<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/NCT04411680</url>
  </required_header>
  <id_info>
    <org_study_id>PTX-001-002</org_study_id>
    <nct_id>NCT04411680</nct_id>
  </id_info>
  <brief_title>Study of Sargramostim in Patients With COVID-19</brief_title>
  <acronym>iLeukPulm</acronym>
  <official_title>A Phase 2 Trial Evaluating Sargramostim in Patients With COVID-19 Associated Acute Hypoxemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Partner Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Partner Therapeutics, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to find out if a drug (sargramostim) also known as Leukine®&#xD;
      could help patient recover faster from COVID-19. Sargramostim may help the lungs recover from&#xD;
      the effects of COVID-19, and this research study will help to find this out.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This Phase 2 study is designed as a proof of concept study and will randomize 2:1&#xD;
      approximately 120 patients with COVID-19 associated acute hypoxemia: of which 80 patients&#xD;
      will receive sargramostim plus standard of care, and 40 patients who will receive standard of&#xD;
      care alone. The aim of the study is to determine if inhaled sargramostim, as an adjunct to&#xD;
      institutional standard of care, improves clinical outcomes in patients with&#xD;
      COVID-19-associated acute hypoxemia. All patients on the sargramostim arm will be treated&#xD;
      with 125 mcg inhaled sargramostim twice daily for 5 days, in addition to institutional&#xD;
      standard of care. If required, upon progression to an invasive mechanical ventilator,&#xD;
      administration of sargramostim may be delivered by intravenous infusion to complete a total&#xD;
      of 5 days (including days delivered via inhalation).&#xD;
&#xD;
      GM-CSF is a critical cytokine for healthy pulmonary function and is necessary for the&#xD;
      maturation and maintenance of alveolar macrophages. Preclinical studies have shown GM-CSF&#xD;
      confers resistance to influenza by enhancing innate immune mechanisms that depend on alveolar&#xD;
      macrophages for their health and normal functioning. Clinical studies of sargramostim in&#xD;
      patients with severe sepsis and respiratory dysfunction or acute respiratory distress&#xD;
      syndrome have shown improvements in oxygenation and lung compliance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 18, 2020</start_date>
  <completion_date type="Actual">May 19, 2021</completion_date>
  <primary_completion_date type="Actual">March 2, 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>This Phase 2, randomized, open-label study will enroll approximately 120 patients with COVID-19 associated acute hypoxemia. It is a randomized 2:1 study to evaluate sargramostim treatment plus institutional standard of care compared to institutional standard of care alone.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Oxygenation Parameter of P(A-a)O2 Gradient by Day 6</measure>
    <time_frame>1-6 days</time_frame>
    <description>The P(A-a)O2 gradient is a measure of how well the oxygen moves from the lungs into the bloodstream. Patients with a high gradient have less oxygen in the bloodstream.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Patients Who Have Been Intubated by Day 14</measure>
    <time_frame>1-14 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Ordinal Scale</measure>
    <time_frame>1-28 days</time_frame>
    <description>The ordinal scale was used, where 0 is not hospitalized, no clinical or virological evidence of infection, and 8 is death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All Cause 28-day Mortality</measure>
    <time_frame>1-28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Treatment-related Adverse Events</measure>
    <time_frame>1-58 days</time_frame>
    <description>Number of patients with side effects related to treatment with sargramostim. Patients on the control arm did not receive sargramostim.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival Time of Patients</measure>
    <time_frame>Day 1-90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Causes of Death</measure>
    <time_frame>Day 1-90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in P/F Ratio</measure>
    <time_frame>From Day 1 up to Day 6</time_frame>
    <description>The P/F ratio is a simple way to assess severity of low blood oxygen. It's the ratio of PaO2 (arterial oxygen partial pressure obtained from an arterial blood gas) to FiO2 (fraction of inspired oxygen expressed as a decimal). A normal arterial blood is gas 80 to 100 mm Hg. Normal room air has 21% or 0.21 oxygen. So a &quot;normal&quot; P/F ratio is about 380-475. A high P/F ratio means more oxygen in the bloodstream and a low P/F ratio means less oxygen in the bloodstream.&#xD;
This outcome measure compares the improvement (increase) in P/F ratio between treatment arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Wtih Nosocomial Infections</measure>
    <time_frame>Day 1-90</time_frame>
    <description>Nosocomial infections also referred to as healthcare-associated infections (HAI), are infection(s) acquired during the process of receiving health care that was not present during the time of admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Requiring Invasive Mechanical Ventilation</measure>
    <time_frame>Day 1-90</time_frame>
    <description>The is the number of patients that needed to be placed on a ventilator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Invasive, Non-invasive and Supplemental Oxygen</measure>
    <time_frame>Day 1-90</time_frame>
    <description>This endpoint includes duration of any/all types of respiratory support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Hospitalization</measure>
    <time_frame>Day 1-90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Normalization of White Blood Cells and Lymphocytes</measure>
    <time_frame>Day 1-90</time_frame>
    <description>Normalization of WBC and lymphocyte count is defined as whether WBC and lymphocyte count results are normal or below normal or above normal ranges at available visits.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">123</enrollment>
  <condition>COVID-19</condition>
  <condition>SARS-CoV-2</condition>
  <arm_group>
    <arm_group_label>Sargramostim Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard of care for COVID-19</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sargramostim</intervention_name>
    <description>Sargramostim is a glycosylated, yeast-derived recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.</description>
    <arm_group_label>Sargramostim Arm</arm_group_label>
    <other_name>Leukine</other_name>
    <other_name>GM-CSF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <description>Standard of care for COVID-19</description>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_label>Sargramostim Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged ≥ 18 years&#xD;
&#xD;
          -  Patients (or legally authorized decision maker) must provide informed consent&#xD;
&#xD;
          -  Test positive for SARS-CoV-2 virus by PCR&#xD;
&#xD;
          -  Admitted to hospital&#xD;
&#xD;
          -  Presence of acute hypoxemia defined as (either or both)&#xD;
&#xD;
               -  saturation below 93% on ≥ 2 L/min oxygen supplementation&#xD;
&#xD;
               -  PaO2/FiO2 below 350&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients requiring invasive (mechanical ventilation) or non-invasive (CPAP, BiPAP for&#xD;
             hypoxemia) ventilation or ECMO (Note: oxygen supplementation using high flow oxygen&#xD;
             systems or low flow oxygen systems would not exclude patients from this study)&#xD;
&#xD;
          -  Intractable metabolic acidosis&#xD;
&#xD;
          -  Cardiogenic pulmonary edema&#xD;
&#xD;
          -  Hypotension requiring use of vasopressors&#xD;
&#xD;
          -  Hyperferritinemia (serum ferritin ≥2,000 mcg/L)&#xD;
&#xD;
          -  White blood cell count &gt; 50,000/mm3&#xD;
&#xD;
          -  Participation in another interventional clinical trial for COVID-19 therapy&#xD;
&#xD;
          -  Highly immunosuppressive therapy or anti-cancer combination chemotherapy within 24&#xD;
             hours prior to first dose of sargramostim&#xD;
&#xD;
          -  Known or suspected intolerance or hypersensitivity to sargramostim, or any component&#xD;
             of the product&#xD;
&#xD;
          -  Previous experience of severe and unexplained side effects during aerosol delivery of&#xD;
             any kind of medical product&#xD;
&#xD;
          -  Presence of any preexisting illness that, in the opinion of the Investigator, would&#xD;
             place the patient at an unreasonably increased risk through participation in this&#xD;
             study&#xD;
&#xD;
          -  Pregnant or breastfeeding females&#xD;
&#xD;
          -  Severe or uncontrolled pulmonary comorbid conditions, including systemic steroid&#xD;
             dependent asthma, systemic steroid dependent COPD, oxygen dependent COPD, lung&#xD;
             transplant, known interstitial lung disease, or cystic fibrosis&#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>Medical Information</last_name>
    <role>Study Director</role>
    <affiliation>Partner Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Jude Medical Center</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph Hospital of Orange</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Pacific Medical Center - Van Ness Campus</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TidalHealth Peninsula Regional, Inc</name>
      <address>
        <city>Salisbury</city>
        <state>Maryland</state>
        <zip>21801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri Health Care</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Plains Health</name>
      <address>
        <city>North Platte</city>
        <state>Nebraska</state>
        <zip>69101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Richmond University Medical Center</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10310</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brody School of Medicine at East Carolina University</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Toledo Medical Center</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hermann Hospital Affiliated with the University of Texas Health Science Center at Houston, McGovern Medical School</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Health</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Paine R, Chasse R, Halstead ES, Nfonoyim J, Park DJ, Byun T, Patel B, Molina-Pallete G, Harris ES, Garner F, Simms L, Ahuja S, McManus JL, Roychowdhury DF. Inhaled Sargramostim (Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor) for COVID-19-Associated Acute Hypoxemia: Results of the Phase 2, Randomized, Open-Label Trial (iLeukPulm). Mil Med. 2022 Dec 2;188(7-8):e2629-38. doi: 10.1093/milmed/usac362. Online ahead of print.</citation>
    <PMID>36458916</PMID>
  </results_reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <results_first_submitted>February 7, 2022</results_first_submitted>
  <results_first_submitted_qc>February 16, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 18, 2022</results_first_posted>
  <last_update_submitted>August 7, 2023</last_update_submitted>
  <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>sargramostim</keyword>
  <keyword>Leukine</keyword>
  <keyword>rhu-GM-CSF</keyword>
  <keyword>acute hypoxemia</keyword>
  <keyword>iLeukPulm</keyword>
  <keyword>SARS-CoV-2</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>Sargramostim</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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>December 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT04411680/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>March 17, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT04411680/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>One participant was randomized to the sargramostim arm and then withdrew consent prior to treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Sargramostim Arm</title>
          <description>Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19&#xD;
Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.&#xD;
Standard of care: Standard of care for COVID-19</description>
        </group>
        <group group_id="P2">
          <title>Control Arm</title>
          <description>Standard of care for COVID-19&#xD;
Standard of care: Standard of care for COVID-19</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discharged from hospital</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missed 1 or more doses</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Transferred to another hospital</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow up Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <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>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>One patient was randomized to the Sargramostim Arm, but was not treated.</population>
      <group_list>
        <group group_id="B1">
          <title>Sargramostim Arm</title>
          <description>Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19&#xD;
Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.&#xD;
Standard of care: Standard of care for COVID-19</description>
        </group>
        <group group_id="B2">
          <title>Control Arm</title>
          <description>Standard of care for COVID-19&#xD;
Standard of care: Standard of care for COVID-19</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="78"/>
            <count group_id="B2" value="44"/>
            <count group_id="B3" value="122"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="78"/>
                    <count group_id="B2" value="44"/>
                    <count group_id="B3" value="122"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="78"/>
                    <count group_id="B2" value="44"/>
                    <count group_id="B3" value="122"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.7" spread="13.00"/>
                    <measurement group_id="B2" value="58.2" spread="10.61"/>
                    <measurement group_id="B3" value="60.4" spread="12.26"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="78"/>
                    <count group_id="B2" value="44"/>
                    <count group_id="B3" value="122"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="61"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="78"/>
                    <count group_id="B2" value="44"/>
                    <count group_id="B3" value="122"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="78"/>
                    <count group_id="B2" value="44"/>
                    <count group_id="B3" value="122"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <population>Data to calculate BMI is missing for 5 patients in sargramostim arm and 1 patient in control arm.</population>
          <units>kilograms/meter squared</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="43"/>
                    <count group_id="B3" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.86" spread="8.988"/>
                    <measurement group_id="B2" value="35.44" spread="9.647"/>
                    <measurement group_id="B3" value="35.07" spread="9.200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Oxygenation Parameter of P(A-a)O2 Gradient by Day 6</title>
        <description>The P(A-a)O2 gradient is a measure of how well the oxygen moves from the lungs into the bloodstream. Patients with a high gradient have less oxygen in the bloodstream.</description>
        <time_frame>1-6 days</time_frame>
        <population>Patients analyzed if they had both a baseline and at least 1 post-baseline measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Sargramostim Arm</title>
            <description>Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19&#xD;
Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Standard of care for COVID-19&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Oxygenation Parameter of P(A-a)O2 Gradient by Day 6</title>
          <description>The P(A-a)O2 gradient is a measure of how well the oxygen moves from the lungs into the bloodstream. Patients with a high gradient have less oxygen in the bloodstream.</description>
          <population>Patients analyzed if they had both a baseline and at least 1 post-baseline measurement.</population>
          <units>millimeters of mercury (mmHg)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-102.3" spread="19.44"/>
                    <measurement group_id="O2" value="-30.5" spread="26.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients Who Have Been Intubated by Day 14</title>
        <time_frame>1-14 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sargramostim Arm</title>
            <description>Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19&#xD;
Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Standard of care for COVID-19&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Who Have Been Intubated by Day 14</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Ordinal Scale</title>
        <description>The ordinal scale was used, where 0 is not hospitalized, no clinical or virological evidence of infection, and 8 is death.</description>
        <time_frame>1-28 days</time_frame>
        <population>Only 86 patients had follow up data at Day 28</population>
        <group_list>
          <group group_id="O1">
            <title>Sargramostim Arm</title>
            <description>Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19&#xD;
Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Standard of care for COVID-19&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Ordinal Scale</title>
          <description>The ordinal scale was used, where 0 is not hospitalized, no clinical or virological evidence of infection, and 8 is death.</description>
          <population>Only 86 patients had follow up data at Day 28</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.6" spread="1.49"/>
                    <measurement group_id="O2" value="-2.5" spread="1.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All Cause 28-day Mortality</title>
        <time_frame>1-28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sargramostim Arm</title>
            <description>Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19&#xD;
Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Standard of care for COVID-19&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
        </group_list>
        <measure>
          <title>All Cause 28-day Mortality</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Treatment-related Adverse Events</title>
        <description>Number of patients with side effects related to treatment with sargramostim. Patients on the control arm did not receive sargramostim.</description>
        <time_frame>1-58 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sargramostim Arm</title>
            <description>Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19&#xD;
Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Standard of care for COVID-19&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Treatment-related Adverse Events</title>
          <description>Number of patients with side effects related to treatment with sargramostim. Patients on the control arm did not receive sargramostim.</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="78"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Survival Time of Patients</title>
        <time_frame>Day 1-90</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sargramostim Arm</title>
            <description>Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19&#xD;
Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Standard of care for COVID-19&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
        </group_list>
        <measure>
          <title>Survival Time of Patients</title>
          <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="78"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.0" spread="27.05"/>
                    <measurement group_id="O2" value="72.6" spread="28.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Causes of Death</title>
        <time_frame>Day 1-90</time_frame>
        <population>Patients alive at Day 90 were not analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Sargramostim Arm</title>
            <description>Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19&#xD;
Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Standard of care for COVID-19&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
        </group_list>
        <measure>
          <title>Causes of Death</title>
          <population>Patients alive at Day 90 were not analyzed</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="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Acute respiratory distress syndrome</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Respiratory failure</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cardiorespiratory arrest</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Septic shock</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in P/F Ratio</title>
        <description>The P/F ratio is a simple way to assess severity of low blood oxygen. It's the ratio of PaO2 (arterial oxygen partial pressure obtained from an arterial blood gas) to FiO2 (fraction of inspired oxygen expressed as a decimal). A normal arterial blood is gas 80 to 100 mm Hg. Normal room air has 21% or 0.21 oxygen. So a &quot;normal&quot; P/F ratio is about 380-475. A high P/F ratio means more oxygen in the bloodstream and a low P/F ratio means less oxygen in the bloodstream.&#xD;
This outcome measure compares the improvement (increase) in P/F ratio between treatment arms.</description>
        <time_frame>From Day 1 up to Day 6</time_frame>
        <population>Patients were analyzed if they had both a baseline and at least 1 post-baseline measurement of P/F ratio.</population>
        <group_list>
          <group group_id="O1">
            <title>Sargramostim Arm</title>
            <description>Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19&#xD;
Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Standard of care for COVID-19&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in P/F Ratio</title>
          <description>The P/F ratio is a simple way to assess severity of low blood oxygen. It's the ratio of PaO2 (arterial oxygen partial pressure obtained from an arterial blood gas) to FiO2 (fraction of inspired oxygen expressed as a decimal). A normal arterial blood is gas 80 to 100 mm Hg. Normal room air has 21% or 0.21 oxygen. So a &quot;normal&quot; P/F ratio is about 380-475. A high P/F ratio means more oxygen in the bloodstream and a low P/F ratio means less oxygen in the bloodstream.&#xD;
This outcome measure compares the improvement (increase) in P/F ratio between treatment arms.</description>
          <population>Patients were analyzed if they had both a baseline and at least 1 post-baseline measurement of P/F ratio.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.70" spread="97.964"/>
                    <measurement group_id="O2" value="47.24" spread="99.942"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Wtih Nosocomial Infections</title>
        <description>Nosocomial infections also referred to as healthcare-associated infections (HAI), are infection(s) acquired during the process of receiving health care that was not present during the time of admission.</description>
        <time_frame>Day 1-90</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sargramostim Arm</title>
            <description>Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19&#xD;
Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Standard of care for COVID-19&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Wtih Nosocomial Infections</title>
          <description>Nosocomial infections also referred to as healthcare-associated infections (HAI), are infection(s) acquired during the process of receiving health care that was not present during the time of admission.</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="78"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Requiring Invasive Mechanical Ventilation</title>
        <description>The is the number of patients that needed to be placed on a ventilator.</description>
        <time_frame>Day 1-90</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sargramostim Arm</title>
            <description>Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19&#xD;
Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Standard of care for COVID-19&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Requiring Invasive Mechanical Ventilation</title>
          <description>The is the number of patients that needed to be placed on a ventilator.</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="78"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Invasive, Non-invasive and Supplemental Oxygen</title>
        <description>This endpoint includes duration of any/all types of respiratory support</description>
        <time_frame>Day 1-90</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sargramostim Arm</title>
            <description>Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19&#xD;
Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Standard of care for COVID-19&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Invasive, Non-invasive and Supplemental Oxygen</title>
          <description>This endpoint includes duration of any/all types of respiratory support</description>
          <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="78"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.9" spread="35.64"/>
                    <measurement group_id="O2" value="32.8" spread="34.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Hospitalization</title>
        <time_frame>Day 1-90</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sargramostim Arm</title>
            <description>Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19&#xD;
Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Standard of care for COVID-19&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Hospitalization</title>
          <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="78"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1" spread="9.39"/>
                    <measurement group_id="O2" value="11.8" spread="8.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Normalization of White Blood Cells and Lymphocytes</title>
        <description>Normalization of WBC and lymphocyte count is defined as whether WBC and lymphocyte count results are normal or below normal or above normal ranges at available visits.</description>
        <time_frame>Day 1-90</time_frame>
        <population>Of 78 and 44 participants in the Sargramostim and Control Arms, respectively, only 28 (35.8%) and 17 (38.6%) had both baseline and post-baseline values available for evaluation at the Day 6 timepoint of interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Sargramostim Arm</title>
            <description>Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19&#xD;
Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Standard of care for COVID-19&#xD;
Standard of care: Standard of care for COVID-19</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Normalization of White Blood Cells and Lymphocytes</title>
          <description>Normalization of WBC and lymphocyte count is defined as whether WBC and lymphocyte count results are normal or below normal or above normal ranges at available visits.</description>
          <population>Of 78 and 44 participants in the Sargramostim and Control Arms, respectively, only 28 (35.8%) and 17 (38.6%) had both baseline and post-baseline values available for evaluation at the Day 6 timepoint of interest.</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="28"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Insufficient number of participants with events</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Insufficient number of participants with events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Sargramostim Arm</title>
          <description>Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19&#xD;
Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.&#xD;
Standard of care: Standard of care for COVID-19</description>
        </group>
        <group group_id="E2">
          <title>Control Arm</title>
          <description>Standard of care for COVID-19&#xD;
Standard of care: Standard of care for COVID-19</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA v.23.1</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="11" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <description>Abnormal heartbeat</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <description>Abnormal heartbeat</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <description>Skin infection</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <description>Shock due to infection</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>False positive investigation result</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <description>Too much potassium in the blood stream</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Alcohol withdrawal syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
              </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="78"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Anuria</sub_title>
                <description>Absence of urination</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
              </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="4" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <description>Emphysema</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <description>Not enough oxygen in the bloodstream</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <description>Blood clot in the lungs</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <description>Term respiratory failure includes terms respiratory failure, acute respiratory failure and chronic respiratory failure</description>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA v.23.1</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="47" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <description>Not enough red blood cells</description>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Septic shock</sub_title>
                <description>Shock due to infection</description>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <description>Too much glucose in the bloodstream</description>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <description>Too little potassium in the bloodstream</description>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="44"/>
              </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="3" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <description>Low blood pressure</description>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="44"/>
              </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 only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Limitations include lack of a blinded placebo control and reliance on ABG measurement for estimation of P(A-a)O2 gradient. Some clinical endpoints trial might have been affected by observer bias, availability of hospital or ICU resources, and/or hospital discharge. Missing ABG measurements may have resulted from decreased standard utilization of ABG in recent years, and hospital staff overload due to the COVID-19 pandemic may have led to absent follow-up assessment.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Medical Information</name_or_title>
      <organization>Partner Therapeutics, Inc.</organization>
      <phone>1-888-479-5385</phone>
      <email>PartnerTx@medcomminc.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/NCT04411680
org study id: PTX-001-002
nct id: NCT04411680
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this research is to find out if a drug (sargramostim) also known as Leukine®
      could help patient recover faster from COVID-19. Sargramostim may help the lungs recover from
      the effects of COVID-19, and this research study will help to find this out.
This Phase 2 study is designed as a proof of concept study and will randomize 2:1
      approximately 120 patients with COVID-19 associated acute hypoxemia: of which 80 patients
      will receive sargramostim plus standard of care, and 40 patients who will receive standard of
      care alone. The aim of the study is to determine if inhaled sargramostim, as an adjunct to
      institutional standard of care, improves clinical outcomes in patients with
      COVID-19-associated acute hypoxemia. All patients on the sargramostim arm will be treated
      with 125 mcg inhaled sargramostim twice daily for 5 days, in addition to institutional
      standard of care. If required, upon progression to an invasive mechanical ventilator,
      administration of sargramostim may be delivered by intravenous infusion to complete a total
      of 5 days (including days delivered via inhalation).

      GM-CSF is a critical cytokine for healthy pulmonary function and is necessary for the
      maturation and maintenance of alveolar macrophages. Preclinical studies have shown GM-CSF
      confers resistance to influenza by enhancing innate immune mechanisms that depend on alveolar
      macrophages for their health and normal functioning. Clinical studies of sargramostim in
      patients with severe sepsis and respiratory dysfunction or acute respiratory distress
      syndrome have shown improvements in oxygenation and lung compliance.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This Phase 2, randomized, open-label study will enroll approximately 120 patients with COVID-19 associated acute hypoxemia. It is a randomized 2:1 study to evaluate sargramostim treatment plus institutional standard of care compared to institutional standard of care alone.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Oxygenation Parameter of P(A-a)O2 Gradient by Day 6
time frame: 1-6 days
description: The P(A-a)O2 gradient is a measure of how well the oxygen moves from the lungs into the bloodstream. Patients with a high gradient have less oxygen in the bloodstream.
measure: Number of Patients Who Have Been Intubated by Day 14
time frame: 1-14 days
measure: Change in Ordinal Scale
time frame: 1-28 days
description: The ordinal scale was used, where 0 is not hospitalized, no clinical or virological evidence of infection, and 8 is death.
measure: All Cause 28-day Mortality
time frame: 1-28 days
measure: Number of Patients With Treatment-related Adverse Events
time frame: 1-58 days
description: Number of patients with side effects related to treatment with sargramostim. Patients on the control arm did not receive sargramostim.
measure: Survival Time of Patients
time frame: Day 1-90
measure: Causes of Death
time frame: Day 1-90
measure: Change From Baseline in P/F Ratio
time frame: From Day 1 up to Day 6
description: The P/F ratio is a simple way to assess severity of low blood oxygen. It's the ratio of PaO2 (arterial oxygen partial pressure obtained from an arterial blood gas) to FiO2 (fraction of inspired oxygen expressed as a decimal). A normal arterial blood is gas 80 to 100 mm Hg. Normal room air has 21% or 0.21 oxygen. So a "normal" P/F ratio is about 380-475. A high P/F ratio means more oxygen in the bloodstream and a low P/F ratio means less oxygen in the bloodstream.
This outcome measure compares the improvement (increase) in P/F ratio between treatment arms.
measure: Number of Participants Wtih Nosocomial Infections
time frame: Day 1-90
description: Nosocomial infections also referred to as healthcare-associated infections (HAI), are infection(s) acquired during the process of receiving health care that was not present during the time of admission.
measure: Number of Patients Requiring Invasive Mechanical Ventilation
time frame: Day 1-90
description: The is the number of patients that needed to be placed on a ventilator.
measure: Duration of Invasive, Non-invasive and Supplemental Oxygen
time frame: Day 1-90
description: This endpoint includes duration of any/all types of respiratory support
measure: Duration of Hospitalization
time frame: Day 1-90
measure: Time to Normalization of White Blood Cells and Lymphocytes
time frame: Day 1-90
description: Normalization of WBC and lymphocyte count is defined as whether WBC and lymphocyte count results are normal or below normal or above normal ranges at available visits.
arm group label: Sargramostim Arm
arm group type: Experimental
description: Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19
arm group label: Control Arm
arm group type: Active Comparator
description: Standard of care for COVID-19
intervention type: Drug
intervention name: Sargramostim
description: Sargramostim is a glycosylated, yeast-derived recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.
arm group label: Sargramostim Arm
other name: Leukine
other name: GM-CSF
intervention type: Drug
intervention name: Standard of care
description: Standard of care for COVID-19
arm group label: Control Arm
arm group label: Sargramostim Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Information
role: Study Director
affiliation: Partner Therapeutics, Inc.
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country: United States
citation: Paine R, Chasse R, Halstead ES, Nfonoyim J, Park DJ, Byun T, Patel B, Molina-Pallete G, Harris ES, Garner F, Simms L, Ahuja S, McManus JL, Roychowdhury DF. Inhaled Sargramostim (Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor) for COVID-19-Associated Acute Hypoxemia: Results of the Phase 2, Randomized, Open-Label Trial (iLeukPulm). Mil Med. 2022 Dec 2;188(7-8):e2629-38. doi: 10.1093/milmed/usac362. Online ahead of print.
PMID: 36458916
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Sargramostim
sharing ipd: No
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participant flow: 
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reported events: 
certain agreements: 
limitations and caveats: Limitations include lack of a blinded placebo control and reliance on ABG measurement for estimation of P(A-a)O2 gradient. Some clinical endpoints trial might have been affected by observer bias, availability of hospital or ICU resources, and/or hospital discharge. Missing ABG measurements may have resulted from decreased standard utilization of ABG in recent years, and hospital staff overload due to the COVID-19 pandemic may have led to absent follow-up assessment.
point of contact: 