<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/NCT04472793</url>
  </required_header>
  <id_info>
    <org_study_id>RETURN</org_study_id>
    <nct_id>NCT04472793</nct_id>
  </id_info>
  <brief_title>Repeated Employee Testing for Understanding Our Recovery to Normal</brief_title>
  <acronym>RETURN</acronym>
  <official_title>Repeated Employee Testing for Understanding Our Recovery to Normal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</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 research study is 1) to conduct a prospective longitudinal surveillance&#xD;
      research trial, enrolling up to 200 CCHMC employees as they come back to work, and then&#xD;
      following their clinical and laboratory parameters for up to 12 months; and 2) to support the&#xD;
      ongoing development of diagnostic techniques for COVID-19. The overall goal is to investigate&#xD;
      patterns of SARS-COV-2 infection, including immunological recovery and genetic risk factors,&#xD;
      among CCHMC employees to better understand how to safely reintroduce the CCHMC work force&#xD;
      back into their normal routines.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As the global and pandemic spread of the novel coronavirus (SARS-CoV-2, COVID-19) continues,&#xD;
      many knowledge gaps remain with regard to the epidemiology and transmission of infection, as&#xD;
      well as the normal immunological responses after viral exposure. Cincinnati only recently&#xD;
      (March 14, 2020) had its first confirmed case of COVID-19, and through shelter-in-place and&#xD;
      social distancing efforts, has avoided the community spread experienced by some other large&#xD;
      metropolitan areas. As investigators contemplate the gradual reintroduction of the Cincinnati&#xD;
      Children's Hospital Medical Center (CCHMC) workforce back into the hospital, it is imperative&#xD;
      that investigators determine the current prevalence of infection among CCHMC employees,&#xD;
      measure the cumulative incidence of infection over the next 12 months, investigate the normal&#xD;
      antibody patterns after infection, and help elucidate what constitutes a protective&#xD;
      immunological response. Investigators have a unique but time-limited opportunity to optimally&#xD;
      track the epidemiology and natural history of SARS-CoV-2 infection at CCHMC, including risk&#xD;
      factors for transmission and immunological recovery. RETURN will investigate epidemiological&#xD;
      and immunological features of SARS-CoV-2 virus infection in a limited cohort of CCHMC&#xD;
      employees, as they return from the current shelter-at-home directive toward a normal work&#xD;
      environment. By collecting and analyzing weekly serial samples for SARS-CoV-2 (nasal swab for&#xD;
      virus by PCR) and monthly serological exposure (serum antibodies by ELISA), investigators&#xD;
      will determine the prevalence and cumulative incidence of exposure to SARS-CoV-2; document&#xD;
      the antibody responses over time; identify cases of apparent viral recrudescence or&#xD;
      re-infection; and create models of transmission risk among CCHMC employees.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 11, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The 6-month cumulative incidence of acquired COVID infection in the study cohort.</measure>
    <time_frame>Weekly for 6 months</time_frame>
    <description>Acquired COVID is defined as testing negative for COVID at baseline and having 1 or more weekly nasal swab samples testing positive for the virus by PCR</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Full-Time CCHMC Employees</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>SARS-CoV-2</intervention_name>
    <description>Testing weekly samples from nasal swabs to promptly diagnose acute COVID-19 infection.&#xD;
Testing monthly serum samples to document post-viral infection.</description>
    <arm_group_label>Full-Time CCHMC Employees</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum and DNA Samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult men and women who are employed full time at Cincinnati Children's Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current full-time employees at Cincinnati Children's Hospital&#xD;
&#xD;
          -  Age: &gt;18.0 years of age, at the time of enrollment&#xD;
&#xD;
          -  Cell phone that can be used for text messaging or web-based viewing of surveys&#xD;
&#xD;
          -  Willing and able to provide informed consent&#xD;
&#xD;
          -  Ability to comply with all study related evaluations and follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous proven SARS-CoV-2 infection (positive PCR-based molecular test)&#xD;
&#xD;
          -  Any condition or illness that makes study participation ill-advised&#xD;
&#xD;
          -  Currently or planning to enroll in a COVID-19 vaccine or prophylaxis study&#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>Russell Ware, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mary Allen Staat, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04472793
org study id: RETURN
nct id: NCT04472793
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is 1) to conduct a prospective longitudinal surveillance
      research trial, enrolling up to 200 CCHMC employees as they come back to work, and then
      following their clinical and laboratory parameters for up to 12 months; and 2) to support the
      ongoing development of diagnostic techniques for COVID-19. The overall goal is to investigate
      patterns of SARS-COV-2 infection, including immunological recovery and genetic risk factors,
      among CCHMC employees to better understand how to safely reintroduce the CCHMC work force
      back into their normal routines.
As the global and pandemic spread of the novel coronavirus (SARS-CoV-2, COVID-19) continues,
      many knowledge gaps remain with regard to the epidemiology and transmission of infection, as
      well as the normal immunological responses after viral exposure. Cincinnati only recently
      (March 14, 2020) had its first confirmed case of COVID-19, and through shelter-in-place and
      social distancing efforts, has avoided the community spread experienced by some other large
      metropolitan areas. As investigators contemplate the gradual reintroduction of the Cincinnati
      Children's Hospital Medical Center (CCHMC) workforce back into the hospital, it is imperative
      that investigators determine the current prevalence of infection among CCHMC employees,
      measure the cumulative incidence of infection over the next 12 months, investigate the normal
      antibody patterns after infection, and help elucidate what constitutes a protective
      immunological response. Investigators have a unique but time-limited opportunity to optimally
      track the epidemiology and natural history of SARS-CoV-2 infection at CCHMC, including risk
      factors for transmission and immunological recovery. RETURN will investigate epidemiological
      and immunological features of SARS-CoV-2 virus infection in a limited cohort of CCHMC
      employees, as they return from the current shelter-at-home directive toward a normal work
      environment. By collecting and analyzing weekly serial samples for SARS-CoV-2 (nasal swab for
      virus by PCR) and monthly serological exposure (serum antibodies by ELISA), investigators
      will determine the prevalence and cumulative incidence of exposure to SARS-CoV-2; document
      the antibody responses over time; identify cases of apparent viral recrudescence or
      re-infection; and create models of transmission risk among CCHMC employees.
observational model: Case-Control
time perspective: Prospective
measure: The 6-month cumulative incidence of acquired COVID infection in the study cohort.
time frame: Weekly for 6 months
description: Acquired COVID is defined as testing negative for COVID at baseline and having 1 or more weekly nasal swab samples testing positive for the virus by PCR
arm group label: Full-Time CCHMC Employees
intervention type: Diagnostic Test
intervention name: SARS-CoV-2
description: Testing weekly samples from nasal swabs to promptly diagnose acute COVID-19 infection.
Testing monthly serum samples to document post-viral infection.
arm group label: Full-Time CCHMC Employees
Serum and DNA Samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Russell Ware, MD, PhD
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
last name: Mary Allen Staat, MD, MPH
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No