<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/NCT04445233</url>
  </required_header>
  <id_info>
    <org_study_id>20-0982</org_study_id>
    <secondary_id>550KR242023</secondary_id>
    <nct_id>NCT04445233</nct_id>
  </id_info>
  <brief_title>COVID-19 Household Transmission Study</brief_title>
  <acronym>CO-HOST</acronym>
  <official_title>The COVID-19 Household Transmission Study (CO-HOST) - Epidemiology of SARS-CoV-2 Transmission Within the Household</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>North Carolina Translational and Clinical Sciences Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will test and follow persons quarantined at home after testing positive for&#xD;
      SARS-CoV-2 (COV) aged 18 years and older and their household members aged 1 year and older.&#xD;
&#xD;
      The purpose of this research study is to understand how often COVID-19 (Coronavirus Disease&#xD;
      2019) spreads in the household when someone who tests positive for the virus self-isolates at&#xD;
      home.&#xD;
&#xD;
      The purpose of the extension part of the study is to help us understand long-term immunity to&#xD;
      COVID-19. We are interested in how our immune system might still protect us from COVID-19&#xD;
      even after antibody levels decrease or are no longer detected. We are also interested in how&#xD;
      immunity to COVID-19 is different in kids vs. adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will enroll approximately 200 men and women ≥ 18 years of age who are SARS-CoV-2&#xD;
      PCR positive undergoing home quarantine &amp; approximately 200-1500 immediate household&#xD;
      contacts, both male and female, ≥ 1 year of age.&#xD;
&#xD;
      This study will test and follow persons quarantined at home after testing positive for&#xD;
      SARS-CoV-2 (COV) and their household members.&#xD;
&#xD;
      The CO-HOST mobile nurse initiates a home visit to the home of the COVID-19 index case after&#xD;
      they and their household members (COV-HC) verbally express interest in the study and provide&#xD;
      consent or assent as appropriate. At the first visit, nasopharyngeal (NP) swabs and blood are&#xD;
      collected from COV and all members of the household (COV-HC) to determine infection status.&#xD;
      Additional samples (nasal swabs, saliva, nasal strips), both nurse-collected and&#xD;
      self-collected, may also be collected from COV and COV-HC. The nurse will provide specific&#xD;
      instructions and training on how to perform self-collected swabs.&#xD;
&#xD;
      Every week, thereafter, COV-HC are tested during the 28 days of the study. If home visits are&#xD;
      not possible, then participants will perform self-collected swabs for testing. If COV-HC&#xD;
      develops symptoms, they will be referred per standard of care (SOC).&#xD;
&#xD;
      If COV or COV-HC are hospitalized, they will remain in the study for outcome assessment, but&#xD;
      without further sample collections.&#xD;
&#xD;
      As part of the extension to the study, the study team will come back to previous enrolled&#xD;
      participants' houses for a single visit at about 6 months from when they enrolled in this&#xD;
      study. If these participants prefer, they could come to UNC for this visit instead. At this&#xD;
      visit, the study team will collect these participants' blood sample and draw up to 10 tsp of&#xD;
      blood. The study team will also perform a COVID-19 rapid antibody test, which uses two-three&#xD;
      drops of blood from a finger prick. These participants will also be asked to complete a short&#xD;
      (5-minute) online questionnaire.&#xD;
&#xD;
      After this visit, if these participants have not already been vaccinated, then the study team&#xD;
      will give them the option to participate in one more visit at their house or at UNC within&#xD;
      1-3 months after they receive the COVID vaccine to collect a blood sample (up to 10 tsp). The&#xD;
      study team will also repeat the rapid antibody test with another finger prick.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 29, 2020</start_date>
  <completion_date type="Actual">September 1, 2021</completion_date>
  <primary_completion_date type="Actual">September 1, 2021</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>Number of Households with New SARS-CoV-2 Infection by Day 28</measure>
    <time_frame>28 days</time_frame>
    <description>Secondary household infection rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risk Factors Associated with Secondary Household Transmission</measure>
    <time_frame>28 days</time_frame>
    <description>Secondary household infection rate risk factors</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Self-Swab Tests vs. NP Swabs at Day 1 with Detectable Viral Load</measure>
    <time_frame>1 day</time_frame>
    <description>Sensitivity of self-collected nasal swabs</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">315</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>COV Participants</arm_group_label>
    <description>COVID-positive index cases (COV): Participants who are greater than or equal to 18 years of age who test positive for COVID-19 by positive NP swab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COV-HC Participants</arm_group_label>
    <description>Household contact of COVID-positive index case (COV-HC): Household contacts greater than 1 year of age currently living in the same home as the COVID-positive index case</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>COVID-19 IgM-IgG Rapid Test</intervention_name>
    <description>Used to detect the IgG and IgM antibodies of the novel coronavirus in human whole blood (capillary or venous), serum, or plasma.</description>
    <arm_group_label>COV Participants</arm_group_label>
    <arm_group_label>COV-HC Participants</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      nasopharyngeal swabs, nasal swabs, nasal strips, blood samples, saliva samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Men and women ≥ 18 years of age who are SARS-CoV-2 PCR positive undergoing home quarantine&#xD;
        &amp; immediate household contacts, both male and female, ≥ 1 year of age will all be asked to&#xD;
        participate in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        COVID-positive index cases (COV):&#xD;
&#xD;
          -  Any patient greater than or equal to18 years of age with a positive qualitative&#xD;
             nasopharyngeal or nasal swab for SARS-CoV-2 obtained at UNC Hospitals or an outpatient&#xD;
             clinic&#xD;
&#xD;
          -  COVID-19 diagnosis by positive NP swab&#xD;
&#xD;
          -  Willingness to self-isolate at home for a 14-day period&#xD;
&#xD;
          -  Living with at least one household contact who is also willing to consent to study&#xD;
             follow-up&#xD;
&#xD;
          -  Living within reasonable driving distance (&lt;1 hour) suitable for home visits by study&#xD;
             team&#xD;
&#xD;
        Household contact of COVID-positive index case (COV-HC):&#xD;
&#xD;
        • Household contacts greater than 1 year of age currently living in the same home as the&#xD;
        COVID-positive index case without plans to leave to live elsewhere through the end of the&#xD;
        28-day study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        COVID-positive index cases (COV): None&#xD;
&#xD;
        Household contact of COVID-positive index case (COV-HC):&#xD;
&#xD;
        • Previously participated in this study (as index case or household contact)&#xD;
&#xD;
        For the extension part of CO-HOST, study participants greater than 65 years of age who&#xD;
        tested positive for acute SAR-CoV-2 infection by PCR or seroconversion (antibody status&#xD;
        became positive) during their participation in the first month of the study, will be&#xD;
        eligible. They will be excluded if they previously received immunologic therapy (i.e.,&#xD;
        exogenous anti-SARS-CoV-2 monoclonal antibodies) for COVID-19 infection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jessica Lin, MD, MSCR</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC-Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina Health Care</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Household</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Coronavirus</keyword>
  <keyword>Infection</keyword>
  <keyword>Transmission</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Nasopharyngeal</keyword>
  <keyword>Nasal Swabs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator/researcher who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>12-24 months after publication</ipd_time_frame>
    <ipd_access_criteria>Investigators/researchers who propose to use study data will need to have IRB, IEC, or REB approval and an executed data use/sharing agreement with UNC.</ipd_access_criteria>
  </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/NCT04445233
org study id: 20-0982
secondary id: 550KR242023
nct id: NCT04445233
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This study will test and follow persons quarantined at home after testing positive for
      SARS-CoV-2 (COV) aged 18 years and older and their household members aged 1 year and older.

      The purpose of this research study is to understand how often COVID-19 (Coronavirus Disease
      2019) spreads in the household when someone who tests positive for the virus self-isolates at
      home.

      The purpose of the extension part of the study is to help us understand long-term immunity to
      COVID-19. We are interested in how our immune system might still protect us from COVID-19
      even after antibody levels decrease or are no longer detected. We are also interested in how
      immunity to COVID-19 is different in kids vs. adults.
This study will enroll approximately 200 men and women ≥ 18 years of age who are SARS-CoV-2
      PCR positive undergoing home quarantine & approximately 200-1500 immediate household
      contacts, both male and female, ≥ 1 year of age.

      This study will test and follow persons quarantined at home after testing positive for
      SARS-CoV-2 (COV) and their household members.

      The CO-HOST mobile nurse initiates a home visit to the home of the COVID-19 index case after
      they and their household members (COV-HC) verbally express interest in the study and provide
      consent or assent as appropriate. At the first visit, nasopharyngeal (NP) swabs and blood are
      collected from COV and all members of the household (COV-HC) to determine infection status.
      Additional samples (nasal swabs, saliva, nasal strips), both nurse-collected and
      self-collected, may also be collected from COV and COV-HC. The nurse will provide specific
      instructions and training on how to perform self-collected swabs.

      Every week, thereafter, COV-HC are tested during the 28 days of the study. If home visits are
      not possible, then participants will perform self-collected swabs for testing. If COV-HC
      develops symptoms, they will be referred per standard of care (SOC).

      If COV or COV-HC are hospitalized, they will remain in the study for outcome assessment, but
      without further sample collections.

      As part of the extension to the study, the study team will come back to previous enrolled
      participants' houses for a single visit at about 6 months from when they enrolled in this
      study. If these participants prefer, they could come to UNC for this visit instead. At this
      visit, the study team will collect these participants' blood sample and draw up to 10 tsp of
      blood. The study team will also perform a COVID-19 rapid antibody test, which uses two-three
      drops of blood from a finger prick. These participants will also be asked to complete a short
      (5-minute) online questionnaire.

      After this visit, if these participants have not already been vaccinated, then the study team
      will give them the option to participate in one more visit at their house or at UNC within
      1-3 months after they receive the COVID vaccine to collect a blood sample (up to 10 tsp). The
      study team will also repeat the rapid antibody test with another finger prick.
observational model: Cohort
time perspective: Prospective
measure: Number of Households with New SARS-CoV-2 Infection by Day 28
time frame: 28 days
description: Secondary household infection rate
measure: Risk Factors Associated with Secondary Household Transmission
time frame: 28 days
description: Secondary household infection rate risk factors
measure: Number of Self-Swab Tests vs. NP Swabs at Day 1 with Detectable Viral Load
time frame: 1 day
description: Sensitivity of self-collected nasal swabs
arm group label: COV Participants
description: COVID-positive index cases (COV): Participants who are greater than or equal to 18 years of age who test positive for COVID-19 by positive NP swab
arm group label: COV-HC Participants
description: Household contact of COVID-positive index case (COV-HC): Household contacts greater than 1 year of age currently living in the same home as the COVID-positive index case
intervention type: Device
intervention name: COVID-19 IgM-IgG Rapid Test
description: Used to detect the IgG and IgM antibodies of the novel coronavirus in human whole blood (capillary or venous), serum, or plasma.
arm group label: COV Participants
arm group label: COV-HC Participants
nasopharyngeal swabs, nasal swabs, nasal strips, blood samples, saliva samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jessica Lin, MD, MSCR
role: Principal Investigator
affiliation: UNC-Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Yes
ipd description: De-identified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator/researcher who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
ipd info type: Study Protocol
ipd time frame: 12-24 months after publication
ipd access criteria: Investigators/researchers who propose to use study data will need to have IRB, IEC, or REB approval and an executed data use/sharing agreement with UNC.