<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/NCT04408014</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-19-Epi-01</org_study_id>
    <nct_id>NCT04408014</nct_id>
  </id_info>
  <brief_title>Seroepidemiological Study of SARS-CoV-2 (COVID-19) Infection in Population Subgroups in the State of São Paulo</brief_title>
  <official_title>Seroepidemiological Study of SARS-CoV-2 Infection in Population Subgroups in the State of São Paulo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Butantan Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Butantan Institute</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>
      Seroepidemiological Study of SARS-CoV-2 Infection in Population Subgroups in the State of São&#xD;
      Paulo&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a cross-sectional study to estimate the prevalence of antibodies against SARS-CoV-2&#xD;
      is different population subgroups in the State of São Paulo&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">July 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of antibodies against SARS-CoV-2 through serological testing</measure>
    <time_frame>1 month</time_frame>
    <description>IgM and IgG antibodies against SARS-CoV-2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of participants with a positive RT-PCR test result for SARS-CoV-2</measure>
    <time_frame>1 month</time_frame>
    <description>Positive RT-PCR test result for SARS-CoV-2</description>
  </primary_outcome>
  <number_of_groups>8</number_of_groups>
  <enrollment type="Anticipated">18901</enrollment>
  <condition>COVID</condition>
  <condition>SARS-CoV 2</condition>
  <arm_group>
    <arm_group_label>HC-USP</arm_group_label>
    <description>Home contacts of health professionals diagnosed with COVID-19 at the Hospital of Clínic of Medicine School of the University of São Paulo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CORAS</arm_group_label>
    <description>Refugees living in the city of São Paulo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hemocenter</arm_group_label>
    <description>Blood Donors of the Pró-Sangue Hemocenter Foundation of São Paulo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CPP - Butantan Penitentiary Progression Center</arm_group_label>
    <description>Participants of the CPP - Butantan Penitentiary Progression Center</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHSP - Penitentiary System Hospital Center</arm_group_label>
    <description>Participants of the CHSP - Penitentiary System Hospital Center</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SABE (Health, Wellness and Aging)</arm_group_label>
    <description>Participants of the SABE Project (Health, Wellness and Aging)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ILPI - Long-Term Care Institution for the Elderly</arm_group_label>
    <description>Residents of the Long-Term Care Institution for the Elderly of Botucatu</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ICR-USP - Children's Institute of HCFMUSP</arm_group_label>
    <description>Home contacts of children and adolescents diagnosed with COVID-19, attended at the Children's Institute of HCFMUSP</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Serological test</intervention_name>
    <description>IgM and IgG for SARS-CoV-2</description>
    <arm_group_label>CHSP - Penitentiary System Hospital Center</arm_group_label>
    <arm_group_label>CORAS</arm_group_label>
    <arm_group_label>CPP - Butantan Penitentiary Progression Center</arm_group_label>
    <arm_group_label>HC-USP</arm_group_label>
    <arm_group_label>Hemocenter</arm_group_label>
    <arm_group_label>ICR-USP - Children's Institute of HCFMUSP</arm_group_label>
    <arm_group_label>ILPI - Long-Term Care Institution for the Elderly</arm_group_label>
    <arm_group_label>SABE (Health, Wellness and Aging)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Nasopharyngeal Swab</intervention_name>
    <description>PCR for SARS-CoV-2</description>
    <arm_group_label>CHSP - Penitentiary System Hospital Center</arm_group_label>
    <arm_group_label>CORAS</arm_group_label>
    <arm_group_label>CPP - Butantan Penitentiary Progression Center</arm_group_label>
    <arm_group_label>HC-USP</arm_group_label>
    <arm_group_label>ICR-USP - Children's Institute of HCFMUSP</arm_group_label>
    <arm_group_label>ILPI - Long-Term Care Institution for the Elderly</arm_group_label>
    <arm_group_label>SABE (Health, Wellness and Aging)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Oropharyngeal Swab</intervention_name>
    <description>PCR for SARS-CoV-2</description>
    <arm_group_label>CHSP - Penitentiary System Hospital Center</arm_group_label>
    <arm_group_label>CORAS</arm_group_label>
    <arm_group_label>CPP - Butantan Penitentiary Progression Center</arm_group_label>
    <arm_group_label>HC-USP</arm_group_label>
    <arm_group_label>ICR-USP - Children's Institute of HCFMUSP</arm_group_label>
    <arm_group_label>ILPI - Long-Term Care Institution for the Elderly</arm_group_label>
    <arm_group_label>SABE (Health, Wellness and Aging)</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Nasopharyngeal Swab, Oropharyngeal Swab and Blood Samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        -  Home contacts of health professionals at the Hospital das Clínicas of the Medical&#xD;
             School of USP diagnosed with COVID-19;&#xD;
&#xD;
          -  Refugees living in the city of São Paulo - CORAS-BR Project;&#xD;
&#xD;
          -  Blood Donors of the Fundação Pró-Sangue Hemocentro de São Paulo&#xD;
&#xD;
          -  Butantan Penitentiary Progression Center participants;&#xD;
&#xD;
          -  Penitentiary System Hospital Center (CHSP) participants;&#xD;
&#xD;
          -  SABE Project - Cohort of the Elderly in the city of São Paulo and their home contacts;&#xD;
&#xD;
          -  Residents of the Long Term Care Institution (ILPI) of Botucatu;&#xD;
&#xD;
          -  Home contacts of children and adolescents with a positive diagnosis for COVID-19,&#xD;
             attended at Instituto da Criança, HCFMUSP.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All potential volunteers invited to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All potential eligible participants, but who do not show interest in participating in&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexander R Precioso, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Instituto butantan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alexander R Precioso, MD, PhD</last_name>
    <phone>+55 11 3723-2121</phone>
    <email>alexander.precioso@butantan.gov.br</email>
  </overall_contact>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 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>
  </condition_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/NCT04408014
org study id: COVID-19-Epi-01
nct id: NCT04408014
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Seroepidemiological Study of SARS-CoV-2 Infection in Population Subgroups in the State of São
      Paulo
This is a cross-sectional study to estimate the prevalence of antibodies against SARS-CoV-2
      is different population subgroups in the State of São Paulo
observational model: Other
time perspective: Cross-Sectional
measure: Prevalence of antibodies against SARS-CoV-2 through serological testing
time frame: 1 month
description: IgM and IgG antibodies against SARS-CoV-2
measure: Frequency of participants with a positive RT-PCR test result for SARS-CoV-2
time frame: 1 month
description: Positive RT-PCR test result for SARS-CoV-2
arm group label: HC-USP
description: Home contacts of health professionals diagnosed with COVID-19 at the Hospital of Clínic of Medicine School of the University of São Paulo
arm group label: CORAS
description: Refugees living in the city of São Paulo
arm group label: Hemocenter
description: Blood Donors of the Pró-Sangue Hemocenter Foundation of São Paulo
arm group label: CPP - Butantan Penitentiary Progression Center
description: Participants of the CPP - Butantan Penitentiary Progression Center
arm group label: CHSP - Penitentiary System Hospital Center
description: Participants of the CHSP - Penitentiary System Hospital Center
arm group label: SABE (Health, Wellness and Aging)
description: Participants of the SABE Project (Health, Wellness and Aging)
arm group label: ILPI - Long-Term Care Institution for the Elderly
description: Residents of the Long-Term Care Institution for the Elderly of Botucatu
arm group label: ICR-USP - Children's Institute of HCFMUSP
description: Home contacts of children and adolescents diagnosed with COVID-19, attended at the Children's Institute of HCFMUSP
intervention type: Diagnostic Test
intervention name: Serological test
description: IgM and IgG for SARS-CoV-2
arm group label: CHSP - Penitentiary System Hospital Center
arm group label: CORAS
arm group label: CPP - Butantan Penitentiary Progression Center
arm group label: HC-USP
arm group label: Hemocenter
arm group label: ICR-USP - Children's Institute of HCFMUSP
arm group label: ILPI - Long-Term Care Institution for the Elderly
arm group label: SABE (Health, Wellness and Aging)
intervention type: Diagnostic Test
intervention name: Nasopharyngeal Swab
description: PCR for SARS-CoV-2
arm group label: CHSP - Penitentiary System Hospital Center
arm group label: CORAS
arm group label: CPP - Butantan Penitentiary Progression Center
arm group label: HC-USP
arm group label: ICR-USP - Children's Institute of HCFMUSP
arm group label: ILPI - Long-Term Care Institution for the Elderly
arm group label: SABE (Health, Wellness and Aging)
intervention type: Diagnostic Test
intervention name: Oropharyngeal Swab
description: PCR for SARS-CoV-2
arm group label: CHSP - Penitentiary System Hospital Center
arm group label: CORAS
arm group label: CPP - Butantan Penitentiary Progression Center
arm group label: HC-USP
arm group label: ICR-USP - Children's Institute of HCFMUSP
arm group label: ILPI - Long-Term Care Institution for the Elderly
arm group label: SABE (Health, Wellness and Aging)
Nasopharyngeal Swab, Oropharyngeal Swab and Blood Samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alexander R Precioso, MD, PhD
role: Study Chair
affiliation: Instituto butantan
last name: Alexander R Precioso, MD, PhD
phone: +55 11 3723-2121
email: alexander.precioso@butantan.gov.br
responsible party type: Sponsor
mesh term: Infections
sharing ipd: No