<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/NCT04502472</url>
  </required_header>
  <id_info>
    <org_study_id>Inova COVID-19 CCP</org_study_id>
    <nct_id>NCT04502472</nct_id>
  </id_info>
  <brief_title>Treatment of Severe Coronavirus Disease 2019 (COVID-19) With Convalescent Plasma</brief_title>
  <acronym>Inova-CCP</acronym>
  <official_title>Treatment of Severe Coronavirus Disease 2019 (COVID-19) With Convalescent Plasma Collected From Individuals With Documented Infection and Recovery From COVID-19 (SARS-CoV-2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inova Health Care Services</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inova Health Care Services</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that use of convalescent plasma donated from individuals&#xD;
      recovered from Coronavirus Disease 2019 (COVID-19) will help expedite recovery of individuals&#xD;
      with active, severe COVID-19 infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this research study is to see if convalescent plasma is safe and effective for&#xD;
      the treatment of patients acutely ill with COVID-19. The researchers want to confirm the&#xD;
      right dose levels of immunoglobulins/antibodies (immune proteins) and find out what&#xD;
      therapeutic effects plasma donated by recovered individuals has on people severely sick with&#xD;
      COVID-19.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    FDA gave emergency use approval to COVID-19 convalescent plasma on 08/24/2020&#xD;
  </why_stopped>
  <start_date type="Actual">June 6, 2020</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Phase 1 will be recruitment and enrollment of plasma donors. Phase 2 will be continued recruitment and enrollment of plasma donors, with the addition of recruitment and enrollment of plasma recipients.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change is Clinical Status</measure>
    <time_frame>Time of plasma infusion (day 0) compared to day 7</time_frame>
    <description>Change is clinical status as captured by 7-point ordinal scale to include&#xD;
Death&#xD;
Hospitalized, requiring mechanical ventilation or ECMO&#xD;
Hospitalized, requiring non-invasive ventilation or high flow oxygen&#xD;
Hospitalized, requiring supplemental oxygen&#xD;
Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise)&#xD;
Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise).&#xD;
Not Hospitalized</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Transfusion Related Events Due to Administration of CCP</measure>
    <time_frame>Within 6 hours of infusion</time_frame>
    <description>Number of participants with Transfusion Related Adverse Events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change is Clinical Status</measure>
    <time_frame>Time of plasma infusion (day 0 prior to first infusion) to days 7,14, 21, and 28</time_frame>
    <description>Change in 7-point ordinal scale score from time of plasma infusion (day 0-prior to first infusion) to days 7, 14, 21, and 28.&#xD;
7 point ordinal scale:&#xD;
Death&#xD;
Hospitalized, requiring mechanical ventilation or ECMO&#xD;
Hospitalized, requiring non-invasive ventilation or high flow oxygen&#xD;
Hospitalized, requiring supplemental oxygen&#xD;
Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise)&#xD;
Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise).&#xD;
Not Hospitalized</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>Total Index Hospitalization</time_frame>
    <description>Total duration of hospital stay which includes from Admission with COVID-19 from admission with COVID-19 symptoms to discharge or death (up to an average of 67 days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical Ventilation</measure>
    <time_frame>Days 7, 14, 21, 28</time_frame>
    <description>Number of participants that required mechanical ventilation that were not on mechanical ventilation at that time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mechanical Ventilation Status</measure>
    <time_frame>Day 0 (date of CCP transfusion) to Day 28</time_frame>
    <description>Number of participants who required a change in the mechanical ventilation status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>From Day of Transfusion (Day 0) to Day 28 post-transfusion for patients who received CCP. Patients who donated CCP were not followed for a defined time period after CCP donation.</time_frame>
    <description>All-cause Mortality</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Covid-19</condition>
  <arm_group>
    <arm_group_label>Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Convalescent plasma transfusion</intervention_name>
    <description>Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome.</description>
    <arm_group_label>Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Phase 1 Inclusion Criteria:&#xD;
&#xD;
        Inclusion Criteria for Convalescent Plasma Donors:&#xD;
&#xD;
        - Outpatients 18 years old and older who have recovered from COVID-19:&#xD;
&#xD;
          -  Have proof of Original Positive SARS-CoV-2 NAT nasopharyngeal (NP) test result&#xD;
&#xD;
          -  Complete resolution of symptoms at least 14 days prior to donation&#xD;
&#xD;
          -  Negative SARS-CoV-2 NAT nasopharyngeal (NP) specimen at screening visit&#xD;
&#xD;
          -  Able to meet standard criteria for blood donation&#xD;
&#xD;
          -  Clinically stable based on provider assessment&#xD;
&#xD;
        Phase 1 Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Inability to complete or contraindication to donation based on Donor History -&#xD;
&#xD;
          -  Questionnaire (DHQ), FDA approved standard blood donation form&#xD;
&#xD;
          -  Hb&lt;13.0 g/dL for males&#xD;
&#xD;
          -  Hb&lt;12.5 g/dL for females&#xD;
&#xD;
          -  History of 3 more pregnancies unless HLA antibody testing is performed and deemed&#xD;
             acceptable by director of blood donor services (to reduce risks of transfusion Related&#xD;
             Acute Lung Injury in recipients). The presence of any transfusion transmitted diseases&#xD;
             is based on history or test results from blood sample collected from the donor at time&#xD;
             of plasma collection in accordance to standard practice.&#xD;
&#xD;
          -  Female subjects who are pregnant by self-report.&#xD;
&#xD;
          -  Receipt of pooled immunoglobulin in past 30 days&#xD;
&#xD;
        PHASE 2: Inclusion Criteria for Recipients of COVID-19 Convalescent Plasma:&#xD;
&#xD;
          -  Patients in the Inova Health System with confirmed COVID-19 by PCR testing&#xD;
&#xD;
          -  Age ≥ 13 years&#xD;
&#xD;
          -  Currently hospitalized with COVID-19 infection with severe or life-threatening&#xD;
             clinical syndrome as follows:&#xD;
&#xD;
          -  Severe COVID-19: (three or more of the following)&#xD;
&#xD;
               -  Dyspnea&#xD;
&#xD;
               -  Respiratory rate ≥ 30/min&#xD;
&#xD;
               -  Blood oxygen saturation (SpO2) ≤ 94% on room air&#xD;
&#xD;
               -  Partial pressure of arterial oxygen to fraction of inspired oxygen (P:F) ratio &lt;&#xD;
                  300&#xD;
&#xD;
               -  Pulmonary infiltrates &gt; 50% of lung parenchyma within 24 to 48 hours&#xD;
&#xD;
          -  Life-threatening disease is defined as: (one of the following)&#xD;
&#xD;
               -  Respiratory failure&#xD;
&#xD;
               -  Septic shock, and/or&#xD;
&#xD;
               -  Multiple organ dysfunction or failure&#xD;
&#xD;
          -  Patient must provide informed consent or have health care power of attorney/next of&#xD;
             kin provide consent if he/she cannot.&#xD;
&#xD;
        PHASE 2 Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to receive plasma as deemed by the treating physician&#xD;
&#xD;
          -  Severe hypercoagulable state (documented in medical chart or by treating physician&#xD;
             assessment)&#xD;
&#xD;
          -  Absolute IgA deficiency&#xD;
&#xD;
          -  Prior history of Transfusion Related Acute Lung Injury (TRALI)&#xD;
&#xD;
          -  Inability to tolerate plasma volume due to severe systolic or diastolic heart failure&#xD;
             despite slower infusion and diuretic administration&#xD;
&#xD;
          -  Positive pregnancy test (HCG)&#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>Anne Brown, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inova Health Care Services</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inova Fairfax Medical Campus</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
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    <citation>Soo YO, Cheng Y, Wong R, Hui DS, Lee CK, Tsang KK, Ng MH, Chan P, Cheng G, Sung JJ. Retrospective comparison of convalescent plasma with continuing high-dose methylprednisolone treatment in SARS patients. Clin Microbiol Infect. 2004 Jul;10(7):676-8. doi: 10.1111/j.1469-0691.2004.00956.x.</citation>
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    <citation>van Griensven J, Edwards T, Baize S; Ebola-Tx Consortium. Efficacy of Convalescent Plasma in Relation to Dose of Ebola Virus Antibodies. N Engl J Med. 2016 Dec 8;375(23):2307-2309. doi: 10.1056/NEJMc1609116. Epub 2016 Nov 14. No abstract available.</citation>
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    <citation>WHO. Use of convalescent whole blood or plasma collected from patients recovered from Ebola virus disease for transfusion, as an empirical treatment during outbreaks. 2014 http://apps.who.int/iris/rest/bitstreams/604045/retrieve (accessed 3/27/2020).</citation>
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    <citation>WHO. Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected 2020. https://www.who.int/docs/default-source/coronaviruse/clinical-management-of-novel-cov.pdf (accessed 3/27/20).</citation>
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    <citation>Chen L, Xiong J, Bao L, Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020 Apr;20(4):398-400. doi: 10.1016/S1473-3099(20)30141-9. Epub 2020 Feb 27. No abstract available.</citation>
    <PMID>32113510</PMID>
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    <citation>Lauer SA, Grantz KH, Bi Q, Jones FK, Zheng Q, Meredith HR, Azman AS, Reich NG, Lessler J. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Ann Intern Med. 2020 May 5;172(9):577-582. doi: 10.7326/M20-0504. Epub 2020 Mar 10.</citation>
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    <citation>Amanat F, Stadlbauer D, Strohmeier S, Nguyen THO, Chromikova V, McMahon M, Jiang K, Arunkumar GA, Jurczyszak D, Polanco J, Bermudez-Gonzalez M, Kleiner G, Aydillo T, Miorin L, Fierer DS, Lugo LA, Kojic EM, Stoever J, Liu STH, Cunningham-Rundles C, Felgner PL, Moran T, Garcia-Sastre A, Caplivski D, Cheng AC, Kedzierska K, Vapalahti O, Hepojoki JM, Simon V, Krammer F. A serological assay to detect SARS-CoV-2 seroconversion in humans. Nat Med. 2020 Jul;26(7):1033-1036. doi: 10.1038/s41591-020-0913-5. Epub 2020 May 12.</citation>
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    <citation>Epstein J, Burnouf T. Points to consider in the preparation and transfusion of COVID-19 convalescent plasma. Vox Sang. 2020 Aug;115(6):485-487. doi: 10.1111/vox.12939. Epub 2020 May 14. No abstract available.</citation>
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    <citation>Beigel JH, Tebas P, Elie-Turenne MC, Bajwa E, Bell TE, Cairns CB, Shoham S, Deville JG, Feucht E, Feinberg J, Luke T, Raviprakash K, Danko J, O'Neil D, Metcalf JA, King K, Burgess TH, Aga E, Lane HC, Hughes MD, Davey RT; IRC002 Study Team. Immune plasma for the treatment of severe influenza: an open-label, multicentre, phase 2 randomised study. Lancet Respir Med. 2017 Jun;5(6):500-511. doi: 10.1016/S2213-2600(17)30174-1. Epub 2017 May 15. Erratum In: Lancet Respir Med. 2017 Jul;5(7):e26.</citation>
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    <citation>Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.</citation>
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    <citation>Pandey S, Vyas GN. Adverse effects of plasma transfusion. Transfusion. 2012 May;52 Suppl 1(Suppl 1):65S-79S. doi: 10.1111/j.1537-2995.2012.03663.x.</citation>
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  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <results_first_submitted>October 4, 2021</results_first_submitted>
  <results_first_submitted_qc>January 5, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 10, 2022</results_first_posted>
  <last_update_submitted>January 5, 2022</last_update_submitted>
  <last_update_submitted_qc>January 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 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>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 19, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT04502472/Prot_SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>COVID-19 Convalescent Plasma (CCP) Donors</title>
          <description>Patients recovered from COVID-19 and donated CCP through the study.</description>
        </group>
        <group group_id="P2">
          <title>COVID-19 Convalescent Plasma (CCP Recipients)</title>
          <description>Patients who were hospitalized with COVID-19 and received CCP infusions through the study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion</title>
          <description>Patients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria&#xD;
Convalescent plasma transfusion: Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome.</description>
        </group>
        <group group_id="B2">
          <title>Donor of COVID-19 Convalescent Plasma (CCP)</title>
          <description>Patients who recovered from COVID-19 infection and test negative for COVID-19 by nasopharyngeal swab.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="48"/>
            <count group_id="B2" value="61"/>
            <count group_id="B3" value="109"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="85"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59" lower_limit="16" upper_limit="87"/>
                    <measurement group_id="B2" value="48" lower_limit="18" upper_limit="80"/>
                    <measurement group_id="B3" value="53" lower_limit="16" upper_limit="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change is Clinical Status</title>
        <description>Change is clinical status as captured by 7-point ordinal scale to include&#xD;
Death&#xD;
Hospitalized, requiring mechanical ventilation or ECMO&#xD;
Hospitalized, requiring non-invasive ventilation or high flow oxygen&#xD;
Hospitalized, requiring supplemental oxygen&#xD;
Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise)&#xD;
Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise).&#xD;
Not Hospitalized</description>
        <time_frame>Time of plasma infusion (day 0) compared to day 7</time_frame>
        <population>Patients that were hospitalized with COVID-19 and received CCP were evaluated using the 7-point ordinal scale. The worse oxygenation status was used for day 0 and day 7.</population>
        <group_list>
          <group group_id="O1">
            <title>Patients Hospitalized With COVID-19</title>
            <description>45 patients were hospitalized with COVID-19 and received CCP through the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change is Clinical Status</title>
          <description>Change is clinical status as captured by 7-point ordinal scale to include&#xD;
Death&#xD;
Hospitalized, requiring mechanical ventilation or ECMO&#xD;
Hospitalized, requiring non-invasive ventilation or high flow oxygen&#xD;
Hospitalized, requiring supplemental oxygen&#xD;
Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise)&#xD;
Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise).&#xD;
Not Hospitalized</description>
          <population>Patients that were hospitalized with COVID-19 and received CCP were evaluated using the 7-point ordinal scale. The worse oxygenation status was used for day 0 and day 7.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Average Day 1 Ordinal Scale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.06" lower_limit="1" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average Day 7 Ordinal Scale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.86" lower_limit="1" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Transfusion Related Events Due to Administration of CCP</title>
        <description>Number of participants with Transfusion Related Adverse Events</description>
        <time_frame>Within 6 hours of infusion</time_frame>
        <population>Transfusion related events were only measured in the convalescent plasma recipient arm. 48 patients were enrolled in the study. 45 received CCP. 3 patients received CCP through individual INDs.&#xD;
This outcome measure was only for patients who were hospitalized with COVID-19 and received CCP through the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Patients Hospitalized With COVID-19</title>
            <description>45 patients were hospitalized with COVID-19 and received CCP through the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Transfusion Related Events Due to Administration of CCP</title>
          <description>Number of participants with Transfusion Related Adverse Events</description>
          <population>Transfusion related events were only measured in the convalescent plasma recipient arm. 48 patients were enrolled in the study. 45 received CCP. 3 patients received CCP through individual INDs.&#xD;
This outcome measure was only for patients who were hospitalized with COVID-19 and received CCP through the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change is Clinical Status</title>
        <description>Change in 7-point ordinal scale score from time of plasma infusion (day 0-prior to first infusion) to days 7, 14, 21, and 28.&#xD;
7 point ordinal scale:&#xD;
Death&#xD;
Hospitalized, requiring mechanical ventilation or ECMO&#xD;
Hospitalized, requiring non-invasive ventilation or high flow oxygen&#xD;
Hospitalized, requiring supplemental oxygen&#xD;
Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise)&#xD;
Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise).&#xD;
Not Hospitalized</description>
        <time_frame>Time of plasma infusion (day 0 prior to first infusion) to days 7,14, 21, and 28</time_frame>
        <population>Patients ts that were hospitalized with COVID-19 and received CCP were evaluated using the 7-point ordinal scale. The worse oxygenation status was used for days 7, 14, 21, and 28</population>
        <group_list>
          <group group_id="O1">
            <title>Patients Hospitalized With COVID-19</title>
            <description>45 patients were hospitalized with COVID-19 and received CCP through the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change is Clinical Status</title>
          <description>Change in 7-point ordinal scale score from time of plasma infusion (day 0-prior to first infusion) to days 7, 14, 21, and 28.&#xD;
7 point ordinal scale:&#xD;
Death&#xD;
Hospitalized, requiring mechanical ventilation or ECMO&#xD;
Hospitalized, requiring non-invasive ventilation or high flow oxygen&#xD;
Hospitalized, requiring supplemental oxygen&#xD;
Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise)&#xD;
Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise).&#xD;
Not Hospitalized</description>
          <population>Patients ts that were hospitalized with COVID-19 and received CCP were evaluated using the 7-point ordinal scale. The worse oxygenation status was used for days 7, 14, 21, and 28</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ordinal Scale Day 0</title>
              <category_list>
                <category>
                  <title>Ordinal Scale 2 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 3 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 4 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 5 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 6 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 7 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 1 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ordinal Scale Day 7</title>
              <category_list>
                <category>
                  <title>Ordinal Scale 2 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 3 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 4 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 5 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 6 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 7 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 1 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ordinal Scale Day 14</title>
              <category_list>
                <category>
                  <title>Ordinal Scale 2 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 3 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 4 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 5 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 6 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 7 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 1 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ordinal Scale Day 21</title>
              <category_list>
                <category>
                  <title>Ordinal Scale 2 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 3 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 4 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 5 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 6 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 7 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 1 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ordinal Scale Day 28</title>
              <category_list>
                <category>
                  <title>Ordinal Scale 2 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 3 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 4 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 5 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 6 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 7 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ordinal Scale 1 out of 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Hospital Stay</title>
        <description>Total duration of hospital stay which includes from Admission with COVID-19 from admission with COVID-19 symptoms to discharge or death (up to an average of 67 days)</description>
        <time_frame>Total Index Hospitalization</time_frame>
        <population>Total duration of hospital stay which includes from Admission with COVID-19 from admission with COVID-19 symptoms to discharge or death</population>
        <group_list>
          <group group_id="O1">
            <title>Patients Hospitalized With COVID-19</title>
            <description>45 patients were hospitalized with COVID-19 and received CCP through the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospital Stay</title>
          <description>Total duration of hospital stay which includes from Admission with COVID-19 from admission with COVID-19 symptoms to discharge or death (up to an average of 67 days)</description>
          <population>Total duration of hospital stay which includes from Admission with COVID-19 from admission with COVID-19 symptoms to discharge or death</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" lower_limit="4" upper_limit="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mechanical Ventilation</title>
        <description>Number of participants that required mechanical ventilation that were not on mechanical ventilation at that time point.</description>
        <time_frame>Days 7, 14, 21, 28</time_frame>
        <population>The count of participants below shows the total number of participants needing mechanical ventilation for that time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion</title>
            <description>Patients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria&#xD;
Convalescent plasma transfusion: Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome.</description>
          </group>
        </group_list>
        <measure>
          <title>Mechanical Ventilation</title>
          <description>Number of participants that required mechanical ventilation that were not on mechanical ventilation at that time point.</description>
          <population>The count of participants below shows the total number of participants needing mechanical ventilation for that time point.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7</title>
              <category_list>
                <category>
                  <title>Patients requiring mechanical ventilation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patients not requiring mechanical ventilation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patients deceased</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patients discharged</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <category_list>
                <category>
                  <title>Patients requiring mechanical ventilation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patients not requiring mechanical ventilation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patients deceased</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patients discharged</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <category_list>
                <category>
                  <title>Patients requiring mechanical ventilation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patients not requiring mechanical ventilation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patients deceased</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patients discharged</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <category_list>
                <category>
                  <title>Patients requiring mechanical ventilation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patients not requiring mechanical ventilation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patients deceased</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patients discharged</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mechanical Ventilation Status</title>
        <description>Number of participants who required a change in the mechanical ventilation status</description>
        <time_frame>Day 0 (date of CCP transfusion) to Day 28</time_frame>
        <population>Patients that were hospitalized with COVID-19 and received CCP through the study</population>
        <group_list>
          <group group_id="O1">
            <title>Patients Hospitalized With COVID-19</title>
            <description>45 patients were analyzed</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mechanical Ventilation Status</title>
          <description>Number of participants who required a change in the mechanical ventilation status</description>
          <population>Patients that were hospitalized with COVID-19 and received CCP through the study</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mortality</title>
        <description>All-cause Mortality</description>
        <time_frame>From Day of Transfusion (Day 0) to Day 28 post-transfusion for patients who received CCP. Patients who donated CCP were not followed for a defined time period after CCP donation.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Patients Hospitalized With COVID-19</title>
            <description>45 patients were hospitalized with COVID-19 and received CCP through the study.</description>
          </group>
          <group group_id="O2">
            <title>Patients Recovered From COVID-19</title>
            <description>patients who donated CCP</description>
          </group>
        </group_list>
        <measure>
          <title>Mortality</title>
          <description>All-cause Mortality</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Patients were monitored for up to 67 days</time_frame>
      <desc>Only serious adverse events were recorded.</desc>
      <group_list>
        <group group_id="E1">
          <title>Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion</title>
          <description>Patients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria&#xD;
Convalescent plasma transfusion: Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome.&#xD;
Adverse Events only monitored/assessed in Convalescent Plasma Recipients.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>transfusion reaction</sub_title>
                <description>3 patients had a transfusion reaction due to CCP.</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <description>14 patients died during the study.</description>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Intubation</sub_title>
                <description>4 patients were intubated during the course of the study that recovered.</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Anne Whitney Brown, MD</name_or_title>
      <organization>Inova Health Systems</organization>
      <phone>7037763067</phone>
      <email>anne.brown@inova.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04502472
org study id: Inova COVID-19 CCP
nct id: NCT04502472
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The investigators hypothesize that use of convalescent plasma donated from individuals
      recovered from Coronavirus Disease 2019 (COVID-19) will help expedite recovery of individuals
      with active, severe COVID-19 infection.
The purpose of this research study is to see if convalescent plasma is safe and effective for
      the treatment of patients acutely ill with COVID-19. The researchers want to confirm the
      right dose levels of immunoglobulins/antibodies (immune proteins) and find out what
      therapeutic effects plasma donated by recovered individuals has on people severely sick with
      COVID-19.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Phase 1 will be recruitment and enrollment of plasma donors. Phase 2 will be continued recruitment and enrollment of plasma donors, with the addition of recruitment and enrollment of plasma recipients.
primary purpose: Treatment
masking: None (Open Label)
measure: Change is Clinical Status
time frame: Time of plasma infusion (day 0) compared to day 7
description: Change is clinical status as captured by 7-point ordinal scale to include
Death
Hospitalized, requiring mechanical ventilation or ECMO
Hospitalized, requiring non-invasive ventilation or high flow oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise)
Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise).
Not Hospitalized
measure: Transfusion Related Events Due to Administration of CCP
time frame: Within 6 hours of infusion
description: Number of participants with Transfusion Related Adverse Events
measure: Change is Clinical Status
time frame: Time of plasma infusion (day 0 prior to first infusion) to days 7,14, 21, and 28
description: Change in 7-point ordinal scale score from time of plasma infusion (day 0-prior to first infusion) to days 7, 14, 21, and 28.
7 point ordinal scale:
Death
Hospitalized, requiring mechanical ventilation or ECMO
Hospitalized, requiring non-invasive ventilation or high flow oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise)
Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise).
Not Hospitalized
measure: Length of Hospital Stay
time frame: Total Index Hospitalization
description: Total duration of hospital stay which includes from Admission with COVID-19 from admission with COVID-19 symptoms to discharge or death (up to an average of 67 days)
measure: Mechanical Ventilation
time frame: Days 7, 14, 21, 28
description: Number of participants that required mechanical ventilation that were not on mechanical ventilation at that time point.
measure: Change in Mechanical Ventilation Status
time frame: Day 0 (date of CCP transfusion) to Day 28
description: Number of participants who required a change in the mechanical ventilation status
measure: Mortality
time frame: From Day of Transfusion (Day 0) to Day 28 post-transfusion for patients who received CCP. Patients who donated CCP were not followed for a defined time period after CCP donation.
description: All-cause Mortality
arm group label: Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion
arm group type: Experimental
description: Patients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria
intervention type: Biological
intervention name: Convalescent plasma transfusion
description: Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome.
arm group label: Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anne Brown, M.D.
role: Principal Investigator
affiliation: Inova Health Care Services
facility: 
country: United States
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responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 