<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/NCT04474288</url>
  </required_header>
  <id_info>
    <org_study_id>1613182</org_study_id>
    <nct_id>NCT04474288</nct_id>
  </id_info>
  <brief_title>The COVID-19 PUI Reality Check (CPRC) Study</brief_title>
  <acronym>CPRC</acronym>
  <official_title>SARS-CoV-2 Specific Immune Responses in Hospitalized Persons Under Investigation (PUIs) With Negative Nasopharyngeal PCR Swabs - The COVID-19 PUI Reality Check (CPRC) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bassett Healthcare</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bioreference, Inc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bassett Healthcare</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 study compares SARS-CoV-2 immune responses in high pretest probability swab negative&#xD;
      hospitalized PUI patients vs. low pretest probability swab negative hospitalized APS&#xD;
      (Asymptomatic Persons being Screened) patients to try to understand the appropriateness and&#xD;
      safety of clinical decisions made in these patient populations based on swab results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is essentially a two phase blood drawing and immune assays study. Phase 1 will be a&#xD;
      single convalescent timing immune retrospective study; phase 2 will include paired samples to&#xD;
      increase immune response accuracy in a prospective study. In phase 1, hospitalized PUI and&#xD;
      APS patients with negative nasopharyngeal PCR swabs selected by Epic query of Bassett&#xD;
      records, will be contacted by telephone (or in person if hospitalized), offered enrollment in&#xD;
      the study, and provided informed consent if they're interested. For consented/enrolled&#xD;
      patients, routine baseline demographic and clinical data will be obtained by interview (in&#xD;
      person or telephone) and/or EMR (Epic) review. These data will be needed to describe baseline&#xD;
      characteristics and to assess for predictors of serologic conversion and other immune&#xD;
      responses in the two study populations. Up to two to three visits will be required for brief&#xD;
      interviews, record review, and blood draws. Phase 1 patients will have visits/blood draws on&#xD;
      days 14 and 28 after hospitalization or at 28 days after hospitalization only (-3 days, +60&#xD;
      days) if patients are beyond day 14 at the time of study initiation; phase 2 patients will&#xD;
      have visits/blood draws aiming for days 0, 14 (+/- 3 days), and 28 (+/- 3 days) after&#xD;
      hospital admission.&#xD;
&#xD;
      Blood will be drawn for SARS-CoV-2 specific immune assays (below). For phase 1 patients,&#xD;
      baseline immune assays will not be available as blood is not available for them; thus, for&#xD;
      many phase 1 patients, only one of the day 14 and 28 immune assays will be practical. In&#xD;
      Phase 2, these procedures will be the same except baseline blood draws will be possible at&#xD;
      hospitalization as well. Thus, blood drawing will be at target days 0, 14, and 28 for phase 2&#xD;
      patients. Short interviews at days 14 and 28 will be conducted to assess for new COVID-19&#xD;
      compatible illnesses that may confound immune response results.&#xD;
&#xD;
      Up to 27.5 ml of blood will be required at each timepoint (PAXgene tube 2.5 ml, heparinized&#xD;
      tube 10 ml, EDTA tube 10 ml, SST tube 5 ml). Total blood drawing will be up to 55 ml in phase&#xD;
      1 patients and up to 82.5 ml in phase 2 patients. Serologic and additional immune assays will&#xD;
      be conducted on blood drawn at these time points to assess for SARS-CoV-2 specific immune&#xD;
      responses (see below).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 16, 2020</start_date>
  <completion_date type="Actual">February 28, 2022</completion_date>
  <primary_completion_date type="Actual">July 1, 2021</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>SARS-CoV-2 IgG</measure>
    <time_frame>120 days</time_frame>
    <description>Qualitative seroconversion response rates (RR) in NP SARS-CoV-2 PCR swab negative PUI vs. swab negative APS patients will be compared as the primary outcome measurement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>host immune response</measure>
    <time_frame>120 Days</time_frame>
    <description>mRNA gene expression by RNAseq from whole blood collected into PAXGene RNA tubes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pathogen protein expression</measure>
    <time_frame>120 days</time_frame>
    <description>identification of a signature of differentially expressed host genes or antigen/epitope specific antibody or cellular responses.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">37</enrollment>
  <condition>Covid19 Immunology</condition>
  <arm_group>
    <arm_group_label>Person Under Investigation (PUI)</arm_group_label>
    <description>PUI's are subjects who were admitted to the hospital with symptoms suspicious for COVID-19.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Asymptomatic Person under Screening (APS)</arm_group_label>
    <description>APS's are those patients who do NOT meet the criteria to be a suspect COVID- 19 patient but are being tested because they are being admitted, are required for testing by state mandate, or are having a procedure, etc.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>SARS-CoV-2 antibody testing</intervention_name>
    <description>venipuncture for SARS-CoV-2 IgG</description>
    <arm_group_label>Asymptomatic Person under Screening (APS)</arm_group_label>
    <arm_group_label>Person Under Investigation (PUI)</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Biospecimens will be analyzed to assess antibody levels, RNA analysis, and analysis of other&#xD;
      immunological markers. Subjects have the option to allow their specimens to be retained for&#xD;
      future designated research.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized patients who have had pharyngeal testing negative for the presence of COVID-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Hospitalized patient (PUI or APS) and tested for SARS-CoV-2 by NP PCR swab&#xD;
&#xD;
          -  At least one negative SARS-CoV-2 NP PCR swab within 2 wks of hospitalization&#xD;
&#xD;
          -  Adult &gt;/= 18 yrs old&#xD;
&#xD;
          -  Patient or LAR provides informed consent&#xD;
&#xD;
          -  Patient or LAR agree to follow-up procedures in informed consent form&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Prior reaction to blood drawing considered significant safety issue by study&#xD;
             investigator&#xD;
&#xD;
          -  Other factor considered significant safety issue by study investigator&#xD;
&#xD;
          -  At least one positive SARS-CoV-2 NP PCR swab within 2 wks of hospitalization&#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>Daniel Freilich, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bassett Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bassett Medical Center</name>
      <address>
        <city>Cooperstown</city>
        <state>New York</state>
        <zip>13326</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>March 9, 2022</last_update_submitted>
  <last_update_submitted_qc>March 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bassett Healthcare</investigator_affiliation>
    <investigator_full_name>Daniel Freilich, MD</investigator_full_name>
    <investigator_title>attending physician - hospitalist/infectious disease</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04474288
org study id: 1613182
nct id: NCT04474288
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study compares SARS-CoV-2 immune responses in high pretest probability swab negative
      hospitalized PUI patients vs. low pretest probability swab negative hospitalized APS
      (Asymptomatic Persons being Screened) patients to try to understand the appropriateness and
      safety of clinical decisions made in these patient populations based on swab results.
This is essentially a two phase blood drawing and immune assays study. Phase 1 will be a
      single convalescent timing immune retrospective study; phase 2 will include paired samples to
      increase immune response accuracy in a prospective study. In phase 1, hospitalized PUI and
      APS patients with negative nasopharyngeal PCR swabs selected by Epic query of Bassett
      records, will be contacted by telephone (or in person if hospitalized), offered enrollment in
      the study, and provided informed consent if they're interested. For consented/enrolled
      patients, routine baseline demographic and clinical data will be obtained by interview (in
      person or telephone) and/or EMR (Epic) review. These data will be needed to describe baseline
      characteristics and to assess for predictors of serologic conversion and other immune
      responses in the two study populations. Up to two to three visits will be required for brief
      interviews, record review, and blood draws. Phase 1 patients will have visits/blood draws on
      days 14 and 28 after hospitalization or at 28 days after hospitalization only (-3 days, +60
      days) if patients are beyond day 14 at the time of study initiation; phase 2 patients will
      have visits/blood draws aiming for days 0, 14 (+/- 3 days), and 28 (+/- 3 days) after
      hospital admission.

      Blood will be drawn for SARS-CoV-2 specific immune assays (below). For phase 1 patients,
      baseline immune assays will not be available as blood is not available for them; thus, for
      many phase 1 patients, only one of the day 14 and 28 immune assays will be practical. In
      Phase 2, these procedures will be the same except baseline blood draws will be possible at
      hospitalization as well. Thus, blood drawing will be at target days 0, 14, and 28 for phase 2
      patients. Short interviews at days 14 and 28 will be conducted to assess for new COVID-19
      compatible illnesses that may confound immune response results.

      Up to 27.5 ml of blood will be required at each timepoint (PAXgene tube 2.5 ml, heparinized
      tube 10 ml, EDTA tube 10 ml, SST tube 5 ml). Total blood drawing will be up to 55 ml in phase
      1 patients and up to 82.5 ml in phase 2 patients. Serologic and additional immune assays will
      be conducted on blood drawn at these time points to assess for SARS-CoV-2 specific immune
      responses (see below).
observational model: Case-Control
time perspective: Other
measure: SARS-CoV-2 IgG
time frame: 120 days
description: Qualitative seroconversion response rates (RR) in NP SARS-CoV-2 PCR swab negative PUI vs. swab negative APS patients will be compared as the primary outcome measurement.
measure: host immune response
time frame: 120 Days
description: mRNA gene expression by RNAseq from whole blood collected into PAXGene RNA tubes
measure: pathogen protein expression
time frame: 120 days
description: identification of a signature of differentially expressed host genes or antigen/epitope specific antibody or cellular responses.
arm group label: Person Under Investigation (PUI)
description: PUI's are subjects who were admitted to the hospital with symptoms suspicious for COVID-19.
arm group label: Asymptomatic Person under Screening (APS)
description: APS's are those patients who do NOT meet the criteria to be a suspect COVID- 19 patient but are being tested because they are being admitted, are required for testing by state mandate, or are having a procedure, etc.
intervention type: Diagnostic Test
intervention name: SARS-CoV-2 antibody testing
description: venipuncture for SARS-CoV-2 IgG
arm group label: Asymptomatic Person under Screening (APS)
arm group label: Person Under Investigation (PUI)
Biospecimens will be analyzed to assess antibody levels, RNA analysis, and analysis of other
      immunological markers. Subjects have the option to allow their specimens to be retained for
      future designated research.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Freilich, MD
role: Principal Investigator
affiliation: Bassett Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Bassett Healthcare
investigator full name: Daniel Freilich, MD
investigator title: attending physician - hospitalist/infectious disease
mesh term: COVID-19
mesh term: Antibodies