<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/NCT04473183</url>
  </required_header>
  <id_info>
    <org_study_id>SURG-2020-28863</org_study_id>
    <nct_id>NCT04473183</nct_id>
  </id_info>
  <brief_title>Epidemiologic Assessment of SARS-CoV-2 (COVID-19) Prevalence in Minnesota</brief_title>
  <official_title>Epidemiologic Assessment of SARS-CoV-2 Prevalence in Minnesota</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</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 purpose of this epidemiologic study is to estimate the prevalence and incidence of&#xD;
      anti-SARS-CoV-2 antibodies in at-risk, exposed, affected populations. The study will also&#xD;
      estimate the risk of SARS-CoV-2 exposure in target population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is not for real-time diagnostic purposes, guidance for patient care, or the&#xD;
      development of a diagnostic test. The research tests performed for this study will not be&#xD;
      prioritized over clinical care samples, that research samples will be batched and tested&#xD;
      after clinical care samples. This study is a population-based epidemiologic analysis of&#xD;
      prevalence of various groups of persons.&#xD;
&#xD;
      Group (1) general healthy population. People 18 years of age and older that have not tested&#xD;
      positive for SARS-CoV-2 and who have not sought medical help in the previous 4 months.&#xD;
&#xD;
      Group (2) Medical School Residents , 18 years of age and older that have not tested positive&#xD;
      for SARS-CoV-2 Group (3) Individuals who are HIV positive. People 18 years of age and older&#xD;
      that have not tested positive for SARS-CoV-2&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI left the University, and the study was not funded.&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 21, 2020</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2022</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Prevalence of Symptomatic Infection</measure>
    <time_frame>1 year</time_frame>
    <description>Prevalence of symptomatic infection will be reported as the percent of participants in each group who test positive for SARS-CoV-2 infection and self-report symptoms of SARS-CoV-2 infection.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of Subclinical Infection</measure>
    <time_frame>1 year</time_frame>
    <description>Prevalence of subclinical infection will be reported as the percent of participants in each group who test positive for SARS-CoV-2 infection and self-report no symptoms of SARS-CoV-2 infection.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Covid19</condition>
  <condition>SARS-CoV Infection</condition>
  <condition>SARS-CoV-2</condition>
  <condition>Corona Virus Infection</condition>
  <arm_group>
    <arm_group_label>General Healthy Population</arm_group_label>
    <description>Participants in this group are part of the general healthy population of adults 18 years-of-age and older, not known to be exposed to the virus as reported by potential participants and who have not sought medical help in the previous 4 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medical School Residents</arm_group_label>
    <description>Participants in this group are medical school residents.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Individuals who are HIV positive</arm_group_label>
    <description>Participants in this group are HIV positive.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Specimen Collection</intervention_name>
    <description>Blood: Two tubes of blood (up to 10 ml each) will be drawn from participants and will be collected by experienced phlebotomists.&#xD;
Nasal, oral, and rectal swabs: Nasal, oral, and rectal swabs are optional specimens that patients may be asked to donate. If prospective consent is provided, swabs will be self-collected by participants after receiving clear instructions from the team and collected in the dedicated container.&#xD;
Saliva: Saliva is an optional specimen that patients may be asked to donate. If prospective consent is provided, whole saliva samples will be self-collected by participants using a pad placed between the cheek and gum for 2-5 minutes or collecting the saliva directly to a sterile container.</description>
    <arm_group_label>General Healthy Population</arm_group_label>
    <arm_group_label>Individuals who are HIV positive</arm_group_label>
    <arm_group_label>Medical School Residents</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Surveys</intervention_name>
    <description>Participants will be asked to fill out a brief online survey that will investigate symptoms consistent with SARS-CoV-2 infection in the past 3 months and the geographic location of the clinic(s) they work in (if a resident of a medical school) and their comorbidities related to SARS-CoV-2.</description>
    <arm_group_label>General Healthy Population</arm_group_label>
    <arm_group_label>Individuals who are HIV positive</arm_group_label>
    <arm_group_label>Medical School Residents</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      With the participant's approval, and as approved by IRB, de-identified biological samples&#xD;
      will be stored and tested for anti- SARS-CoV-2 IgG and IgM. These samples may be used in&#xD;
      future COVID-19 studies to develop assays or study other features of the disease. These&#xD;
      leftovers may be used for multiple basic science analysis and potentially for genetic&#xD;
      testing. The consent process will explain this to prospective participants.&#xD;
&#xD;
      During the conduct of the study, an individual participant can choose to withdraw consent to&#xD;
      have biological specimens stored for future research. However, withdrawal of consent with&#xD;
      regard to biosample storage will not be possible after the study is completed. The consent&#xD;
      process will explain this to prospective participants.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Group 1 are members of general healthy population. Group 2 are medical residents. Group 3&#xD;
        are individuals who test positive for HIV infection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants in Group 1 (General Healthy Population) must have no known exposure to&#xD;
             SARS-CoV-2 and have not sought medical help in the previous 4 months for&#xD;
             SARS-CoV-2-related symptoms&#xD;
&#xD;
          -  Participants in Group 2 must be currently enrolled in a medical residency program&#xD;
&#xD;
          -  Participants in Group 3 must currently test positive for HIV infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of a condition or abnormality that in the opinion of the Investigator would&#xD;
             compromise the safety of the participant or the quality of the data (e.g., someone not&#xD;
             able to answer the questionnaire because of a psychological condition or an anxiety&#xD;
             disorder that is severe).&#xD;
&#xD;
          -  Contraindication for routine blood draws (e.g., severe anemia, hemophilia, etc)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luca Schifanella, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>August 11, 2022</last_update_submitted>
  <last_update_submitted_qc>August 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2022</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>
    <mesh_term>Coronavirus Infections</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/NCT04473183
org study id: SURG-2020-28863
nct id: NCT04473183
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this epidemiologic study is to estimate the prevalence and incidence of
      anti-SARS-CoV-2 antibodies in at-risk, exposed, affected populations. The study will also
      estimate the risk of SARS-CoV-2 exposure in target population.
This study is not for real-time diagnostic purposes, guidance for patient care, or the
      development of a diagnostic test. The research tests performed for this study will not be
      prioritized over clinical care samples, that research samples will be batched and tested
      after clinical care samples. This study is a population-based epidemiologic analysis of
      prevalence of various groups of persons.

      Group (1) general healthy population. People 18 years of age and older that have not tested
      positive for SARS-CoV-2 and who have not sought medical help in the previous 4 months.

      Group (2) Medical School Residents , 18 years of age and older that have not tested positive
      for SARS-CoV-2 Group (3) Individuals who are HIV positive. People 18 years of age and older
      that have not tested positive for SARS-CoV-2
observational model: Cohort
time perspective: Prospective
measure: Prevalence of Symptomatic Infection
time frame: 1 year
description: Prevalence of symptomatic infection will be reported as the percent of participants in each group who test positive for SARS-CoV-2 infection and self-report symptoms of SARS-CoV-2 infection.
measure: Prevalence of Subclinical Infection
time frame: 1 year
description: Prevalence of subclinical infection will be reported as the percent of participants in each group who test positive for SARS-CoV-2 infection and self-report no symptoms of SARS-CoV-2 infection.
arm group label: General Healthy Population
description: Participants in this group are part of the general healthy population of adults 18 years-of-age and older, not known to be exposed to the virus as reported by potential participants and who have not sought medical help in the previous 4 months.
arm group label: Medical School Residents
description: Participants in this group are medical school residents.
arm group label: Individuals who are HIV positive
description: Participants in this group are HIV positive.
intervention type: Diagnostic Test
intervention name: Specimen Collection
description: Blood: Two tubes of blood (up to 10 ml each) will be drawn from participants and will be collected by experienced phlebotomists.
Nasal, oral, and rectal swabs: Nasal, oral, and rectal swabs are optional specimens that patients may be asked to donate. If prospective consent is provided, swabs will be self-collected by participants after receiving clear instructions from the team and collected in the dedicated container.
Saliva: Saliva is an optional specimen that patients may be asked to donate. If prospective consent is provided, whole saliva samples will be self-collected by participants using a pad placed between the cheek and gum for 2-5 minutes or collecting the saliva directly to a sterile container.
arm group label: General Healthy Population
arm group label: Individuals who are HIV positive
arm group label: Medical School Residents
intervention type: Diagnostic Test
intervention name: Surveys
description: Participants will be asked to fill out a brief online survey that will investigate symptoms consistent with SARS-CoV-2 infection in the past 3 months and the geographic location of the clinic(s) they work in (if a resident of a medical school) and their comorbidities related to SARS-CoV-2.
arm group label: General Healthy Population
arm group label: Individuals who are HIV positive
arm group label: Medical School Residents
With the participant's approval, and as approved by IRB, de-identified biological samples
      will be stored and tested for anti- SARS-CoV-2 IgG and IgM. These samples may be used in
      future COVID-19 studies to develop assays or study other features of the disease. These
      leftovers may be used for multiple basic science analysis and potentially for genetic
      testing. The consent process will explain this to prospective participants.

      During the conduct of the study, an individual participant can choose to withdraw consent to
      have biological specimens stored for future research. However, withdrawal of consent with
      regard to biosample storage will not be possible after the study is completed. The consent
      process will explain this to prospective participants.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Luca Schifanella, MD, PhD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Severe Acute Respiratory Syndrome
sharing ipd: Undecided