<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/NCT04466462</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-Hosp</org_study_id>
    <nct_id>NCT04466462</nct_id>
  </id_info>
  <brief_title>Cross-sectional Study of COVID-19 Infection in Hospital Health Personnel</brief_title>
  <official_title>Cross-sectional Study of COVID-19 Infection in Hospital Health Personnel</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to determine the percentage of past SARS-CoV-2 infections in&#xD;
      hospital health personnel involved in the care of people with COVID-19 in HUGTiP and in&#xD;
      Badalona Serveis Assistencials de Badalona.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Health personnel, especially hospital workers, have been a group especially affected by the&#xD;
      COVID-19 epidemic. According to data from the Ministry of Health, in Spain 26% of health&#xD;
      personnel have been infected by COVID-19, for a total of 31,053 professionals, representing&#xD;
      up to 18.5% of all infections in the Spanish state, with variations between the different&#xD;
      autonomous communities.1 In Italy it was estimated that up to 20% of health workers who&#xD;
      responded to the epidemic would have been infected within a month.&#xD;
&#xD;
      There are no unified guidelines at the state level to determine infection prevention&#xD;
      strategies in health personnel in order to validate them, beyond the use of Personal&#xD;
      Protective Equipment (PPE) in personnel and general strategies for isolation and prevention&#xD;
      of transmission.&#xD;
&#xD;
      There are no approved drug prevention strategies for primary prophylaxis against COVID-19.&#xD;
&#xD;
      Currently, there are no universal mass screening strategies (virological or immunological) to&#xD;
      estimate the actual number of health personnel with an asymptomatic infection, as well as to&#xD;
      determine the percentage of personnel who have already passed the infection asymptomatically&#xD;
      or to determine the percentage of personnel A healthcare provider who has developed some form&#xD;
      of immunity following a confirmed COVID-19 infection.&#xD;
&#xD;
      The HUGTiP, like the rest of Catalan hospitals, has suffered a massive avalanche accumulated&#xD;
      in the time of admission by COVID-19, which has forced it to adopt different innovative&#xD;
      strategies to visit them in emergencies, enter them in conventional hospitalization in a&#xD;
      conventional plant, or attend them in the intensive care units that had to be created de novo&#xD;
      against the clock. As of April 20, 2020, 1,000 hospital discharges have been granted to&#xD;
      patients admitted by COVID-19 in conventional hospitalization plants and 170 more discharges&#xD;
      from those admitted to intensive care units at HUGTiP. Likewise, the Municipal Hospital of&#xD;
      Badalona has given a total of 300 discharges of patients with COVID-19, and they have also&#xD;
      reported about 180 infections in their health personnel in this period.&#xD;
&#xD;
      Due to the high transmission rate of SARS-CoV-2 and its potential severity, several&#xD;
      healthcare workers at HUGTiP decided on their own to take empirical primary prophylaxis with&#xD;
      oral hydroxychloroquine individually as prevention of SARS-CoV-2 infection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 26, 2020</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with past SARS-CoV-2 infection</measure>
    <time_frame>Day 0</time_frame>
    <description>Number of participants with past SARS-CoV-2 infection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of infections in health personnel who have taken voluntary hydroxychloroquine as a prevention strategy for COVID-19 infection</measure>
    <time_frame>Day 0</time_frame>
    <description>Number of infections in health personnel who have taken voluntary hydroxychloroquine as a prevention strategy for COVID-19 infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of infections in health personnel based on the degree of exposure to patients infected with COVID-19.</measure>
    <time_frame>Day 0</time_frame>
    <description>Number of infections in health personnel based on the degree of exposure to patients infected with COVID-19.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of infected participants who are active smokers and/or have chronic lung disease and/ or have history of hypertension.Relationship of degree of exposure to participants infected with SARS-CoV-2 admitted to the hospital.Professional category.</measure>
    <time_frame>Day 0</time_frame>
    <description>Number of infected participants who are active smokers and/or have chronic lung disease and/ or have history of hypertension.Relationship of degree of exposure to participants infected with SARS-CoV-2 admitted to the hospital.Professional category.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants infected with SARS-CoV-2 that presented symptoms and their grade. Number of participants infected with SARS-CoV-2 who required hospitalization. Number of participants infected with SARS-CoV-2 who received treatment.</measure>
    <time_frame>Day 0</time_frame>
    <description>Number of participants infected with SARS-CoV-2 that presented symptoms and their grade.&#xD;
Number of participants infected with SARS-CoV-2 who required hospitalization. Number of participants infected with SARS-CoV-2 who received treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of family members infected from each participant with SARS-CoV-2 infection</measure>
    <time_frame>Day 0</time_frame>
    <description>Number of family members infected from each participant with SARS-CoV-2 infection</description>
  </secondary_outcome>
  <enrollment type="Actual">1000</enrollment>
  <condition>SARS-CoV-2 Infection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        - Adults (age&gt; 18 years) who have worked during the epidemic period (March and April 2020)&#xD;
        in the Infectious Diseases, Pneumology, Emergencies, ICU and Internal Medicine departments&#xD;
        of HUGTiP, or in the Internal Medicine or Emergency departments of the Badalona Municipal&#xD;
        Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (age&gt; 18 years) who have worked during the epidemic period (March and April&#xD;
             2020) in the Infectious Diseases, Pneumology, Emergencies, ICU and Internal Medicine&#xD;
             departments of HUGTiP, or in the Internal Medicine or Emergency departments of the&#xD;
             Badalona Municipal Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation will be voluntary and no exclusion criteria are established&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Germans Trias i Pujol Hospital</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Municipal de Badalona</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <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/NCT04466462
org study id: COVID-Hosp
nct id: NCT04466462
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of the study is to determine the percentage of past SARS-CoV-2 infections in
      hospital health personnel involved in the care of people with COVID-19 in HUGTiP and in
      Badalona Serveis Assistencials de Badalona.
Health personnel, especially hospital workers, have been a group especially affected by the
      COVID-19 epidemic. According to data from the Ministry of Health, in Spain 26% of health
      personnel have been infected by COVID-19, for a total of 31,053 professionals, representing
      up to 18.5% of all infections in the Spanish state, with variations between the different
      autonomous communities.1 In Italy it was estimated that up to 20% of health workers who
      responded to the epidemic would have been infected within a month.

      There are no unified guidelines at the state level to determine infection prevention
      strategies in health personnel in order to validate them, beyond the use of Personal
      Protective Equipment (PPE) in personnel and general strategies for isolation and prevention
      of transmission.

      There are no approved drug prevention strategies for primary prophylaxis against COVID-19.

      Currently, there are no universal mass screening strategies (virological or immunological) to
      estimate the actual number of health personnel with an asymptomatic infection, as well as to
      determine the percentage of personnel who have already passed the infection asymptomatically
      or to determine the percentage of personnel A healthcare provider who has developed some form
      of immunity following a confirmed COVID-19 infection.

      The HUGTiP, like the rest of Catalan hospitals, has suffered a massive avalanche accumulated
      in the time of admission by COVID-19, which has forced it to adopt different innovative
      strategies to visit them in emergencies, enter them in conventional hospitalization in a
      conventional plant, or attend them in the intensive care units that had to be created de novo
      against the clock. As of April 20, 2020, 1,000 hospital discharges have been granted to
      patients admitted by COVID-19 in conventional hospitalization plants and 170 more discharges
      from those admitted to intensive care units at HUGTiP. Likewise, the Municipal Hospital of
      Badalona has given a total of 300 discharges of patients with COVID-19, and they have also
      reported about 180 infections in their health personnel in this period.

      Due to the high transmission rate of SARS-CoV-2 and its potential severity, several
      healthcare workers at HUGTiP decided on their own to take empirical primary prophylaxis with
      oral hydroxychloroquine individually as prevention of SARS-CoV-2 infection.
observational model: Case-Crossover
time perspective: Other
measure: Number of participants with past SARS-CoV-2 infection
time frame: Day 0
description: Number of participants with past SARS-CoV-2 infection
measure: Number of infections in health personnel who have taken voluntary hydroxychloroquine as a prevention strategy for COVID-19 infection
time frame: Day 0
description: Number of infections in health personnel who have taken voluntary hydroxychloroquine as a prevention strategy for COVID-19 infection
measure: Number of infections in health personnel based on the degree of exposure to patients infected with COVID-19.
time frame: Day 0
description: Number of infections in health personnel based on the degree of exposure to patients infected with COVID-19.
measure: Number of infected participants who are active smokers and/or have chronic lung disease and/ or have history of hypertension.Relationship of degree of exposure to participants infected with SARS-CoV-2 admitted to the hospital.Professional category.
time frame: Day 0
description: Number of infected participants who are active smokers and/or have chronic lung disease and/ or have history of hypertension.Relationship of degree of exposure to participants infected with SARS-CoV-2 admitted to the hospital.Professional category.
measure: Number of participants infected with SARS-CoV-2 that presented symptoms and their grade. Number of participants infected with SARS-CoV-2 who required hospitalization. Number of participants infected with SARS-CoV-2 who received treatment.
time frame: Day 0
description: Number of participants infected with SARS-CoV-2 that presented symptoms and their grade.
Number of participants infected with SARS-CoV-2 who required hospitalization. Number of participants infected with SARS-CoV-2 who received treatment.
measure: Number of family members infected from each participant with SARS-CoV-2 infection
time frame: Day 0
description: Number of family members infected from each participant with SARS-CoV-2 infection
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: COVID-19