<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/NCT04407546</url>
  </required_header>
  <id_info>
    <org_study_id>20-000517</org_study_id>
    <secondary_id>NCI-2020-03669</secondary_id>
    <nct_id>NCT04407546</nct_id>
  </id_info>
  <brief_title>Role of Children in Transmission of COVID-19 to Immunocompromised Patients</brief_title>
  <official_title>Role of Children in the Transmission of SARS-CoV-2 in Households of Immunocompromised Persons</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jonsson Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jonsson Comprehensive Cancer Center</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 study of immunosuppressed individuals living in households with and without&#xD;
      children to assess the role of household contact with children in the transmission of&#xD;
      SARSCoV-2 to immunocompromised individuals. Through careful collection of epidemiological&#xD;
      data in combination with biological specimens, risk factors for SARS-CoV-2 in&#xD;
      immunocompromised individuals will be identified. During the initial visits, informed consent&#xD;
      will be obtained and consented participants will complete an initial questionnaire and&#xD;
      provide biological specimens including nasal swabs, saliva and blood. Thereafter,&#xD;
      participants will complete at-home saliva collections and questionnaires on a weekly basis&#xD;
      for 6 months. If our research-use only SARS-CoV-2 test is positive, participants will be&#xD;
      referred immediately for medical attention and will be followed every 3 days with nasal swabs&#xD;
      and saliva samples and weekly blood specimens and optional rectal swabs or fresh stool&#xD;
      collection. Additionally, participants will be contacted by telephone at 1 year for&#xD;
      follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, longitudinal cohort study of immunosuppressed patients living in&#xD;
      households with and without children to assess the role of household contact with children in&#xD;
      the transmission of SARS-CoV-2 to immunocompromised patients. This study will be enrolling&#xD;
      both pediatric and adult patients who are immunosuppressed, as well as their household&#xD;
      members who agree to participate. Through careful collection of epidemiological data in&#xD;
      combination with biological specimens, risk factors for SARS- CoV-2 in immunocompromised&#xD;
      patients will be identified. During the initial study visit, informed consent will be&#xD;
      obtained, the study questionnaire will be completed and the participant will provide&#xD;
      biological specimens including nasal mid-turbinate swabs, saliva and blood. Thereafter,&#xD;
      participants will complete at-home saliva collections and questionnaires on a weekly basis&#xD;
      for 6 months. If our research-use only SARS-CoV-2 test is positive, participants will be&#xD;
      referred immediately to University of California at Los Angeles(UCLA) Health for medical&#xD;
      attention and will be followed every 3 days with nasal swabs and saliva samples, and weekly&#xD;
      blood specimens and optional rectal swabs or fresh stool collection. Biological specimen and&#xD;
      questionnaire follow-up will occur for 6 months for uninfected participants or until the of&#xD;
      end of viral shedding and immunologic profiling for patients infected with SARS-CoV-2,&#xD;
      whichever is longer. All participants will be followed at 6 months with the same baseline&#xD;
      measurements and then participants will be contacted by telephone at 1 year.&#xD;
&#xD;
      The clinical data and biological specimens collected in this initial study will provide will&#xD;
      inform and allow future studies of clinical outcomes, viral characteristics, and immune&#xD;
      responses to SARS-CoV-2 infection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">May 27, 2020</start_date>
  <completion_date type="Actual">March 13, 2023</completion_date>
  <primary_completion_date type="Actual">March 13, 2023</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>To define the role of household contact with children or siblings in the transmission of SARS-CoV-2 to immunocompromised patients.</measure>
    <time_frame>up to one year</time_frame>
    <description>Measure the incidence of transmission of SARS-CoV-2 to immunocompromised patients in households with children compared to households without children</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To characterize secondary cases of SARS-CoV-2 in immunocompromised participants</measure>
    <time_frame>up to one year</time_frame>
    <description>Measure the rate of serology conversion of SARS-CoV-2 to immunocompromised patients in households with children compared to households without children</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To describe the exposure factors such as pets and travel and how those factors are related to immunocompromised patients to estimate risk profiles by household characteristics</measure>
    <time_frame>up to one year</time_frame>
    <description>Measure the rates of exposures to the following risk factors: persons with positive SARS-CoV-2 PCR test, pets, previous travel to the incidence of transmission of SARS-CoV-2 to immunocompromised patients in households with children compared to households without children.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">109</enrollment>
  <condition>Immunosuppression</condition>
  <arm_group>
    <arm_group_label>Families with Children</arm_group_label>
    <description>Families containing an immunocompromised individual that have children in the family setting.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Famlies without children</arm_group_label>
    <description>Families containing an immunocompromised individual that do not have children in the family setting.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Subjects to provide biological specimens including nasal swabs, saliva and blood. Thereafter,&#xD;
      participants will complete at-home nasal swab collections on a weekly basis for 6 months. If&#xD;
      our research-use only SARS-CoV-2 test is positive, participants will be referred immediately&#xD;
      to UCLA for medical attention and will be followed every 3 days with nasal swabs and saliva&#xD;
      samples and weekly blood specimens and optional rectal swabs or fresh stool collection.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Potentially eligible patients will be identified through examination of the electronic&#xD;
        health record to identify patients receiving chemotherapy who are potentially eligible and&#xD;
        could be approached for participation. Invitation to the study will occur through the&#xD;
        MyChart portal or paper mailing letter, and those who are interested in participation will&#xD;
        contact the research coordinator by phone or e-mail to undergo telephone screening for&#xD;
        study eligibility. In addition, the research team member will explain the study objectives&#xD;
        and procedures, and assess interest in participation. Pediatric recruitment of solid organ&#xD;
        and hematopoietic stem cell transplantation patients will be done in collaboration with&#xD;
        those respective primary pediatric subspecialist. The pediatric subspecialist teams will&#xD;
        identify the patients who meet the inclusion criteria and will send the recruitment letter&#xD;
        directly to the parents or patients if &gt;18 years old via MyChart or paper mailed letter.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Immunocompromised patient followed at UCLA Health&#xD;
&#xD;
          -  Immunocompromised patient &gt;1 day old to &lt;60 years of age&#xD;
&#xD;
          -  Patient with a diagnosis of breast, lung, or colorectal cancers, lymphoma,&#xD;
             acute/chronic leukemia, multiple myeloma, or other solid tumors and are receiving&#xD;
             chemotherapy&#xD;
&#xD;
          -  Patients who have received a hematopoietic stem cell transplantation within the last&#xD;
             year&#xD;
&#xD;
          -  Patients who have received a solid organ transplantation within the last year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Immunocompromised patients with positive SARS-CoV-2 test prior to study enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Grace Aldrovandi, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Califiornia at Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California at Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 27, 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>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04407546
org study id: 20-000517
secondary id: NCI-2020-03669
nct id: NCT04407546
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a study of immunosuppressed individuals living in households with and without
      children to assess the role of household contact with children in the transmission of
      SARSCoV-2 to immunocompromised individuals. Through careful collection of epidemiological
      data in combination with biological specimens, risk factors for SARS-CoV-2 in
      immunocompromised individuals will be identified. During the initial visits, informed consent
      will be obtained and consented participants will complete an initial questionnaire and
      provide biological specimens including nasal swabs, saliva and blood. Thereafter,
      participants will complete at-home saliva collections and questionnaires on a weekly basis
      for 6 months. If our research-use only SARS-CoV-2 test is positive, participants will be
      referred immediately for medical attention and will be followed every 3 days with nasal swabs
      and saliva samples and weekly blood specimens and optional rectal swabs or fresh stool
      collection. Additionally, participants will be contacted by telephone at 1 year for
      follow-up.
This is a prospective, longitudinal cohort study of immunosuppressed patients living in
      households with and without children to assess the role of household contact with children in
      the transmission of SARS-CoV-2 to immunocompromised patients. This study will be enrolling
      both pediatric and adult patients who are immunosuppressed, as well as their household
      members who agree to participate. Through careful collection of epidemiological data in
      combination with biological specimens, risk factors for SARS- CoV-2 in immunocompromised
      patients will be identified. During the initial study visit, informed consent will be
      obtained, the study questionnaire will be completed and the participant will provide
      biological specimens including nasal mid-turbinate swabs, saliva and blood. Thereafter,
      participants will complete at-home saliva collections and questionnaires on a weekly basis
      for 6 months. If our research-use only SARS-CoV-2 test is positive, participants will be
      referred immediately to University of California at Los Angeles(UCLA) Health for medical
      attention and will be followed every 3 days with nasal swabs and saliva samples, and weekly
      blood specimens and optional rectal swabs or fresh stool collection. Biological specimen and
      questionnaire follow-up will occur for 6 months for uninfected participants or until the of
      end of viral shedding and immunologic profiling for patients infected with SARS-CoV-2,
      whichever is longer. All participants will be followed at 6 months with the same baseline
      measurements and then participants will be contacted by telephone at 1 year.

      The clinical data and biological specimens collected in this initial study will provide will
      inform and allow future studies of clinical outcomes, viral characteristics, and immune
      responses to SARS-CoV-2 infection.
observational model: Cohort
time perspective: Prospective
measure: To define the role of household contact with children or siblings in the transmission of SARS-CoV-2 to immunocompromised patients.
time frame: up to one year
description: Measure the incidence of transmission of SARS-CoV-2 to immunocompromised patients in households with children compared to households without children
measure: To characterize secondary cases of SARS-CoV-2 in immunocompromised participants
time frame: up to one year
description: Measure the rate of serology conversion of SARS-CoV-2 to immunocompromised patients in households with children compared to households without children
measure: To describe the exposure factors such as pets and travel and how those factors are related to immunocompromised patients to estimate risk profiles by household characteristics
time frame: up to one year
description: Measure the rates of exposures to the following risk factors: persons with positive SARS-CoV-2 PCR test, pets, previous travel to the incidence of transmission of SARS-CoV-2 to immunocompromised patients in households with children compared to households without children.
arm group label: Families with Children
description: Families containing an immunocompromised individual that have children in the family setting.
arm group label: Famlies without children
description: Families containing an immunocompromised individual that do not have children in the family setting.
Subjects to provide biological specimens including nasal swabs, saliva and blood. Thereafter,
      participants will complete at-home nasal swab collections on a weekly basis for 6 months. If
      our research-use only SARS-CoV-2 test is positive, participants will be referred immediately
      to UCLA for medical attention and will be followed every 3 days with nasal swabs and saliva
      samples and weekly blood specimens and optional rectal swabs or fresh stool collection.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Grace Aldrovandi, M.D.
role: Principal Investigator
affiliation: University of Califiornia at Los Angeles
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided