<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/NCT04411667</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-IVIG</org_study_id>
    <secondary_id>2004902</secondary_id>
    <nct_id>NCT04411667</nct_id>
  </id_info>
  <brief_title>Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19</brief_title>
  <official_title>Randomized Open Label Study of Standard of Care Plus Intravenous Immunoglobulin (IVIG) Compared to Standard of Care Alone in the Treatment of COVID-19 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>George Sakoulas, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Octapharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sharp HealthCare</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to see if Intravenous Immunoglobulin (IVIG) can help reduce&#xD;
      respiratory complications (respiratory failure and need for a ventilator) caused by&#xD;
      coronavirus disease 2019 (COVID-19). The principal investigator has successfully utilized&#xD;
      IVIG for patients infected with the influenza virus. The investigator wants to find out if&#xD;
      IVIG is equally effective in COVID-19 infection patients, and if IVIG will give the immune&#xD;
      system some help to clear the infection naturally.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an investigator initiated, open label, multicenter, two arm, randomized study to&#xD;
      compare the impact of adding IVIG to the Standard of Care (SOC) to the SOC without IVIG.&#xD;
      Randomization will be 1:1. The goal of this study is to identify whether or not IVIG can halt&#xD;
      the progression to respiratory failure requiring mechanical ventilation in subjects admitted&#xD;
      to the hospital with confirmed COVID-19. The addition of IVIG to the standard of care&#xD;
      treatment for these patients may be beneficial in abating acute lung injury in subjects with&#xD;
      SARSCoV-2 induced hypoxia that results in organ injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 28, 2020</start_date>
  <completion_date type="Actual">June 23, 2020</completion_date>
  <primary_completion_date type="Actual">June 23, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Subjects will be randomized into one of two groups: Standard of Care plus IVIG or Standard of Care.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mechanical Ventilation</measure>
    <time_frame>from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days</time_frame>
    <description>Number of subjects requiring mechanical ventilation due to respiratory failure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxygen Therapy</measure>
    <time_frame>from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days</time_frame>
    <description>Number of days requiring oxygen therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay</measure>
    <time_frame>from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 60 days</time_frame>
    <description>Number of days in hospital</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Sars-CoV2</condition>
  <arm_group>
    <arm_group_label>Group A (study drug+SOC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B (SOC)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of Care</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Octagam</intervention_name>
    <description>Standard of Care plus Octagam infusion for 3 days.</description>
    <arm_group_label>Group A (study drug+SOC)</arm_group_label>
    <other_name>IVIG</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed COVID-19 positive test result (including presumptive positive).&#xD;
&#xD;
          -  Hospitalization&#xD;
&#xD;
          -  Requiring ≥4 liters/min O2 nasal cannula to maintain oxygen saturation ≥ 92%, but not&#xD;
             mechanically ventilated&#xD;
&#xD;
          -  Age ≥18 years old.&#xD;
&#xD;
          -  Access to a phone in the hospital room or an electronic device that is capable of&#xD;
             receiving phone calls and/or video calls and/or e-mail.&#xD;
&#xD;
          -  Able to read/write/speak English or Spanish fluently.&#xD;
&#xD;
          -  Subjects must have the capacity to provide consent or an appropriate Legally&#xD;
             Authorized Representative (LAR) to provide informed consent.&#xD;
&#xD;
        provide informed consent, and provide authorization of use and disclosure of personal&#xD;
        health information.&#xD;
&#xD;
          -  Negative pregnancy test for women of childbearing potential.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe allergy to any IVIG product formulation&#xD;
&#xD;
          -  History of DVT, PE, thromboembolic stroke or other thrombotic events&#xD;
&#xD;
          -  Hypersensitivity to corn. Octagam® contains maltose which is a sugar derived from&#xD;
             corn.&#xD;
&#xD;
          -  Uncontrolled hypertension (SBP&gt;180 mm Hg or DBP&gt;120mmHg)&#xD;
&#xD;
          -  Active participant in another research treatment study&#xD;
&#xD;
          -  Mechanically ventilated patient&#xD;
&#xD;
          -  Code status is Do Not Resuscitate or Do Not Intubate&#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>George Sakoulas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sharp HealthCare</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sharp Grossmont Hospital</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sharp Memorial Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <results_first_submitted>June 10, 2021</results_first_submitted>
  <results_first_submitted_qc>June 23, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 25, 2021</results_first_posted>
  <last_update_submitted>June 23, 2021</last_update_submitted>
  <last_update_submitted_qc>June 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sharp HealthCare</investigator_affiliation>
    <investigator_full_name>George Sakoulas, MD</investigator_full_name>
    <investigator_title>Infectious Disease Specialist</investigator_title>
  </responsible_party>
  <keyword>Coronavirus</keyword>
  <keyword>IVIG</keyword>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>gamma-Globulins</mesh_term>
    <mesh_term>Immunoglobulins, Intravenous</mesh_term>
    <mesh_term>Rho(D) Immune Globulin</mesh_term>
  </intervention_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>May 19, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT04411667/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group A (Study Drug+SOC)</title>
          <description>Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.&#xD;
Octagam: Standard of Care plus Octagam infusion for 3 days.</description>
        </group>
        <group group_id="P2">
          <title>Group B (SOC)</title>
          <description>Standard of Care</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group A (Study Drug+SOC)</title>
          <description>Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.&#xD;
Octagam: Standard of Care plus Octagam infusion for 3 days.</description>
        </group>
        <group group_id="B2">
          <title>Group B (SOC)</title>
          <description>Standard of Care</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="16"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="33"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="54" lower_limit="27" upper_limit="69"/>
                    <measurement group_id="B2" value="54" lower_limit="19" upper_limit="80"/>
                    <measurement group_id="B3" value="54" lower_limit="19" upper_limit="80"/>
                  </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="B1" value="59" lower_limit="27" upper_limit="69"/>
                    <measurement group_id="B2" value="51" lower_limit="19" upper_limit="80"/>
                    <measurement group_id="B3" value="56" lower_limit="19" upper_limit="80"/>
                  </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="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </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="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.5" lower_limit="20.8" upper_limit="49.6"/>
                    <measurement group_id="B2" value="34.9" lower_limit="22.7" upper_limit="51.9"/>
                    <measurement group_id="B3" value="33.6" lower_limit="20.8" upper_limit="51.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidities</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Diabetes mellitus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chronic kidney disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coronary artery disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Congestive heart failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthma/chronic obstructive pulmonary disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Current smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Former smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immunocompromised</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidities Continued (HbA1c)</title>
          <units>% glycosylated hemoglobin</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.1" lower_limit="9" upper_limit="12.9"/>
                    <measurement group_id="B2" value="6.4" lower_limit="4.8" upper_limit="7.3"/>
                    <measurement group_id="B3" value="8.1" lower_limit="4.8" upper_limit="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Other Coronavirus Disease 2019 Therapies</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Remdesivir</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Convalescent plasma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucocorticoids</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mechanical Ventilation</title>
        <description>Number of subjects requiring mechanical ventilation due to respiratory failure</description>
        <time_frame>from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A (Study Drug+SOC)</title>
            <description>Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.&#xD;
Octagam: Standard of Care plus Octagam infusion for 3 days.</description>
          </group>
          <group group_id="O2">
            <title>Group B (SOC)</title>
            <description>Standard of Care</description>
          </group>
        </group_list>
        <measure>
          <title>Mechanical Ventilation</title>
          <description>Number of subjects requiring mechanical ventilation due to respiratory failure</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="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Oxygen Therapy</title>
        <description>Number of days requiring oxygen therapy</description>
        <time_frame>from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days</time_frame>
        <population>This data was not collected although it was originally intended to be an outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Group A (Study Drug+SOC)</title>
            <description>Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.&#xD;
Octagam: Standard of Care plus Octagam infusion for 3 days.</description>
          </group>
          <group group_id="O2">
            <title>Group B (SOC)</title>
            <description>Standard of Care</description>
          </group>
        </group_list>
        <measure>
          <title>Oxygen Therapy</title>
          <description>Number of days requiring oxygen therapy</description>
          <population>This data was not collected although it was originally intended to be an outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Stay</title>
        <description>Number of days in hospital</description>
        <time_frame>from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 60 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A (Study Drug+SOC)</title>
            <description>Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.&#xD;
Octagam: Standard of Care plus Octagam infusion for 3 days.</description>
          </group>
          <group group_id="O2">
            <title>Group B (SOC)</title>
            <description>Standard of Care</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Stay</title>
          <description>Number of days in hospital</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" lower_limit="6" upper_limit="29"/>
                    <measurement group_id="O2" value="17" lower_limit="4" upper_limit="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>from date of patient enrollment to date of patient discharge or date of death, whichever came first, assessed up to 45 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Group A (Study Drug+SOC)</title>
          <description>Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.&#xD;
Octagam: Standard of Care plus Octagam infusion for 3 days.</description>
        </group>
        <group group_id="E2">
          <title>Group B (SOC)</title>
          <description>Standard of Care</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="1" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Elevated D-Dimer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Elevated Liver Function Tests</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Thrombocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Hypoxic Respiratory Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </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>
    <limitations_and_caveats>Study limited to two hospitals in one US city. Resulted in a homogenous population of younger Hispanic/Latino patients.&#xD;
Study was not blinded.&#xD;
Methylprednisolone was used as a pre-medication for each dose of IVIG which may have confounded the results.&#xD;
Small sample size.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Matthew Geriak, PharmD / Research Pharmacist</name_or_title>
      <organization>Sharp HealthCare</organization>
      <phone>8589393717</phone>
      <email>matthew.geriak@sharp.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/NCT04411667
org study id: COVID-IVIG
secondary id: 2004902
nct id: NCT04411667
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this research is to see if Intravenous Immunoglobulin (IVIG) can help reduce
      respiratory complications (respiratory failure and need for a ventilator) caused by
      coronavirus disease 2019 (COVID-19). The principal investigator has successfully utilized
      IVIG for patients infected with the influenza virus. The investigator wants to find out if
      IVIG is equally effective in COVID-19 infection patients, and if IVIG will give the immune
      system some help to clear the infection naturally.
This is an investigator initiated, open label, multicenter, two arm, randomized study to
      compare the impact of adding IVIG to the Standard of Care (SOC) to the SOC without IVIG.
      Randomization will be 1:1. The goal of this study is to identify whether or not IVIG can halt
      the progression to respiratory failure requiring mechanical ventilation in subjects admitted
      to the hospital with confirmed COVID-19. The addition of IVIG to the standard of care
      treatment for these patients may be beneficial in abating acute lung injury in subjects with
      SARSCoV-2 induced hypoxia that results in organ injury.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will be randomized into one of two groups: Standard of Care plus IVIG or Standard of Care.
primary purpose: Treatment
masking: None (Open Label)
measure: Mechanical Ventilation
time frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
description: Number of subjects requiring mechanical ventilation due to respiratory failure
measure: Oxygen Therapy
time frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
description: Number of days requiring oxygen therapy
measure: Length of Stay
time frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 60 days
description: Number of days in hospital
arm group label: Group A (study drug+SOC)
arm group type: Experimental
description: Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.
arm group label: Group B (SOC)
arm group type: No Intervention
description: Standard of Care
intervention type: Drug
intervention name: Octagam
description: Standard of Care plus Octagam infusion for 3 days.
arm group label: Group A (study drug+SOC)
other name: IVIG
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: George Sakoulas, MD
role: Principal Investigator
affiliation: Sharp HealthCare
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Sharp HealthCare
investigator full name: George Sakoulas, MD
investigator title: Infectious Disease Specialist
mesh term: COVID-19
mesh term: gamma-Globulins
mesh term: Immunoglobulins, Intravenous
mesh term: Rho(D) Immune Globulin
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study limited to two hospitals in one US city. Resulted in a homogenous population of younger Hispanic/Latino patients.
Study was not blinded.
Methylprednisolone was used as a pre-medication for each dose of IVIG which may have confounded the results.
Small sample size.
point of contact: 