<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/NCT04432298</url>
  </required_header>
  <id_info>
    <org_study_id>FGCL-3019-098</org_study_id>
    <nct_id>NCT04432298</nct_id>
  </id_info>
  <brief_title>Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease</brief_title>
  <official_title>Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of the Efficacy and Safety of Intravenous Pamrevlumab, a Monoclonal Antibody Against Connective Tissue Growth Factor (CTGF), in Hospitalized Patients With Acute COVID-19 Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>FibroGen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>FibroGen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the efficacy and safety of intravenous (IV) infusions of pamrevlumab&#xD;
      when compared with placebo in participants who are hospitalized with acute COVID-19 disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blind, placebo-controlled, phase 2, proof-of-concept study to&#xD;
      evaluate the efficacy and safety of IV pamrevlumab, a monoclonal antibody, against&#xD;
      connective-tissue growth factor (CTGF), in participants hospitalized with acute COVID-19&#xD;
      disease.&#xD;
&#xD;
      All concomitant medications, including approved and non-approved treatments for COVID-19&#xD;
      (such as, hydroxychloroquine or interleukin 6 [IL-6] inhibitors), as well as supplemental&#xD;
      oxygenation needs, will be collected and recorded. In addition, the following will be&#xD;
      collected and recorded: documentation of Severe Acute Respiratory Syndrome coronavirus&#xD;
      (SARS-Cov-2) infection, documentation of any other infection(s) prior to or during&#xD;
      hospitalization, and whether or not aggressive care is withheld or withdrawn, including the&#xD;
      reason for withholding or withdrawal of care (such as a Do Not Resuscitate/Do Not Intubate&#xD;
      [DNR/DNI] order or a resource limitation).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated by Sponsor due to low enrollment.&#xD;
  </why_stopped>
  <start_date type="Actual">June 20, 2020</start_date>
  <completion_date type="Actual">March 22, 2021</completion_date>
  <primary_completion_date type="Actual">March 22, 2021</primary_completion_date>
  <phase>Phase 2</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>Proof-of-concept</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) at Day 28</measure>
    <time_frame>Day 28</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Alive, Discharged Home, and Not on Supplemental Oxygen at Day 28</measure>
    <time_frame>Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Alive Who Never Received Mechanical Ventilation and/or ECMO at Day 14</measure>
    <time_frame>Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Recovery as Based on a Modified 8-Point Ordinal Scale</measure>
    <time_frame>Day 28</time_frame>
    <description>Recovery was defined as the first day on which the participant satisfied 1 of the following 3 categories from the 8-point ordinal scale: (1) hospitalized, not requiring supplemental oxygen; (2) Not hospitalized (discharged), but with limitation on activities and/or requiring home supplemental oxygen; (3) Not hospitalized (discharged), with no limitations on activities and not requiring supplemental oxygen).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days in Intensive Care Unit/Critical Care Unit (ICU/CCU) (Either on or Off Mechanical Ventilation and/or ECMO)</measure>
    <time_frame>up to Day 28</time_frame>
    <description>Days in ICU/CCU was calculated as Event end date/time - Event start data/time + 1. Participants who died in ICU/CCU before Day 28, days in ICU/CCU is calculated up to the death date. Days in ICU/CCU were censored after Day 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days on Mechanical Ventilation and/or ECMO</measure>
    <time_frame>up to Day 28</time_frame>
    <description>Days on Mechanical Ventilation and/or ECMO was calculated as Event end date/time - Event start data/time. Participants who died on MV/ECMO before Day 28, days on MV/ECMO is calculated up to the death date. Days on MV/ECMO are censored after Day 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Mechanical Ventilation/ECMO or All-cause Mortality</measure>
    <time_frame>up to Day 28</time_frame>
    <description>Time (number of days) from randomization to mechanical ventilation/ECMO or all-cause mortality by Day 28. Participants without the event are not included in the calculation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With All-cause Mortality</measure>
    <time_frame>up to Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Pressure of Arterial Oxygen to Fractional Inspired Oxygen Concentration (PaO2/FiO2) Ratio, Both as Categorical and Continuous Variables</measure>
    <time_frame>up to Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Death From Any Cause</measure>
    <time_frame>up to Day 28</time_frame>
    <description>Time (number of days) from randomization to death from any cause by Day 28. Participants without the event are not included in the calculation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Resting Peripheral Oxygen Saturation (SpO2) Adjusted by FiO2</measure>
    <time_frame>up to Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in (Non-invasive) Oxygen Supplementation Requirements</measure>
    <time_frame>up to Day 28</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Pamrevlumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pamrevlumab</intervention_name>
    <description>Sterile liquid for injection</description>
    <arm_group_label>Pamrevlumab</arm_group_label>
    <other_name>FG-3019</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Sterile liquid for injection</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Confirmed SARS-CoV-2 infection&#xD;
&#xD;
          2. Respiratory compromise requiring hospitalization for COVID-19 disease as evidenced by&#xD;
             at least one (or more) of the following criteria:&#xD;
&#xD;
               -  Interstitial pneumonia on chest x-ray or high-resolution computed tomography&#xD;
                  (findings of consolidation or ground glass opacities), OR&#xD;
&#xD;
               -  Peripheral capillary oxygen saturation &lt; 94% on room air, OR&#xD;
&#xD;
               -  Requiring non-invasive supplemental oxygen (such as, nasal cannula, face mask) to&#xD;
                  maintain SpO2&#xD;
&#xD;
          3. Not requiring mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO)&#xD;
             use at time of randomization&#xD;
&#xD;
          4. Not participating in another clinical trial for the treatment of COVID-19 disease&#xD;
             through Day 28&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female participants who are pregnant or nursing&#xD;
&#xD;
          2. Participation in a clinical trial with another investigational drug for COVID-19&#xD;
             disease&#xD;
&#xD;
          3. Anticipated discharge from the hospital or transfer to another hospital or long-term&#xD;
             care facility which is not a study site within 72 hours of randomization&#xD;
&#xD;
          4. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine&#xD;
             monoclonal antibodies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Center</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <results_first_submitted>April 27, 2022</results_first_submitted>
  <results_first_submitted_qc>July 14, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 18, 2022</results_first_posted>
  <last_update_submitted>July 14, 2022</last_update_submitted>
  <last_update_submitted_qc>July 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Severe Acute Respiratory Syndrome coronavirus</keyword>
  <keyword>SARS-COV-2 infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 12, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT04432298/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 20, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT04432298/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pamrevlumab</title>
          <description>Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Intent-to-Treat (ITT) Population</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other than specified</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>ITT population: All randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Pamrevlumab</title>
          <description>Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</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="11"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="22"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61" spread="10"/>
                    <measurement group_id="B2" value="61" spread="14"/>
                    <measurement group_id="B3" value="61" spread="12"/>
                  </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="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </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="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <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_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</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>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <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_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) at Day 28</title>
        <time_frame>Day 28</time_frame>
        <population>ITT Population: All randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Pamrevlumab</title>
            <description>Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) at Day 28</title>
          <population>ITT Population: All randomized participants.</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="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Alive, Discharged Home, and Not on Supplemental Oxygen at Day 28</title>
        <time_frame>Day 28</time_frame>
        <population>ITT Population: All randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Pamrevlumab</title>
            <description>Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Alive, Discharged Home, and Not on Supplemental Oxygen at Day 28</title>
          <population>ITT Population: All randomized participants.</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="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Alive Who Never Received Mechanical Ventilation and/or ECMO at Day 14</title>
        <time_frame>Day 14</time_frame>
        <population>ITT Population: All randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Pamrevlumab</title>
            <description>Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Alive Who Never Received Mechanical Ventilation and/or ECMO at Day 14</title>
          <population>ITT Population: All randomized participants.</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="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Recovery as Based on a Modified 8-Point Ordinal Scale</title>
        <description>Recovery was defined as the first day on which the participant satisfied 1 of the following 3 categories from the 8-point ordinal scale: (1) hospitalized, not requiring supplemental oxygen; (2) Not hospitalized (discharged), but with limitation on activities and/or requiring home supplemental oxygen; (3) Not hospitalized (discharged), with no limitations on activities and not requiring supplemental oxygen).</description>
        <time_frame>Day 28</time_frame>
        <population>ITT Population: All randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Pamrevlumab</title>
            <description>Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Recovery as Based on a Modified 8-Point Ordinal Scale</title>
          <description>Recovery was defined as the first day on which the participant satisfied 1 of the following 3 categories from the 8-point ordinal scale: (1) hospitalized, not requiring supplemental oxygen; (2) Not hospitalized (discharged), but with limitation on activities and/or requiring home supplemental oxygen; (3) Not hospitalized (discharged), with no limitations on activities and not requiring supplemental oxygen).</description>
          <population>ITT Population: All randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" spread="10"/>
                    <measurement group_id="O2" value="11" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Days in Intensive Care Unit/Critical Care Unit (ICU/CCU) (Either on or Off Mechanical Ventilation and/or ECMO)</title>
        <description>Days in ICU/CCU was calculated as Event end date/time - Event start data/time + 1. Participants who died in ICU/CCU before Day 28, days in ICU/CCU is calculated up to the death date. Days in ICU/CCU were censored after Day 28.</description>
        <time_frame>up to Day 28</time_frame>
        <population>ITT Population: All randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Pamrevlumab</title>
            <description>Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Days in Intensive Care Unit/Critical Care Unit (ICU/CCU) (Either on or Off Mechanical Ventilation and/or ECMO)</title>
          <description>Days in ICU/CCU was calculated as Event end date/time - Event start data/time + 1. Participants who died in ICU/CCU before Day 28, days in ICU/CCU is calculated up to the death date. Days in ICU/CCU were censored after Day 28.</description>
          <population>ITT Population: All randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" spread="14"/>
                    <measurement group_id="O2" value="12" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Days on Mechanical Ventilation and/or ECMO</title>
        <description>Days on Mechanical Ventilation and/or ECMO was calculated as Event end date/time - Event start data/time. Participants who died on MV/ECMO before Day 28, days on MV/ECMO is calculated up to the death date. Days on MV/ECMO are censored after Day 28.</description>
        <time_frame>up to Day 28</time_frame>
        <population>ITT Population: All randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Pamrevlumab</title>
            <description>Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Days on Mechanical Ventilation and/or ECMO</title>
          <description>Days on Mechanical Ventilation and/or ECMO was calculated as Event end date/time - Event start data/time. Participants who died on MV/ECMO before Day 28, days on MV/ECMO is calculated up to the death date. Days on MV/ECMO are censored after Day 28.</description>
          <population>ITT Population: All randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.5" spread="0.0"/>
                    <measurement group_id="O2" value="8.7" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Mechanical Ventilation/ECMO or All-cause Mortality</title>
        <description>Time (number of days) from randomization to mechanical ventilation/ECMO or all-cause mortality by Day 28. Participants without the event are not included in the calculation.</description>
        <time_frame>up to Day 28</time_frame>
        <population>ITT Population: All randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Pamrevlumab</title>
            <description>Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Mechanical Ventilation/ECMO or All-cause Mortality</title>
          <description>Time (number of days) from randomization to mechanical ventilation/ECMO or all-cause mortality by Day 28. Participants without the event are not included in the calculation.</description>
          <population>ITT Population: All randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" spread="11"/>
                    <measurement group_id="O2" value="14" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With All-cause Mortality</title>
        <time_frame>up to Day 28</time_frame>
        <population>ITT Population: All randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Pamrevlumab</title>
            <description>Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With All-cause Mortality</title>
          <population>ITT Population: All randomized participants.</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="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Pressure of Arterial Oxygen to Fractional Inspired Oxygen Concentration (PaO2/FiO2) Ratio, Both as Categorical and Continuous Variables</title>
        <time_frame>up to Day 28</time_frame>
        <population>Due to early termination of the study, data was not collected for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Pamrevlumab</title>
            <description>Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Pressure of Arterial Oxygen to Fractional Inspired Oxygen Concentration (PaO2/FiO2) Ratio, Both as Categorical and Continuous Variables</title>
          <population>Due to early termination of the study, data was not collected for the assessment.</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>Time to Death From Any Cause</title>
        <description>Time (number of days) from randomization to death from any cause by Day 28. Participants without the event are not included in the calculation.</description>
        <time_frame>up to Day 28</time_frame>
        <population>ITT Population: All randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Pamrevlumab</title>
            <description>Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Death From Any Cause</title>
          <description>Time (number of days) from randomization to death from any cause by Day 28. Participants without the event are not included in the calculation.</description>
          <population>ITT Population: All randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17" spread="15"/>
                    <measurement group_id="O2" value="13" spread="NA">Not evaluable due to small number of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Resting Peripheral Oxygen Saturation (SpO2) Adjusted by FiO2</title>
        <time_frame>up to Day 28</time_frame>
        <population>Due to early termination of the study, data was not collected for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Pamrevlumab</title>
            <description>Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Resting Peripheral Oxygen Saturation (SpO2) Adjusted by FiO2</title>
          <population>Due to early termination of the study, data was not collected for the assessment.</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>Change in (Non-invasive) Oxygen Supplementation Requirements</title>
        <time_frame>up to Day 28</time_frame>
        <population>Due to early termination of the study, data was not collected for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Pamrevlumab</title>
            <description>Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in (Non-invasive) Oxygen Supplementation Requirements</title>
          <population>Due to early termination of the study, data was not collected for the assessment.</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_list>

    <reported_events>
      <time_frame>Baseline up to Day 28</time_frame>
      <desc>Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.</desc>
      <group_list>
        <group group_id="E1">
          <title>Pamrevlumab</title>
          <description>Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.0</default_vocab>
        <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="3" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Peripheral artery thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 24.0</default_vocab>
        <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="4" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Polycythaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pneumomediastinum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </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>The multisite consortium can publish any time after the data is collected and analyzed by FibroGen. The investigator can only publish after the multisite consortium publishes (or tries to publish and fails). FibroGen has 60 days to review a publication and can extend the embargo up to an additional 120 days (or 180 total).</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Due to early termination of this study, formal analyses of the primary and secondary endpoints are not presented because the study's sample size is substantially underpowered for meaningful interpretation.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Clinical Trial Information Desk</name_or_title>
      <organization>FibroGen, Inc.</organization>
      <phone>415-978-1346</phone>
      <email>jcharpentier@fibrogen.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/NCT04432298
org study id: FGCL-3019-098
nct id: NCT04432298
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study evaluates the efficacy and safety of intravenous (IV) infusions of pamrevlumab
      when compared with placebo in participants who are hospitalized with acute COVID-19 disease.
This is a randomized, double-blind, placebo-controlled, phase 2, proof-of-concept study to
      evaluate the efficacy and safety of IV pamrevlumab, a monoclonal antibody, against
      connective-tissue growth factor (CTGF), in participants hospitalized with acute COVID-19
      disease.

      All concomitant medications, including approved and non-approved treatments for COVID-19
      (such as, hydroxychloroquine or interleukin 6 [IL-6] inhibitors), as well as supplemental
      oxygenation needs, will be collected and recorded. In addition, the following will be
      collected and recorded: documentation of Severe Acute Respiratory Syndrome coronavirus
      (SARS-Cov-2) infection, documentation of any other infection(s) prior to or during
      hospitalization, and whether or not aggressive care is withheld or withdrawn, including the
      reason for withholding or withdrawal of care (such as a Do Not Resuscitate/Do Not Intubate
      [DNR/DNI] order or a resource limitation).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Proof-of-concept
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) at Day 28
time frame: Day 28
measure: Number of Participants Alive, Discharged Home, and Not on Supplemental Oxygen at Day 28
time frame: Day 28
measure: Number of Participants Alive Who Never Received Mechanical Ventilation and/or ECMO at Day 14
time frame: Day 14
measure: Time to Recovery as Based on a Modified 8-Point Ordinal Scale
time frame: Day 28
description: Recovery was defined as the first day on which the participant satisfied 1 of the following 3 categories from the 8-point ordinal scale: (1) hospitalized, not requiring supplemental oxygen; (2) Not hospitalized (discharged), but with limitation on activities and/or requiring home supplemental oxygen; (3) Not hospitalized (discharged), with no limitations on activities and not requiring supplemental oxygen).
measure: Days in Intensive Care Unit/Critical Care Unit (ICU/CCU) (Either on or Off Mechanical Ventilation and/or ECMO)
time frame: up to Day 28
description: Days in ICU/CCU was calculated as Event end date/time - Event start data/time + 1. Participants who died in ICU/CCU before Day 28, days in ICU/CCU is calculated up to the death date. Days in ICU/CCU were censored after Day 28.
measure: Days on Mechanical Ventilation and/or ECMO
time frame: up to Day 28
description: Days on Mechanical Ventilation and/or ECMO was calculated as Event end date/time - Event start data/time. Participants who died on MV/ECMO before Day 28, days on MV/ECMO is calculated up to the death date. Days on MV/ECMO are censored after Day 28.
measure: Time to Mechanical Ventilation/ECMO or All-cause Mortality
time frame: up to Day 28
description: Time (number of days) from randomization to mechanical ventilation/ECMO or all-cause mortality by Day 28. Participants without the event are not included in the calculation.
measure: Number of Participants With All-cause Mortality
time frame: up to Day 28
measure: Changes in Pressure of Arterial Oxygen to Fractional Inspired Oxygen Concentration (PaO2/FiO2) Ratio, Both as Categorical and Continuous Variables
time frame: up to Day 28
measure: Time to Death From Any Cause
time frame: up to Day 28
description: Time (number of days) from randomization to death from any cause by Day 28. Participants without the event are not included in the calculation.
measure: Change in Resting Peripheral Oxygen Saturation (SpO2) Adjusted by FiO2
time frame: up to Day 28
measure: Change in (Non-invasive) Oxygen Supplementation Requirements
time frame: up to Day 28
arm group label: Pamrevlumab
arm group type: Experimental
description: Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
arm group label: Placebo
arm group type: Experimental
description: Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
intervention type: Drug
intervention name: Pamrevlumab
description: Sterile liquid for injection
arm group label: Pamrevlumab
other name: FG-3019
intervention type: Drug
intervention name: Placebo
description: Sterile liquid for injection
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to early termination of this study, formal analyses of the primary and secondary endpoints are not presented because the study's sample size is substantially underpowered for meaningful interpretation.
point of contact: 