. This test will be
      developed using innovative technology developed at the Parc Taulí University Hospital, which
      increases the immunogenicity of SARS-CoV-2 differential antigens. The increased
      immunogenicity of these antigens will allow to detect, with a high sensitivity and
      specificity, the antibodies in the serum of patients infected with SARS-CoV-2. This test will
      serve to confirm dubious results as well as reduce false negatives from the PCR test, which
      will ultimately help reduce transmission of the infection.
observational model: Case-Control
time perspective: Prospective
measure: IgG anti-COVID-19
time frame: From May to July
description: IgG antibodies against COVID-19 RBD
measure: IgM anti-COVID-19
time frame: From May to July
description: IgM antibodies against COVID-19 RBD
measure: IgA anti-COVID-19
time frame: From May to July
description: IgA antibodies against COVID-19 RBD
measure: Time of onset symptoms
time frame: From May to July
measure: COVID-19 PCR results
time frame: From May to July
description: Qualitative result to clasify patients into PCR COVID-19 positive patients and PCR COVID-19 negative patients
measure: Radiological studies
time frame: From May to July
description: The presence or abcense of the typical image of the pneumonia caused by COVID-19
arm group label: COVID-19 positive
description: Patients with clinical, radiological and/or PCR positive for COVID-19 infection
arm group label: Normal
description: Normal human serum from blood donnors before COVID-19 pandemia
arm group label: Pathological controls
description: Patients with other positive virological serologies
intervention type: Diagnostic Test
intervention name: ELISA and Rapid test to detect antibodies against COVID-19
description: Ycovid-19 aims to be a rapid diagnostic test for SARS-CoV-2 infection, which will allow a reliable diagnosis to be made in 10 minutes, and on easy-to-use devices
arm group label: COVID-19 positive
arm group label: Normal
arm group label: Pathological controls
Plasma or serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Corporacion Parc Tauli
investigator full name: Juan Francisco Delgado de la Poza
investigator title: Senior Medical Doctor
mesh term: COVID-19
mesh term: Antibodies
sharing ipd: Undecided