<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/NCT04505709</url>
  </required_header>
  <id_info>
    <org_study_id>STOP-Coronavirus</org_study_id>
    <secondary_id>COV20/00181</secondary_id>
    <nct_id>NCT04505709</nct_id>
  </id_info>
  <brief_title>Clinical, Immunological, Genomic, Virological and Bioethical Actors of COVID-19</brief_title>
  <official_title>STOP-Coronavirus: Clinical, Immunological, Genomic, Virological and Bioethical Actors of COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Universitario 12 de Octubre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fundacion Investigacion Biomedica Hospital 12 de Octubre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Universitario Fundación Jiménez Díaz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Universitario Infanta Elena</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Universitario Virgen de la Arrixaca</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz</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>
      The STOP-Coronavirus project is an integrated and multidisciplinary study that aims to&#xD;
      analyze the impact that various factors have on the evolution and prognosis of the current&#xD;
      COVID-19. Clinical presentation, immunological markers, therapeutic strategies, host and&#xD;
      virus genomics, and bioethical considerations will be analyzed with a prospective multicenter&#xD;
      cohort of patients with a diagnosis of COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project led my Dr Aguado Garcia, has established 8 Work Parckages (WP) to analyze&#xD;
      factors involved in the impact of COVID-19. WP that correspond to University Hospital&#xD;
      Fundacion Jimenez Diaz are described in this register across different objectives:&#xD;
&#xD;
      WP 3 (Dr Ayuso García) is aimed to analyze the genetic markers of host susceptibility&#xD;
      associated with clinical evolution of COVID-19.&#xD;
&#xD;
      WP 6 (Dr Ruiz Hornillos) will study the socio-economic and bioethical repercussions of&#xD;
      COVID-19.&#xD;
&#xD;
      WP 7 (Dr Perales) will analyze the complexity of the spectrum of SARS-CoV-2 mutants and their&#xD;
      possible association with the evolutionary course of COVID-19&#xD;
&#xD;
      This project will guide and individualize the clinical and therapeutic approach to COVID-19&#xD;
      and mitigate the health and social impact of the pandemic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Identification of host genetic markers associated with the evolution of COVID-19</measure>
    <time_frame>4 months</time_frame>
    <description>Based on the cohort of patients with a confirmed diagnosis of COVID-19 and according to severity categories, a Genome-wide association study (GWAS) will be carried out</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analysis of bioethical aspects related to in-hospital management of the health crisis</measure>
    <time_frame>10 months</time_frame>
    <description>Through structured interviews, data collection in each epidemiological period, and evaluation of the application of recommended measures from the bioethical point of view, a comparative study will be carried out between hospitals, taking into account the use of resources and analyzing the situations of ethical commitment for healthcare professionals, patients and institutions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analysis of the spectrum of mutants of SARS-CoV-2 and its possible association with the clinical evolution of COVID-19</measure>
    <time_frame>6 months</time_frame>
    <description>From the mass sequencing of SARS-CoV-2 and the calculation of viral variability indices, it will be studied whether or not there is an association between the spectrum of viral mutants and clinical evolution</description>
  </primary_outcome>
  <enrollment type="Actual">1000</enrollment>
  <condition>Covid19</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      SARS-CoV-2&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with confirmed diagnosis of COVID-19 (positive RT-PCR for SARS-CoV-2 in&#xD;
        respiratory sample) will from the following university hospitals, will be enrolled for the&#xD;
        study:&#xD;
&#xD;
        Hospital Universitario 12 de Octubre, Hospital Universitario Fundación Jiménez Díaz,&#xD;
        Hospital Universitario Infanta Elena, Hospital Clínico Universtario Virgen de la Arrixaca&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of COVID-19 (positive RT-PCR for SARS-CoV-2 in respiratory&#xD;
             sample).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspected coronavirus infection without diagnostic confirmation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fundacion Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</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 7, 2020</last_update_submitted>
  <last_update_submitted_qc>August 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>genomics</keyword>
  <keyword>bioethics</keyword>
  <keyword>SARS-CoV-2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- 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/NCT04505709
org study id: STOP-Coronavirus
secondary id: COV20/00181
nct id: NCT04505709
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The STOP-Coronavirus project is an integrated and multidisciplinary study that aims to
      analyze the impact that various factors have on the evolution and prognosis of the current
      COVID-19. Clinical presentation, immunological markers, therapeutic strategies, host and
      virus genomics, and bioethical considerations will be analyzed with a prospective multicenter
      cohort of patients with a diagnosis of COVID-19.
This project led my Dr Aguado Garcia, has established 8 Work Parckages (WP) to analyze
      factors involved in the impact of COVID-19. WP that correspond to University Hospital
      Fundacion Jimenez Diaz are described in this register across different objectives:

      WP 3 (Dr Ayuso García) is aimed to analyze the genetic markers of host susceptibility
      associated with clinical evolution of COVID-19.

      WP 6 (Dr Ruiz Hornillos) will study the socio-economic and bioethical repercussions of
      COVID-19.

      WP 7 (Dr Perales) will analyze the complexity of the spectrum of SARS-CoV-2 mutants and their
      possible association with the evolutionary course of COVID-19

      This project will guide and individualize the clinical and therapeutic approach to COVID-19
      and mitigate the health and social impact of the pandemic.
observational model: Cohort
time perspective: Prospective
measure: Identification of host genetic markers associated with the evolution of COVID-19
time frame: 4 months
description: Based on the cohort of patients with a confirmed diagnosis of COVID-19 and according to severity categories, a Genome-wide association study (GWAS) will be carried out
measure: Analysis of bioethical aspects related to in-hospital management of the health crisis
time frame: 10 months
description: Through structured interviews, data collection in each epidemiological period, and evaluation of the application of recommended measures from the bioethical point of view, a comparative study will be carried out between hospitals, taking into account the use of resources and analyzing the situations of ethical commitment for healthcare professionals, patients and institutions
measure: Analysis of the spectrum of mutants of SARS-CoV-2 and its possible association with the clinical evolution of COVID-19
time frame: 6 months
description: From the mass sequencing of SARS-CoV-2 and the calculation of viral variability indices, it will be studied whether or not there is an association between the spectrum of viral mutants and clinical evolution
SARS-CoV-2
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Months
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
responsible party type: Sponsor
mesh term: COVID-19