<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/NCT04471051</url>
  </required_header>
  <id_info>
    <org_study_id>20-0986</org_study_id>
    <nct_id>NCT04471051</nct_id>
  </id_info>
  <brief_title>An Observational Cohort Trial of Outcomes and Antibody Responses Following Treatment With COVID19 Convalescent Plasma in Hospitalized COVID-19 Patients</brief_title>
  <official_title>An Observational Cohort Trial of Outcomes and Antibody Responses Following Treatment With COVID19 Convalescent Plasma in Hospitalized COVID-19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <brief_summary>
    <textblock>
      This is an observational study designed to learn more about how COVID19 convalescent plasma&#xD;
      works in patients with COVID19 compared to those patients who did not receive convalescent&#xD;
      plasma treatment. Information about patient recovery will be collected from participants'&#xD;
      electronic medical records to evaluate safety, clinical outcomes, and SARS-CoV2 antibody&#xD;
      responses in patients who were treated with convalescent plasma under a separate expanded&#xD;
      access protocol, NCT04372368.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This a prospective, observational cohort trial to evaluate safety, clinical outcomes, and&#xD;
      SARS-CoV2 antibody responses in patients who were treated with anti-SARS-CoV-2 convalescent&#xD;
      plasma under Expanded Access protocol, NCT04372368. Hospitalized patients with acute&#xD;
      respiratory symptoms with or without confirmed interstitial COVID-19 pneumonia will be&#xD;
      enrolled. The investigators anticipate that a minimum of 150 eligible subjects will be&#xD;
      enrolled to receive COVID19 convalescent plasma over the 12 month period for the FDA IND&#xD;
      expanded access protocol, NCT04372368, to provide COVID19 convalescent serum, which is a&#xD;
      separate treatment trial. This observational protocol will co-enroll patients in parallel&#xD;
      with the expanded access protocol and expects to enroll approximately the same number of&#xD;
      patients but no treatment will be provided as part of this protocol. Additionally, the&#xD;
      investigators will use Compass data with identifiers to pull information on hospitalized&#xD;
      control COVID19+ patients from hospital admission date 4/20 to current for comparison.&#xD;
&#xD;
      This protocol is limited to data collection using the EMR to evaluate outcomes following&#xD;
      COVID19 convalescent plasma treatment. Patient-linked specimens will not be obtained and&#xD;
      analyzed outside of the expanded access protocol for distribution of COVID19 convalescent&#xD;
      plasma. For this protocol, only de-identified, discarded samples may be obtained during&#xD;
      routine patient care. Thus, consent will only be obtained from patients/subjects for&#xD;
      participation in data abstraction/analysis from the electronic medical record.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 30, 2020</start_date>
  <completion_date type="Actual">August 20, 2020</completion_date>
  <primary_completion_date type="Actual">August 20, 2020</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>Inpatient Mortality</measure>
    <time_frame>Hospital admission up to Day 28 or discharge</time_frame>
    <description>Overall Inpatient Mortality</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Requirement for mechanical ventilation</measure>
    <time_frame>Hospital admission up to Day 28 or discharge</time_frame>
    <description>Number of patients requiring mechanical ventilation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Transfer to ICU</measure>
    <time_frame>Hospital admission up to Day 28 or discharge</time_frame>
    <description>Number of patients transferred to an Intensive Care Unit (ICU)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ICU Mortality</measure>
    <time_frame>Hospital admission up to Day 28 or discharge</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>ICU Length of Stay (LOS)</measure>
    <time_frame>Hospital admission up to Day 28 or discharge</time_frame>
    <description>LOS, measured in days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital Mortality</measure>
    <time_frame>Hospital admission up to Day 28 or discharge</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital Length of Stay (LOS)</measure>
    <time_frame>Hospital admission up to Day 28 or discharge</time_frame>
    <description>LOS, measured in days</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">255</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>COVID19 Convalescent Plasma Treatment</arm_group_label>
    <description>Hospitalized COVID19 patients who receive COVID19 Convalescent Plasma under Expanded Access protocol NCT04372368.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized patients treated with anti-SARS-CoV-2 convalescent plasma under the Expanded&#xD;
        Access protocol NCT04372368. Patients with acute respiratory symptoms with or without&#xD;
        confirmed interstitial COVID-19 pneumonia will be enrolled. This observational protocol&#xD;
        will co-enroll patients in parallel with the expanded access protocol and expects to enroll&#xD;
        approximately the same number of patients but no treatment will be provided as part of this&#xD;
        protocol.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19&#xD;
             SARS-CoV-2 RT-PCR testing.&#xD;
&#xD;
          -  Patient treated with COVID19 convalescent plasma.&#xD;
&#xD;
          -  Patient or surrogate designated decision maker is willing and able to provide written&#xD;
             informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receipt of pooled immunoglobulin in past 30 days&#xD;
&#xD;
          -  Contraindication to transfusion or history of prior reactions to transfusion blood&#xD;
             products&#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>John D Beckham, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCHealth Memorial Hospital North</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Denver Health Medical Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCHealth Poudre Valley Hospital</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80524</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCHealth Highlands Ranch Hospital</name>
      <address>
        <city>Highlands Ranch</city>
        <state>Colorado</state>
        <zip>80129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>June 8, 2021</last_update_submitted>
  <last_update_submitted_qc>June 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Coronavirus</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>convalescent plasma</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>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/NCT04471051
org study id: 20-0986
nct id: NCT04471051
lead sponsor: 
This is an observational study designed to learn more about how COVID19 convalescent plasma
      works in patients with COVID19 compared to those patients who did not receive convalescent
      plasma treatment. Information about patient recovery will be collected from participants'
      electronic medical records to evaluate safety, clinical outcomes, and SARS-CoV2 antibody
      responses in patients who were treated with convalescent plasma under a separate expanded
      access protocol, NCT04372368.
This a prospective, observational cohort trial to evaluate safety, clinical outcomes, and
      SARS-CoV2 antibody responses in patients who were treated with anti-SARS-CoV-2 convalescent
      plasma under Expanded Access protocol, NCT04372368. Hospitalized patients with acute
      respiratory symptoms with or without confirmed interstitial COVID-19 pneumonia will be
      enrolled. The investigators anticipate that a minimum of 150 eligible subjects will be
      enrolled to receive COVID19 convalescent plasma over the 12 month period for the FDA IND
      expanded access protocol, NCT04372368, to provide COVID19 convalescent serum, which is a
      separate treatment trial. This observational protocol will co-enroll patients in parallel
      with the expanded access protocol and expects to enroll approximately the same number of
      patients but no treatment will be provided as part of this protocol. Additionally, the
      investigators will use Compass data with identifiers to pull information on hospitalized
      control COVID19+ patients from hospital admission date 4/20 to current for comparison.

      This protocol is limited to data collection using the EMR to evaluate outcomes following
      COVID19 convalescent plasma treatment. Patient-linked specimens will not be obtained and
      analyzed outside of the expanded access protocol for distribution of COVID19 convalescent
      plasma. For this protocol, only de-identified, discarded samples may be obtained during
      routine patient care. Thus, consent will only be obtained from patients/subjects for
      participation in data abstraction/analysis from the electronic medical record.
observational model: Cohort
time perspective: Prospective
measure: Inpatient Mortality
time frame: Hospital admission up to Day 28 or discharge
description: Overall Inpatient Mortality
measure: Requirement for mechanical ventilation
time frame: Hospital admission up to Day 28 or discharge
description: Number of patients requiring mechanical ventilation
measure: Transfer to ICU
time frame: Hospital admission up to Day 28 or discharge
description: Number of patients transferred to an Intensive Care Unit (ICU)
measure: ICU Mortality
time frame: Hospital admission up to Day 28 or discharge
measure: ICU Length of Stay (LOS)
time frame: Hospital admission up to Day 28 or discharge
description: LOS, measured in days
measure: Hospital Mortality
time frame: Hospital admission up to Day 28 or discharge
measure: Hospital Length of Stay (LOS)
time frame: Hospital admission up to Day 28 or discharge
description: LOS, measured in days
arm group label: COVID19 Convalescent Plasma Treatment
description: Hospitalized COVID19 patients who receive COVID19 Convalescent Plasma under Expanded Access protocol NCT04372368.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John D Beckham, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No