<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/NCT04408040</url>
  </required_header>
  <id_info>
    <org_study_id>NSH 1281</org_study_id>
    <nct_id>NCT04408040</nct_id>
  </id_info>
  <brief_title>Use of Convalescent Plasma for COVID-19</brief_title>
  <official_title>Use of Convalescent Plasma Collected From Donors Recovered From COVID-19 Virus Disease for Transfusion, as an Empirical and Preemptive Treatment During Viral Pandemic Outbreak</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northside Hospital, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northside Hospital, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The plan is to transfuse COVID-19 infected patients with convalescent plasma and observe&#xD;
      whether this will result in a significant improvement in clinical outcome in comparison to&#xD;
      historical experience.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    New information regarding use of plasma in covid + patients&#xD;
  </why_stopped>
  <start_date type="Actual">July 14, 2020</start_date>
  <completion_date type="Actual">September 14, 2021</completion_date>
  <primary_completion_date type="Actual">September 14, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Arms 1 &amp; 2: Number of COVID-19 Infected Patients in Severe, High Risk &amp; Health Care Provider Cohorts Who Survive the Infection</measure>
    <time_frame>30 days after initial treatment</time_frame>
    <description>Number of patients who survived the covid infection after treatment on study.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Critical Patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe Patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High Risk</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Health Care Providers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Convalescent Plasma</intervention_name>
    <description>200-425mL convalescent plasma donated by patients previously positive for COVID-19</description>
    <arm_group_label>Critical Patients</arm_group_label>
    <arm_group_label>Health Care Providers</arm_group_label>
    <arm_group_label>High Risk</arm_group_label>
    <arm_group_label>Severe Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented COVID-19 infection by nasal pharyngeal sampling&#xD;
&#xD;
          -  COVID-19 disease falling into one of the following groups:&#xD;
&#xD;
          -  Critical disease: respiratory failure requiring mechanical ventilation, pressor&#xD;
             support, or multiple organ dysfunction/failure&#xD;
&#xD;
          -  Severe disease: tachypnea &gt;/=30 per min, O2 sats &lt;/=93% at rest, PaO2/FiO2 index&#xD;
             &lt;/=300mmHg&#xD;
&#xD;
          -  High Risk: upper respiratory symptoms but no radiographic evidence of disease,&#xD;
             immunocompromised, insulin-dependent diabetes, poorly controlled HIV disease, moderate&#xD;
             to severe asthma history, severe COPD, morbid obesity (BMI &gt;/=40, age &gt;/=65 years&#xD;
&#xD;
          -  Health Care Providers: health care providers at risk to exposure to COVID-19 infection&#xD;
             or those with mild to non-severe disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of IgA deficiency&#xD;
&#xD;
          -  History of anaphylatic reaction to blood product transfusion including&#xD;
             hypersensitivity to immunoglobulin therapy&#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>Kent Holland, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northside Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northside Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <results_first_submitted>November 23, 2021</results_first_submitted>
  <results_first_submitted_qc>October 19, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 14, 2022</results_first_posted>
  <last_update_submitted>October 19, 2022</last_update_submitted>
  <last_update_submitted_qc>October 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>December 7, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT04408040/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Enrollment period 7/14/2020-9/13/2021 Subjects were recruited from the hospital, outpatient clinic and from marketing efforts</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Critical Patients</title>
          <description>Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19</description>
        </group>
        <group group_id="P2">
          <title>Severe Patients</title>
          <description>Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19</description>
        </group>
        <group group_id="P3">
          <title>High Risk</title>
          <description>Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19</description>
        </group>
        <group group_id="P4">
          <title>Health Care Providers</title>
          <description>Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>No critical patients were consented for this study</population>
      <group_list>
        <group group_id="B1">
          <title>Critical Patients</title>
          <description>Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19</description>
        </group>
        <group group_id="B2">
          <title>Severe Patients</title>
          <description>Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19</description>
        </group>
        <group group_id="B3">
          <title>High Risk</title>
          <description>Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19</description>
        </group>
        <group group_id="B4">
          <title>Health Care Providers</title>
          <description>Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19</description>
        </group>
        <group group_id="B5">
          <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="0"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="1"/>
            <count group_id="B5" value="8"/>
          </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="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="63" lower_limit="63" upper_limit="63"/>
                    <measurement group_id="B3" value="37" lower_limit="27" upper_limit="72"/>
                    <measurement group_id="B4" value="25" lower_limit="25" upper_limit="25"/>
                    <measurement group_id="B5" value="37" lower_limit="25" upper_limit="72"/>
                  </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="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" 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="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </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="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Arms 1 &amp; 2: Number of COVID-19 Infected Patients in Severe, High Risk &amp; Health Care Provider Cohorts Who Survive the Infection</title>
        <description>Number of patients who survived the covid infection after treatment on study.</description>
        <time_frame>30 days after initial treatment</time_frame>
        <population>no critical patients were enrolled.</population>
        <group_list>
          <group group_id="O1">
            <title>Critical Patients</title>
            <description>Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19</description>
          </group>
          <group group_id="O2">
            <title>Severe Patients</title>
            <description>Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19</description>
          </group>
          <group group_id="O3">
            <title>High Risk</title>
            <description>Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19</description>
          </group>
          <group group_id="O4">
            <title>Health Care Providers</title>
            <description>Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19</description>
          </group>
        </group_list>
        <measure>
          <title>Arms 1 &amp; 2: Number of COVID-19 Infected Patients in Severe, High Risk &amp; Health Care Provider Cohorts Who Survive the Infection</title>
          <description>Number of patients who survived the covid infection after treatment on study.</description>
          <population>no critical patients were enrolled.</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="0"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days</time_frame>
      <desc>8 patients assessed</desc>
      <group_list>
        <group group_id="E1">
          <title>Critical Patients</title>
          <description>Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19</description>
        </group>
        <group group_id="E2">
          <title>Severe Patients</title>
          <description>Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19</description>
        </group>
        <group group_id="E3">
          <title>High Risk</title>
          <description>Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19</description>
        </group>
        <group group_id="E4">
          <title>Health Care Providers</title>
          <description>Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>H. Kent Holland, MD</name_or_title>
      <organization>Northside Hospital</organization>
      <phone>404-255-1930</phone>
      <email>kholland@bmtga.com</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/NCT04408040
org study id: NSH 1281
nct id: NCT04408040
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The plan is to transfuse COVID-19 infected patients with convalescent plasma and observe
      whether this will result in a significant improvement in clinical outcome in comparison to
      historical experience.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Arms 1 & 2: Number of COVID-19 Infected Patients in Severe, High Risk & Health Care Provider Cohorts Who Survive the Infection
time frame: 30 days after initial treatment
description: Number of patients who survived the covid infection after treatment on study.
arm group label: Critical Patients
arm group type: Other
arm group label: Severe Patients
arm group type: Other
arm group label: High Risk
arm group type: Other
arm group label: Health Care Providers
arm group type: Other
intervention type: Biological
intervention name: Convalescent Plasma
description: 200-425mL convalescent plasma donated by patients previously positive for COVID-19
arm group label: Critical Patients
arm group label: Health Care Providers
arm group label: High Risk
arm group label: Severe Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kent Holland, MD
role: Principal Investigator
affiliation: Northside Hospital
facility: 
country: United States
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 