<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/NCT04400929</url>
  </required_header>
  <id_info>
    <org_study_id>SH-Leuk-01</org_study_id>
    <nct_id>NCT04400929</nct_id>
  </id_info>
  <brief_title>Using GM-CSF as a Host Directed Therapeutic Against COVID-19</brief_title>
  <official_title>Using GM-CSF as a Host Directed Therapeutic Against COVID-19 - a Phase 2 Investigator Initiated Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Singapore General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Singapore General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The coronavirus disease 2019 (COVID-19) has rapidly become a pandemic. COVID-19 poses a&#xD;
      mortality risk of 3-7%, rising to 20% in older patients with co-morbidities. Of all infected&#xD;
      patients, 15-20% will develop severe respiratory symptoms necessitating hospital admission.&#xD;
      Around 5% of patients will require invasive mechanical ventilation, and up to 50% will die.&#xD;
&#xD;
      Evidence in severe COVID-19 suggests that these patients experience cytokine storm and&#xD;
      progressed rapidly with acute respiratory distress syndrome and eventual multi-organ failure.&#xD;
      Early identification and immediate treatment of hyperinflammation is thus recommended to&#xD;
      reduce mortality. Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) has been shown to&#xD;
      be a myelopoietic growth factor that has pleiotropic effects in promoting the differentiation&#xD;
      of immature precursors into polymorphonuclear neutrophils, monocytes/ macrophages and&#xD;
      dendritic cells, and also in controlling the function of fully mature myeloid cells. It plays&#xD;
      an important role in priming monocytes for production of proinflammatory cytokines under TLR&#xD;
      and NLR stimulation. It has a broad impact on the processes driving DC differentiation and&#xD;
      affects DC effector function at the mature state. Importantly, GM-CSF plays a critical role&#xD;
      in host defense and stimulating antiviral immunity. Detailed studies have also shown that&#xD;
      GM-CSF is necessary for the maturation of alveolar macrophages from foetal monocytes and the&#xD;
      maintenance of these cells in adulthood. The known toxicology, pharmacologic and safety data&#xD;
      also support the use of Leukine® in hypoxic respiratory failure and ARDS due to COVID-19.&#xD;
&#xD;
      This study aims to recruit patients with evidence of pneumonia and hypoxia who have increased&#xD;
      risk for severe disease and need for mechanical ventilation. The overall hypothesis is that&#xD;
      GM-CSF has antiviral immunity, can provide the stimulus to restore immune homeostasis in the&#xD;
      lung with acute lung injury from COVID-19, and can promote lung repair mechanisms, which&#xD;
      would lead to improvement in lung oxygenation parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The hypothesis of the proposed intervention is that GM-CSF has profound effects on antiviral&#xD;
      immunity, can provide the stimulus to restore immune homeostasis in the lung with acute lung&#xD;
      injury post COVID-19, and can promote lung repair mechanisms, which would lead to an&#xD;
      improvement in lung oxygenation parameters. This hypothesis is based on experiments performed&#xD;
      in mice showing that GM-CSF treatment can prevent mortality and prevent ARDS in mice with&#xD;
      post-viral acute lung injury.&#xD;
&#xD;
      In the interim analysis of the SARPAC trial, patients who received nebulised Leukine® via a&#xD;
      mesh inhaler showed a trend in improvement in their P(A-a)O2 gradient at day 6 compared to&#xD;
      the SOC group. There are however, anticipated logistical difficulties of training and&#xD;
      infection control concerns with administering of nebulised Leukine® via a specialised inhaler&#xD;
      in the negative pressure room. Hence we propose to randomize patients with confirmed COVID-19&#xD;
      and acute hypoxic respiratory failure (saturation &lt; 94% on room air or PaO2/FiO2 &lt;350) to&#xD;
      receive iv Leukine® 125mcg/m2 once a day for 5 days on top of SOC (treatment group A), or to&#xD;
      receive SOC treatment only (placebo group B). Dosing of systemic Leukine® is based on prior&#xD;
      experience of using this drug in patients with pneumonia-associated ARDS.&#xD;
&#xD;
      To measure the effectiveness of Leukine® in restoring lung homeostasis, the primary endpoint&#xD;
      of this intervention is measuring oxygenation after 5 days of intravenous treatment through&#xD;
      assessment of pre-treatment and post-treatment ratio of PaO2/FiO2, and through measurement of&#xD;
      the P(A-a)O2 gradient, which can easily be performed in the setting of clinical observation&#xD;
      of inpatients. During the 5-day treatment period, we will perform daily measurements of&#xD;
      oxygen saturation (pulse oximetry) in relation to FiO2, and the slope of alterations in these&#xD;
      parameters could also be an indicator that our hypothesis is correct.&#xD;
&#xD;
      Comparison will be between group A receiving iv Leukine® on top of standard of care (SOC) and&#xD;
      placebo group B receiving SOC only. Data from the Wuhan COVID-19 epidemic show that patients&#xD;
      that deteriorate are facing a prolonged period of mechanical ventilation. Therefore, the&#xD;
      study will be unblinded at day 5, or at any time within the first 5 days of study should the&#xD;
      patient deteriorate clinically with need for supplemental oxygen FiO2 requirement ≥ 0.5.&#xD;
      Patients in group B will then have the option to receive 5 days of iv Leukine®, based on the&#xD;
      treating physician's assessment. This group will be group D. Patients who require mechanical&#xD;
      ventilation also have the option to receive an additional 5 days of iv Leukine®, based on the&#xD;
      treating physician's assessment (group C and E).&#xD;
&#xD;
      A total of 30 patients with confirmed COVID-19 and acute hypoxic respiratory failure will be&#xD;
      enrolled, 15 who will receive Leukine® + SOC, and 15 who will receive placebo + SOC. The&#xD;
      target group of subjects is defined as confirmed COVID-19 patients with acute hypoxic&#xD;
      respiratory failure admitted to the COVID-19 isolation ward. Subjects will be recruited from&#xD;
      the isolation wards located in Singapore General Hospital (SGH). Subjects will be identified&#xD;
      by the primary managing physicians who are infectious diseases physicians.&#xD;
&#xD;
      Safety data, including blood leukocyte counts, will be collected in all patients. Efficacy&#xD;
      data will also be collected and will include arterial blood gases, oxygenation parameters,&#xD;
      need for ventilation, lung compliance, organ function, radiographic changes, ferritin levels,&#xD;
      triglyceride levels, etc. as well as occurrence of secondary bacterial infections.&#xD;
&#xD;
      Patients will stop the investigational drug if there is unacceptable toxicity according to&#xD;
      investigator's judgement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2, 2020</start_date>
  <completion_date type="Actual">February 4, 2022</completion_date>
  <primary_completion_date type="Actual">January 26, 2022</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 is a randomized, double-blind, placebo-controlled clinical trial of iv Leukine® in 30 patients with confirmed COVID-19 and acute hypoxic respiratory failure.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>This is a double-blind study to investigate immediate versus delayed treatment of iv Leukine® in improving oxygenation and short- and long-term outcome of COVID-19 patients with acute hypoxic respiratory failure. The study will be unblinded at Day 5, or at any time within the first 5 days of study should the patient deteriorate clinically with need for supplemental oxygen FiO2 requirement ≥ 0.5.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Measuring oxygenation</measure>
    <time_frame>Day 1 to Day 6</time_frame>
    <description>To measure the effectiveness of Leukine® in restoring lung homeostasis, the primary endpoint of this intervention is measuring oxygenation after 5 days of intravenous treatment through assessment of pre-treatment and post-treatment ratio of PaO2/FiO2, and through measurement of the P(A-a)O2 gradient, which can easily be performed in the setting of clinical observation of inpatients.</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>COVID</condition>
  <condition>Sars-CoV2</condition>
  <condition>ARDS, Human</condition>
  <arm_group>
    <arm_group_label>Group A: Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1 - 5: Receive study medication Leukine® 125mcg/m2 body surface area daily (via infusion into the vein) in addition to standard of care treatments</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B: Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Day 1 - 5: Receive normal saline 0.9% daily (via infusion into the vein) in addition to standard of care treatments</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 6 - 10: Subjects in Group A who require mechanical ventilation to receive an additional 5 days of IV Leukine® 125mcg/m2 body surface area daily, in addition to standard of care treatments (based on the treating physician's assessment)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 6 - 10: Subjects from Group B to receive study medication (based on the treating physician's assessment), Leukine® 125mcg/m2 body surface area daily (via infusion into the vein) in addition to standard of care treatments</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 11 - 15: Subjects in Group D who require mechanical ventilation to receive an additional 5 days of IV Leukine® 125mcg/m2 body surface area daily, in addition to standard of care treatments (based on the treating physician's assessment)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sargramostim</intervention_name>
    <description>Dosage for IV Leukine® injection: 125mcg/m2/day over a 4-hour period for up to 5 days.</description>
    <arm_group_label>Group A: Treatment Group</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_label>Group E</arm_group_label>
    <other_name>GM-CSF</other_name>
    <other_name>Granulocyte-Macrophage Colony Stimulating Factor</other_name>
    <other_name>Leukine®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal Saline 0.9%</intervention_name>
    <description>IV normal saline 0.9% for 5 days</description>
    <arm_group_label>Group B: Placebo Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  SARS-CoV-2 PCR-confirmed COVID-19 infection&#xD;
&#xD;
          -  Presence of acute hypoxic respiratory failure defined as (either or both)&#xD;
&#xD;
          -  Saturation &lt; 94% on room air or requiring supplemental oxygen&#xD;
&#xD;
          -  PaO2/FiO2 below 350&#xD;
&#xD;
          -  Age 21-80&#xD;
&#xD;
          -  Able and willing to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are already on supplemental oxygen of FiO2 ≥ 0.4&#xD;
&#xD;
          -  Patients with known history of serious allergic reactions, including anaphylaxis, to&#xD;
             human GM-CSF such as Leukine®, yeast-derived products, or any component of the&#xD;
             product.&#xD;
&#xD;
          -  Mechanical ventilation before start of study&#xD;
&#xD;
          -  Patients enrolled in another investigational drug study&#xD;
&#xD;
          -  Pregnant or breastfeeding females (all female subjects of childbearing potential&#xD;
             status must have negative pregnancy test at screening)&#xD;
&#xD;
          -  Patients with peripheral white blood cell count above 25,000 per microliter and/or&#xD;
             active myeloid malignancy&#xD;
&#xD;
          -  Patients on high dose systemic steroids (&gt; 20mg methylprednisolone or equivalent)&#xD;
&#xD;
          -  Patients on lithium carbonate therapy&#xD;
&#xD;
          -  Patients with serum ferritin &gt;2000 mcg/ml (which will exclude ongoing HLH)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jenny Low, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Singapore General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Singapore General Hospital</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
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    <citation>Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.</citation>
    <PMID>32091533</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>May 8, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 8, 2022</last_update_submitted>
  <last_update_submitted_qc>May 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pandemic</keyword>
  <keyword>host-directed therapeutic</keyword>
  <keyword>GM-CSF</keyword>
  <keyword>COVID-19</keyword>
  <keyword>ARDS</keyword>
  <keyword>SARS-CoV2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Molgramostim</mesh_term>
    <mesh_term>Sargramostim</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>April 13, 2023</submitted>
    <returned>May 3, 2023</returned>
    <submitted>May 4, 2023</submitted>
    <returned>May 31, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04400929
org study id: SH-Leuk-01
nct id: NCT04400929
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The coronavirus disease 2019 (COVID-19) has rapidly become a pandemic. COVID-19 poses a
      mortality risk of 3-7%, rising to 20% in older patients with co-morbidities. Of all infected
      patients, 15-20% will develop severe respiratory symptoms necessitating hospital admission.
      Around 5% of patients will require invasive mechanical ventilation, and up to 50% will die.

      Evidence in severe COVID-19 suggests that these patients experience cytokine storm and
      progressed rapidly with acute respiratory distress syndrome and eventual multi-organ failure.
      Early identification and immediate treatment of hyperinflammation is thus recommended to
      reduce mortality. Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) has been shown to
      be a myelopoietic growth factor that has pleiotropic effects in promoting the differentiation
      of immature precursors into polymorphonuclear neutrophils, monocytes/ macrophages and
      dendritic cells, and also in controlling the function of fully mature myeloid cells. It plays
      an important role in priming monocytes for production of proinflammatory cytokines under TLR
      and NLR stimulation. It has a broad impact on the processes driving DC differentiation and
      affects DC effector function at the mature state. Importantly, GM-CSF plays a critical role
      in host defense and stimulating antiviral immunity. Detailed studies have also shown that
      GM-CSF is necessary for the maturation of alveolar macrophages from foetal monocytes and the
      maintenance of these cells in adulthood. The known toxicology, pharmacologic and safety data
      also support the use of Leukine® in hypoxic respiratory failure and ARDS due to COVID-19.

      This study aims to recruit patients with evidence of pneumonia and hypoxia who have increased
      risk for severe disease and need for mechanical ventilation. The overall hypothesis is that
      GM-CSF has antiviral immunity, can provide the stimulus to restore immune homeostasis in the
      lung with acute lung injury from COVID-19, and can promote lung repair mechanisms, which
      would lead to improvement in lung oxygenation parameters.
The hypothesis of the proposed intervention is that GM-CSF has profound effects on antiviral
      immunity, can provide the stimulus to restore immune homeostasis in the lung with acute lung
      injury post COVID-19, and can promote lung repair mechanisms, which would lead to an
      improvement in lung oxygenation parameters. This hypothesis is based on experiments performed
      in mice showing that GM-CSF treatment can prevent mortality and prevent ARDS in mice with
      post-viral acute lung injury.

      In the interim analysis of the SARPAC trial, patients who received nebulised Leukine® via a
      mesh inhaler showed a trend in improvement in their P(A-a)O2 gradient at day 6 compared to
      the SOC group. There are however, anticipated logistical difficulties of training and
      infection control concerns with administering of nebulised Leukine® via a specialised inhaler
      in the negative pressure room. Hence we propose to randomize patients with confirmed COVID-19
      and acute hypoxic respiratory failure (saturation < 94% on room air or PaO2/FiO2 <350) to
      receive iv Leukine® 125mcg/m2 once a day for 5 days on top of SOC (treatment group A), or to
      receive SOC treatment only (placebo group B). Dosing of systemic Leukine® is based on prior
      experience of using this drug in patients with pneumonia-associated ARDS.

      To measure the effectiveness of Leukine® in restoring lung homeostasis, the primary endpoint
      of this intervention is measuring oxygenation after 5 days of intravenous treatment through
      assessment of pre-treatment and post-treatment ratio of PaO2/FiO2, and through measurement of
      the P(A-a)O2 gradient, which can easily be performed in the setting of clinical observation
      of inpatients. During the 5-day treatment period, we will perform daily measurements of
      oxygen saturation (pulse oximetry) in relation to FiO2, and the slope of alterations in these
      parameters could also be an indicator that our hypothesis is correct.

      Comparison will be between group A receiving iv Leukine® on top of standard of care (SOC) and
      placebo group B receiving SOC only. Data from the Wuhan COVID-19 epidemic show that patients
      that deteriorate are facing a prolonged period of mechanical ventilation. Therefore, the
      study will be unblinded at day 5, or at any time within the first 5 days of study should the
      patient deteriorate clinically with need for supplemental oxygen FiO2 requirement ≥ 0.5.
      Patients in group B will then have the option to receive 5 days of iv Leukine®, based on the
      treating physician's assessment. This group will be group D. Patients who require mechanical
      ventilation also have the option to receive an additional 5 days of iv Leukine®, based on the
      treating physician's assessment (group C and E).

      A total of 30 patients with confirmed COVID-19 and acute hypoxic respiratory failure will be
      enrolled, 15 who will receive Leukine® + SOC, and 15 who will receive placebo + SOC. The
      target group of subjects is defined as confirmed COVID-19 patients with acute hypoxic
      respiratory failure admitted to the COVID-19 isolation ward. Subjects will be recruited from
      the isolation wards located in Singapore General Hospital (SGH). Subjects will be identified
      by the primary managing physicians who are infectious diseases physicians.

      Safety data, including blood leukocyte counts, will be collected in all patients. Efficacy
      data will also be collected and will include arterial blood gases, oxygenation parameters,
      need for ventilation, lung compliance, organ function, radiographic changes, ferritin levels,
      triglyceride levels, etc. as well as occurrence of secondary bacterial infections.

      Patients will stop the investigational drug if there is unacceptable toxicity according to
      investigator's judgement.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a randomized, double-blind, placebo-controlled clinical trial of iv Leukine® in 30 patients with confirmed COVID-19 and acute hypoxic respiratory failure.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: This is a double-blind study to investigate immediate versus delayed treatment of iv Leukine® in improving oxygenation and short- and long-term outcome of COVID-19 patients with acute hypoxic respiratory failure. The study will be unblinded at Day 5, or at any time within the first 5 days of study should the patient deteriorate clinically with need for supplemental oxygen FiO2 requirement ≥ 0.5.
measure: Measuring oxygenation
time frame: Day 1 to Day 6
description: To measure the effectiveness of Leukine® in restoring lung homeostasis, the primary endpoint of this intervention is measuring oxygenation after 5 days of intravenous treatment through assessment of pre-treatment and post-treatment ratio of PaO2/FiO2, and through measurement of the P(A-a)O2 gradient, which can easily be performed in the setting of clinical observation of inpatients.
arm group label: Group A: Treatment Group
arm group type: Experimental
description: Day 1 - 5: Receive study medication Leukine® 125mcg/m2 body surface area daily (via infusion into the vein) in addition to standard of care treatments
arm group label: Group B: Placebo Group
arm group type: Placebo Comparator
description: Day 1 - 5: Receive normal saline 0.9% daily (via infusion into the vein) in addition to standard of care treatments
arm group label: Group C
arm group type: Experimental
description: Day 6 - 10: Subjects in Group A who require mechanical ventilation to receive an additional 5 days of IV Leukine® 125mcg/m2 body surface area daily, in addition to standard of care treatments (based on the treating physician's assessment)
arm group label: Group D
arm group type: Experimental
description: Day 6 - 10: Subjects from Group B to receive study medication (based on the treating physician's assessment), Leukine® 125mcg/m2 body surface area daily (via infusion into the vein) in addition to standard of care treatments
arm group label: Group E
arm group type: Experimental
description: Day 11 - 15: Subjects in Group D who require mechanical ventilation to receive an additional 5 days of IV Leukine® 125mcg/m2 body surface area daily, in addition to standard of care treatments (based on the treating physician's assessment)
intervention type: Drug
intervention name: Sargramostim
description: Dosage for IV Leukine® injection: 125mcg/m2/day over a 4-hour period for up to 5 days.
arm group label: Group A: Treatment Group
arm group label: Group C
arm group label: Group D
arm group label: Group E
other name: GM-CSF
other name: Granulocyte-Macrophage Colony Stimulating Factor
other name: Leukine®
intervention type: Other
intervention name: Normal Saline 0.9%
description: IV normal saline 0.9% for 5 days
arm group label: Group B: Placebo Group
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jenny Low, MBBS
role: Principal Investigator
affiliation: Singapore General Hospital
facility: 
country: Singapore
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PMID: 32091533
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Respiratory Distress Syndrome
mesh term: Molgramostim
mesh term: Sargramostim
submitted: April 13, 2023
returned: May 3, 2023
submitted: May 4, 2023
returned: May 31, 2023