<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/NCT04497779</url>
  </required_header>
  <id_info>
    <org_study_id>20204</org_study_id>
    <secondary_id>NCI-2020-04000</secondary_id>
    <secondary_id>20204</secondary_id>
    <secondary_id>P30CA033572</secondary_id>
    <secondary_id>TGen</secondary_id>
    <nct_id>NCT04497779</nct_id>
  </id_info>
  <brief_title>Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma</brief_title>
  <official_title>Evaluation of Coronavirus Disease 19 (COVID-19) Convalescent Plasma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>City of Hope Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>California Institute for Regenerative Medicine (CIRM)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>City of Hope Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Plasma from patients who have recovered from coronavirus disease 2019 (COVID-19) is referred&#xD;
      to as COVID-19 convalescent plasma (CCP), and may contain antibodies against SARS-CoV-2, the&#xD;
      virus responsible for COVID-19. CCP infusion is being evaluated as a therapeutic or&#xD;
      prophylactic approach in COVID-19 patients. The goal of this study is to help develop a bank&#xD;
      of convalescent plasma in California, especially in medically underserved communities&#xD;
      particularly affected by the disease. In parallel, CCP administered to COVID-19 patients will&#xD;
      be collected and analyzed to determine whether the antibody profile correlates with clinical&#xD;
      outcome. The purpose of this non-therapeutic study is to learn more about the CCP antibody&#xD;
      profile and the effect it may have in treating COVID-19 infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Establish a testing service for screening prospective donors of coronavirus disease 2019&#xD;
      (COVID-19) convalescent plasma (CCP).&#xD;
&#xD;
      II. Characterize the titer and neutralizing properties of severe acute respiratory syndrome&#xD;
      coronavirus 2 (SARS-CoV-2) antibodies in CCP.&#xD;
&#xD;
      III. Correlate the SARS-CoV-2 antibody characteristics in CCP with the outcome in severely&#xD;
      ill COVID-19 patients treated with CCP.&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. Facilitate the recruitment of CCP donors in medically underserved areas.&#xD;
&#xD;
      II. Develop high-throughput methods for detection/characterization of SARS-CoV-2 neutralizing&#xD;
      and non-neutralizing antibodies.&#xD;
&#xD;
      III. Develop a bank of convalescent plasma that would be available for future studies&#xD;
      relating to the content of CCP.&#xD;
&#xD;
      IV. Study the impact of antibody levels, donor characteristics and patient characteristics on&#xD;
      outcome in COVID-19 patients treated with CCP.&#xD;
&#xD;
      V. Procure blood samples from COVID-19 convalescent volunteers for future COVID-19-related&#xD;
      studies.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      PROSPECTIVE CCP DONORS: Participants undergo collection of blood and/or nasopharyngeal swabs&#xD;
      at the time of screening. Participants' medical records are reviewed.&#xD;
&#xD;
      CONVALESCENT BLOOD DONORS WHO CHOOSE NOT TO DONATE CCP: Participants undergo collection of&#xD;
      blood sample at the time of screening. Participants' medical records are reviewed.&#xD;
&#xD;
      CCP RECIPIENTS: Patients undergo collection collection of blood samples at baseline, between&#xD;
      CCP unit infusions, 24 hours after last CCP infusion, and between 14-28 after last CCP&#xD;
      infusion. Patients' medical records are reviewed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Anticipated">November 21, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 21, 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>Convalescent plasma (CCP) units infused in coronavirus disease-2019 (COVID-19) patients</measure>
    <time_frame>Up to 12 months after enrollment</time_frame>
    <description>Will be assayed for severe acute respiratory syndrome (SARS-CoV-2) immunoassay, coronavirus (CoV) PepSeq assay, and SARS-CoV-2 lenti-based neutralizing antibody titer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>At day 28 post-CCP infusion</time_frame>
    <description>Will naturally be compared to reported data from the other studies. Analysis will focus on demonstrating that the antibody content of donor plasma increases the odds of surviving past day 28. Will also develop a nomogram for the probability of success (alive at day 28), accounting for patient, donor material and donor antibody characteristics measurable covariates.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Donor antibody levels</measure>
    <time_frame>Up to 28 days post-CCP infusion</time_frame>
    <description>Will be examined to see how this relates to the duration of hospitalization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Up to 28 days post-CCP infusion</time_frame>
    <description>Will be assessed on a 7-point ordinal scale, as recommended by the WHO patient outcome R&amp;D Blueprint Group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CCP recipient outcomes</measure>
    <time_frame>Up to 28 days post-CCP infusion</time_frame>
    <description>Will be assessed on a 7-point ordinal scale. The scale is as follows:&#xD;
Death;&#xD;
Hospitalized, on invasive mechanical ventilation or ECMO;&#xD;
Hospitalized, on non-invasive ventilation or high flow oxygen devices;&#xD;
Hospitalized, requiring low flow supplemental oxygen;&#xD;
Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);&#xD;
Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per protocol RDV administration);&#xD;
Not hospitalized</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Duration of hospitalization (days)</measure>
    <time_frame>Up to 28 days post-CCP infusion</time_frame>
    <description>Patient can stay at the hospital for up to 28 days post-CCP infusion</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to clinical improvement (days)</measure>
    <time_frame>Up to 28 days post-CCP infusion</time_frame>
    <description>Will be assessed on a 7-point ordinal scale.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">95</enrollment>
  <condition>Asymptomatic COVID-19 Infection Laboratory-Confirmed</condition>
  <condition>Symptomatic COVID-19 Infection Laboratory-Confirmed</condition>
  <arm_group>
    <arm_group_label>Screening (biospecimen collection, medical record review, CCP)</arm_group_label>
    <description>PROSPECTIVE CCP DONORS: Participants undergo collection of blood and/or nasopharyngeal swabs at the time of screening. Participants' medical records are reviewed.&#xD;
CONVALESCENT BLOOD DONORS WHO CHOOSE NOT TO DONATE CCP: Participants undergo collection of blood sample at the time of screening. Participants' medical records are reviewed.&#xD;
CCP RECIPIENTS: Patients undergo collection of blood samples at baseline, 12-24 hours after each CCP infusion, and 7 days after last CCP infusion. Patients' medical records are reviewed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biospecimen Collection</intervention_name>
    <description>Undergo collection of blood and/or nasopharyngeal swabs</description>
    <arm_group_label>Screening (biospecimen collection, medical record review, CCP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diagnostic Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Screening (biospecimen collection, medical record review, CCP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electronic Health Record Review</intervention_name>
    <description>Donors and recipients have their medical records reviewed.</description>
    <arm_group_label>Screening (biospecimen collection, medical record review, CCP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Screening (biospecimen collection, medical record review, CCP)</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Nasopharyngeal swab, blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with diagnosis of laboratory-confirmed COVID-19 infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        For COVID-19 convalescent individuals:&#xD;
&#xD;
          -  Age: ≥ 18 years&#xD;
&#xD;
          -  Evidence of COVID-19 documented by a laboratory test either by: a diagnostic test&#xD;
             (e.g., a NP swab) at the time of illness OR a positive serological test for SARS-CoV-2&#xD;
             antibodies after recovery, if prior diagnostic testing was not performed at the time&#xD;
             COVID-19 was suspected.&#xD;
&#xD;
        Note: If volunteers can't provide evidence of COVID-19, but are otherwise eligible, then we&#xD;
        will test them for SARS-CoV-2 antibodies to confirm eligibility.&#xD;
&#xD;
          -  Be willing to complete a pre-screening questionnaire&#xD;
&#xD;
          -  Be willing to donate blood samples&#xD;
&#xD;
          -  Permit medical record review&#xD;
&#xD;
          -  For prospective CCP donors only: weigh more than 110 pounds and be in general good&#xD;
             health&#xD;
&#xD;
        For (COVID-19 convalescent plasma (CCP) recipients:&#xD;
&#xD;
          -  Be enrolled in a clinical trial involving the infusion of CCP for the treatment of&#xD;
             COVID-19.&#xD;
&#xD;
          -  Be willing to provide blood samples&#xD;
&#xD;
          -  Permit medical record review&#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>John Zaia</last_name>
    <role>Principal Investigator</role>
    <affiliation>City of Hope Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.covidplasmastudy.com/</url>
    <description>Website to register participants for the study</description>
  </link>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>November 22, 2022</last_update_submitted>
  <last_update_submitted_qc>November 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 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>Laboratory Infection</mesh_term>
  </condition_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/NCT04497779
org study id: 20204
secondary id: NCI-2020-04000
secondary id: 20204
secondary id: P30CA033572
secondary id: TGen
nct id: NCT04497779
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Plasma from patients who have recovered from coronavirus disease 2019 (COVID-19) is referred
      to as COVID-19 convalescent plasma (CCP), and may contain antibodies against SARS-CoV-2, the
      virus responsible for COVID-19. CCP infusion is being evaluated as a therapeutic or
      prophylactic approach in COVID-19 patients. The goal of this study is to help develop a bank
      of convalescent plasma in California, especially in medically underserved communities
      particularly affected by the disease. In parallel, CCP administered to COVID-19 patients will
      be collected and analyzed to determine whether the antibody profile correlates with clinical
      outcome. The purpose of this non-therapeutic study is to learn more about the CCP antibody
      profile and the effect it may have in treating COVID-19 infection.
PRIMARY OBJECTIVES:

      I. Establish a testing service for screening prospective donors of coronavirus disease 2019
      (COVID-19) convalescent plasma (CCP).

      II. Characterize the titer and neutralizing properties of severe acute respiratory syndrome
      coronavirus 2 (SARS-CoV-2) antibodies in CCP.

      III. Correlate the SARS-CoV-2 antibody characteristics in CCP with the outcome in severely
      ill COVID-19 patients treated with CCP.

      EXPLORATORY OBJECTIVES:

      I. Facilitate the recruitment of CCP donors in medically underserved areas.

      II. Develop high-throughput methods for detection/characterization of SARS-CoV-2 neutralizing
      and non-neutralizing antibodies.

      III. Develop a bank of convalescent plasma that would be available for future studies
      relating to the content of CCP.

      IV. Study the impact of antibody levels, donor characteristics and patient characteristics on
      outcome in COVID-19 patients treated with CCP.

      V. Procure blood samples from COVID-19 convalescent volunteers for future COVID-19-related
      studies.

      OUTLINE:

      PROSPECTIVE CCP DONORS: Participants undergo collection of blood and/or nasopharyngeal swabs
      at the time of screening. Participants' medical records are reviewed.

      CONVALESCENT BLOOD DONORS WHO CHOOSE NOT TO DONATE CCP: Participants undergo collection of
      blood sample at the time of screening. Participants' medical records are reviewed.

      CCP RECIPIENTS: Patients undergo collection collection of blood samples at baseline, between
      CCP unit infusions, 24 hours after last CCP infusion, and between 14-28 after last CCP
      infusion. Patients' medical records are reviewed.
observational model: Cohort
time perspective: Prospective
measure: Convalescent plasma (CCP) units infused in coronavirus disease-2019 (COVID-19) patients
time frame: Up to 12 months after enrollment
description: Will be assayed for severe acute respiratory syndrome (SARS-CoV-2) immunoassay, coronavirus (CoV) PepSeq assay, and SARS-CoV-2 lenti-based neutralizing antibody titer.
measure: All-cause mortality
time frame: At day 28 post-CCP infusion
description: Will naturally be compared to reported data from the other studies. Analysis will focus on demonstrating that the antibody content of donor plasma increases the odds of surviving past day 28. Will also develop a nomogram for the probability of success (alive at day 28), accounting for patient, donor material and donor antibody characteristics measurable covariates.
measure: Donor antibody levels
time frame: Up to 28 days post-CCP infusion
description: Will be examined to see how this relates to the duration of hospitalization.
measure: Incidence of adverse events
time frame: Up to 28 days post-CCP infusion
description: Will be assessed on a 7-point ordinal scale, as recommended by the WHO patient outcome R&D Blueprint Group.
measure: CCP recipient outcomes
time frame: Up to 28 days post-CCP infusion
description: Will be assessed on a 7-point ordinal scale. The scale is as follows:
Death;
Hospitalized, on invasive mechanical ventilation or ECMO;
Hospitalized, on non-invasive ventilation or high flow oxygen devices;
Hospitalized, requiring low flow supplemental oxygen;
Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);
Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per protocol RDV administration);
Not hospitalized
measure: Duration of hospitalization (days)
time frame: Up to 28 days post-CCP infusion
description: Patient can stay at the hospital for up to 28 days post-CCP infusion
measure: Time to clinical improvement (days)
time frame: Up to 28 days post-CCP infusion
description: Will be assessed on a 7-point ordinal scale.
arm group label: Screening (biospecimen collection, medical record review, CCP)
description: PROSPECTIVE CCP DONORS: Participants undergo collection of blood and/or nasopharyngeal swabs at the time of screening. Participants' medical records are reviewed.
CONVALESCENT BLOOD DONORS WHO CHOOSE NOT TO DONATE CCP: Participants undergo collection of blood sample at the time of screening. Participants' medical records are reviewed.
CCP RECIPIENTS: Patients undergo collection of blood samples at baseline, 12-24 hours after each CCP infusion, and 7 days after last CCP infusion. Patients' medical records are reviewed.
intervention type: Procedure
intervention name: Biospecimen Collection
description: Undergo collection of blood and/or nasopharyngeal swabs
arm group label: Screening (biospecimen collection, medical record review, CCP)
intervention type: Other
intervention name: Diagnostic Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Screening (biospecimen collection, medical record review, CCP)
intervention type: Other
intervention name: Electronic Health Record Review
description: Donors and recipients have their medical records reviewed.
arm group label: Screening (biospecimen collection, medical record review, CCP)
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Screening (biospecimen collection, medical record review, CCP)
Nasopharyngeal swab, blood 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: John Zaia
role: Principal Investigator
affiliation: City of Hope Medical Center
facility: 
country: United States
url: https://www.covidplasmastudy.com/
description: Website to register participants for the study
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: COVID-19
mesh term: Laboratory Infection