<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/NCT04479488</url>
  </required_header>
  <id_info>
    <org_study_id>30047620.3.0000.0071</org_study_id>
    <nct_id>NCT04479488</nct_id>
  </id_info>
  <brief_title>Brazilian Registry for Clinical Presentation of Individuals With COVID-19 (SARS-Brazil)</brief_title>
  <acronym>SARS-Brazil</acronym>
  <official_title>Brazilian COVID-19 Registry for Clinical Presentation of Individuals With COVID-19: a National, Multicentre, Prospective Observational Study (SARS-Brazil)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Israelita Albert Einstein</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Brazil</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Israelita Albert Einstein</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>
      This is a registry-based cohort study of all adult patients (≥18 years) with confirmed or&#xD;
      suspected SARS-CoV-2 infection.&#xD;
&#xD;
      The main goal is to describe mortality incidence, demographic characteristics, coexisting&#xD;
      conditions, treatments, outcomes among SARS-CoV2 infected patients.&#xD;
&#xD;
      A secondary goal is to identify biological factors (OMICS - genomic, proteomic and&#xD;
      metabolomics characterization) associated with severity conditions for these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Registry on characteristics and outcomes of hospitalized and non-hospitalized SARS-CoV2&#xD;
      infected patients in Brazil.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Actual">December 30, 2022</completion_date>
  <primary_completion_date type="Actual">March 30, 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>2 Months</target_duration>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>60 Days</time_frame>
    <description>All-cause mortality rates at 60 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence and course of symptoms of COVID-19 infection</measure>
    <time_frame>60 Days</time_frame>
    <description>To assess the prevalence and course of symptoms of COVID-19 infection of patients followed during a period of 60 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalizations</measure>
    <time_frame>60 Days</time_frame>
    <description>Rate of patients requiring hospitalization and re-hospitalization (readmission to the hospital occurring within 60 days after admission)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen supplementation</measure>
    <time_frame>60 Days</time_frame>
    <description>Rate of patients requiring oxygen therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of invasive mechanical ventilation</measure>
    <time_frame>60 Days</time_frame>
    <description>Rate of patients requiring invasive mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive care unit length of stay</measure>
    <time_frame>60 Days</time_frame>
    <description>ICU length of stay</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Serum proteomic</measure>
    <time_frame>60 Days</time_frame>
    <description>Percentual changes in serum proteome of patients with mild or moderate to severe disease</description>
  </other_outcome>
  <other_outcome>
    <measure>Serum metabolomic</measure>
    <time_frame>60 Days</time_frame>
    <description>Percentual changes in serum metabolome of patients with mild or moderate to severe disease</description>
  </other_outcome>
  <other_outcome>
    <measure>Genomic description</measure>
    <time_frame>60 Days</time_frame>
    <description>Determination of whole genome sequence and transcriptomic of mild or moderate to severe disease</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1587</enrollment>
  <condition>Covid19</condition>
  <condition>SARS-CoV Infection</condition>
  <arm_group>
    <arm_group_label>Hospitalized patients</arm_group_label>
    <description>Patient who are suspected or confirmed SARS-CoV2 infection need hospitalization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-hospitalized patients</arm_group_label>
    <description>Patient who are suspected or confirmed SARS-CoV2 infection non-hospitalized.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hospital admission</intervention_name>
    <description>Usual care.</description>
    <arm_group_label>Hospitalized patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-hospitalization procedures</intervention_name>
    <description>Usual care.</description>
    <arm_group_label>Non-hospitalized patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, serum, plasma and nasal swab&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        SARS-Brazil Registry is designed as multicenter observational cohort of adult patients (≥18&#xD;
        years old), that are confirmed or suspected SARS-CoV-2 infection in Brazilian hospitals.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (≥18 years);&#xD;
&#xD;
          -  Confirmed or suspected SARS-CoV2 infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who expressed opposition to participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Otávio Berwanger, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Israelita Albert Einstein</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Henrique A Fonseca, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Israelita Albert Einstein</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Emergencia Dr. Daniel Houly</name>
      <address>
        <city>Arapiraca</city>
        <state>Alagoas</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade Federal da Bahia</name>
      <address>
        <city>Vitória Da Conquista</city>
        <state>Bahia</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alencar Serviços Médicos Ltda</name>
      <address>
        <city>Barbalha</city>
        <state>Ceará</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Estadual Jayme dos Santos Neves</name>
      <address>
        <city>Serra</city>
        <state>Espirito Santo</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Rita de Cássia</name>
      <address>
        <city>Vitória</city>
        <state>Espirito Santo</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundação Educacional Lucas Machado</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundação Hopitalar São Francisco de Assis</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Lucia</name>
      <address>
        <city>Poços De Caldas</city>
        <state>Minas Gerais</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Giselda Trigueiro</name>
      <address>
        <city>Natal</city>
        <state>Rio Grande Do Norte</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital São Vicente de Paulo</name>
      <address>
        <city>Passo Fundo</city>
        <state>Rio Grande Do Sul</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Casa de Votuporanga</name>
      <address>
        <city>Votuporanga</city>
        <state>São Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Municipal Vila Santa Catarina</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital São Camilo - Ipiranga</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital São Camilo - Pompéia</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>March 8, 2023</last_update_submitted>
  <last_update_submitted_qc>March 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV2 infection</keyword>
  <keyword>Intensive care unit</keyword>
  <keyword>Oxygen supplementation</keyword>
  <keyword>Invasive ventilation</keyword>
  <keyword>Mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Severe Acute Respiratory Syndrome</mesh_term>
  </condition_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/NCT04479488
org study id: 30047620.3.0000.0071
nct id: NCT04479488
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a registry-based cohort study of all adult patients (≥18 years) with confirmed or
      suspected SARS-CoV-2 infection.

      The main goal is to describe mortality incidence, demographic characteristics, coexisting
      conditions, treatments, outcomes among SARS-CoV2 infected patients.

      A secondary goal is to identify biological factors (OMICS - genomic, proteomic and
      metabolomics characterization) associated with severity conditions for these patients.
Registry on characteristics and outcomes of hospitalized and non-hospitalized SARS-CoV2
      infected patients in Brazil.
observational model: Cohort
time perspective: Prospective
measure: All-cause mortality
time frame: 60 Days
description: All-cause mortality rates at 60 days
measure: Incidence and course of symptoms of COVID-19 infection
time frame: 60 Days
description: To assess the prevalence and course of symptoms of COVID-19 infection of patients followed during a period of 60 days
measure: Hospitalizations
time frame: 60 Days
description: Rate of patients requiring hospitalization and re-hospitalization (readmission to the hospital occurring within 60 days after admission)
measure: Oxygen supplementation
time frame: 60 Days
description: Rate of patients requiring oxygen therapy
measure: Use of invasive mechanical ventilation
time frame: 60 Days
description: Rate of patients requiring invasive mechanical ventilation
measure: Intensive care unit length of stay
time frame: 60 Days
description: ICU length of stay
measure: Serum proteomic
time frame: 60 Days
description: Percentual changes in serum proteome of patients with mild or moderate to severe disease
measure: Serum metabolomic
time frame: 60 Days
description: Percentual changes in serum metabolome of patients with mild or moderate to severe disease
measure: Genomic description
time frame: 60 Days
description: Determination of whole genome sequence and transcriptomic of mild or moderate to severe disease
arm group label: Hospitalized patients
description: Patient who are suspected or confirmed SARS-CoV2 infection need hospitalization.
arm group label: Non-hospitalized patients
description: Patient who are suspected or confirmed SARS-CoV2 infection non-hospitalized.
intervention type: Other
intervention name: Hospital admission
description: Usual care.
arm group label: Hospitalized patients
intervention type: Other
intervention name: Non-hospitalization procedures
description: Usual care.
arm group label: Non-hospitalized patients
Blood, serum, plasma and nasal swab
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Otávio Berwanger, PhD
role: Study Director
affiliation: Hospital Israelita Albert Einstein
last name: Henrique A Fonseca, PhD
role: Principal Investigator
affiliation: Hospital Israelita Albert Einstein
facility: 
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country: Brazil
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Severe Acute Respiratory Syndrome
sharing ipd: Undecided