<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/NCT04482361</url>
  </required_header>
  <id_info>
    <org_study_id>SEROEPIDEMIOLOGY COVID IN CABA</org_study_id>
    <nct_id>NCT04482361</nct_id>
  </id_info>
  <brief_title>SERO-EPIDEMIOLOGY OF SARS-COV2 INFECTION IN THE AUTONOMOUS CITY OF BUENOS AIRES</brief_title>
  <official_title>SERO-EPIDEMIOLOGY OF SARS-COV2 INFECTION IN THE AUTONOMOUS CITY OF BUENOS AIRES</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ministerio de Salud de Ciudad Autónoma de Buenos Aires</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ministerio de Salud de Ciudad Autónoma de Buenos Aires</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 pandemic of a new coronavirus SARS-COV-2, which causes COVID-19 disease, has spread&#xD;
      rapidly and is a major public health challenge. While the focus is primarily on containing&#xD;
      the number of cases and finding alternative therapies, information is still lacking to&#xD;
      elucidate the dynamics of viral circulation and to understand the distribution of the&#xD;
      infection in the population.&#xD;
&#xD;
      The cases reported in Argentina and worldwide could plausibly represent only a small&#xD;
      proportion of the number of asymptomatic or poorly symptomatic cases that exist in society.&#xD;
      However, the magnitude of this dissociation between symptomatic cases and asymptomatic&#xD;
      persons is unknown.&#xD;
&#xD;
      Knowing this information is of strategic importance as it will allow the estimation of a&#xD;
      community prevalence and the evaluation of the best containment strategy. In fact, although&#xD;
      all social distancing measures are now indispensable, the feasibility of prolonging the&#xD;
      measure over time is a complex issue and in any case will require population-based&#xD;
      information.&#xD;
&#xD;
      The best way to approach the estimation of a true population prevalence is to take&#xD;
      representative samples from the population and test them periodically. These experiences were&#xD;
      carried out in other contexts showing heterogeneous results within the community studied. In&#xD;
      Spain, for example, the range of antibodies present in the population varied from 1.1% to&#xD;
      14.2%, also showing that an important part of the population had had contact with the virus&#xD;
      without symptoms. Studies in Switzerland and the United States also show similar findings.&#xD;
      However, these estimates are not automatically transferable to other settings.&#xD;
&#xD;
      The city of Buenos Aires has a particular demographic composition with an important group of&#xD;
      the population living in shantytowns (it is estimated that between 7% and 10% of the&#xD;
      population lives in shantytowns) and with much heterogeneity among the different communes of&#xD;
      the city. In the villas, the incidence rates of COVID-19 infection differ significantly from&#xD;
      those present in the group &quot;outside the village&quot;. However, there is also an important&#xD;
      difference in the incidence rates by commune, even without considering the villas.&#xD;
&#xD;
      Thus, it is important to know the sero-epidemiology of antibodies against SARS-COV2 in a&#xD;
      representative sample of the city of Buenos Aires.&#xD;
&#xD;
      For this purpose, a nationally produced test (COVIDAR IgG) developed by professionals from&#xD;
      CONICET and Instituto Leloir will be used.&#xD;
&#xD;
      The aim of this initiative is to estimate the true dimension of the COVID-19 epidemic in the&#xD;
      City of Buenos Aires, by studying the immunological status of the Buenos Aires population in&#xD;
      relation to SARS-Cov2, as well as to observe the evolution of the infection among the&#xD;
      population, since this information is essential to guide future public health measures&#xD;
      related to the control of COVID-19.&#xD;
&#xD;
      To achieve this objective, a comprehensive sero-epidemiological study will be carried out to&#xD;
      provide estimates of past SARS-Cov2 infection with sufficient precision to be representative&#xD;
      of the sero-epidemiological status of the Buenos Aires city population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 6, 2020</start_date>
  <completion_date type="Actual">December 22, 2020</completion_date>
  <primary_completion_date type="Actual">December 22, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>4 Months</target_duration>
  <primary_outcome>
    <measure>Prevalence of IGG for COVID-19</measure>
    <time_frame>4 months</time_frame>
    <description>To estimate the prevalence of SARS-Cov2 infection in the city of Buenos Aires, by means of the determination of IGG-type antibodies in a representative and randomized sample of adult residents of the city.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in prevalence of IGG for COVID-19</measure>
    <time_frame>4 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">5900</enrollment>
  <condition>COVID-19</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Presence of specific anti-SARS-CoV-2 antibodies</intervention_name>
    <description>Presence of specific anti-SARS-CoV-2 antibodies</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The present study will be a transversal study carried out on 1,800 people over 18 years of&#xD;
        age resident in CABA for 10 working days, between the months of July and August. The survey&#xD;
        will be repeated in August and September.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 at the time of signing the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ≤17 years old.&#xD;
&#xD;
          -  Declare that currently having confirmed COVID-19 infection.&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Ministerio de Salud de la Ciudad Autónoma de Buenos Aires</name>
      <address>
        <city>Ciudad Autónoma de Buenos Aires</city>
        <zip>1284</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>January 21, 2021</last_update_submitted>
  <last_update_submitted_qc>January 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Seroepidemiology</keyword>
  <keyword>Epidemiology</keyword>
  <keyword>Antibodies</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>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/NCT04482361
org study id: SEROEPIDEMIOLOGY COVID IN CABA
nct id: NCT04482361
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The pandemic of a new coronavirus SARS-COV-2, which causes COVID-19 disease, has spread
      rapidly and is a major public health challenge. While the focus is primarily on containing
      the number of cases and finding alternative therapies, information is still lacking to
      elucidate the dynamics of viral circulation and to understand the distribution of the
      infection in the population.

      The cases reported in Argentina and worldwide could plausibly represent only a small
      proportion of the number of asymptomatic or poorly symptomatic cases that exist in society.
      However, the magnitude of this dissociation between symptomatic cases and asymptomatic
      persons is unknown.

      Knowing this information is of strategic importance as it will allow the estimation of a
      community prevalence and the evaluation of the best containment strategy. In fact, although
      all social distancing measures are now indispensable, the feasibility of prolonging the
      measure over time is a complex issue and in any case will require population-based
      information.

      The best way to approach the estimation of a true population prevalence is to take
      representative samples from the population and test them periodically. These experiences were
      carried out in other contexts showing heterogeneous results within the community studied. In
      Spain, for example, the range of antibodies present in the population varied from 1.1% to
      14.2%, also showing that an important part of the population had had contact with the virus
      without symptoms. Studies in Switzerland and the United States also show similar findings.
      However, these estimates are not automatically transferable to other settings.

      The city of Buenos Aires has a particular demographic composition with an important group of
      the population living in shantytowns (it is estimated that between 7% and 10% of the
      population lives in shantytowns) and with much heterogeneity among the different communes of
      the city. In the villas, the incidence rates of COVID-19 infection differ significantly from
      those present in the group "outside the village". However, there is also an important
      difference in the incidence rates by commune, even without considering the villas.

      Thus, it is important to know the sero-epidemiology of antibodies against SARS-COV2 in a
      representative sample of the city of Buenos Aires.

      For this purpose, a nationally produced test (COVIDAR IgG) developed by professionals from
      CONICET and Instituto Leloir will be used.

      The aim of this initiative is to estimate the true dimension of the COVID-19 epidemic in the
      City of Buenos Aires, by studying the immunological status of the Buenos Aires population in
      relation to SARS-Cov2, as well as to observe the evolution of the infection among the
      population, since this information is essential to guide future public health measures
      related to the control of COVID-19.

      To achieve this objective, a comprehensive sero-epidemiological study will be carried out to
      provide estimates of past SARS-Cov2 infection with sufficient precision to be representative
      of the sero-epidemiological status of the Buenos Aires city population.
observational model: Ecologic or Community
time perspective: Prospective
measure: Prevalence of IGG for COVID-19
time frame: 4 months
description: To estimate the prevalence of SARS-Cov2 infection in the city of Buenos Aires, by means of the determination of IGG-type antibodies in a representative and randomized sample of adult residents of the city.
measure: Changes in prevalence of IGG for COVID-19
time frame: 4 months
intervention type: Diagnostic Test
intervention name: Presence of specific anti-SARS-CoV-2 antibodies
description: Presence of specific anti-SARS-CoV-2 antibodies
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: Argentina
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Antibodies
sharing ipd: No