<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/NCT04433546</url>
  </required_header>
  <id_info>
    <org_study_id>PB1046-PT-CL-0007</org_study_id>
    <nct_id>NCT04433546</nct_id>
  </id_info>
  <brief_title>Pemziviptadil (PB1046), a Long-acting, Sustained Release Human VIP Analogue, Intended to Provide Clinical Improvement to Hospitalized COVID-19 Patients at High Risk for Rapid Clinical Deterioration and Acute Respiratory Distress Syndrome (ARDS).</brief_title>
  <acronym>VANGARD</acronym>
  <official_title>A Randomized, Double-Blind, Parallel Group Study to Assess the Efficacy and Safety of Once Weekly Subcutaneous Injections of Pemziviptadil (PB1046), a Sustained-Release VIP (Vasoactive Intestinal Peptide) ANalogue, in Hospitalized COVID-19 Patients at HiGh Risk for Rapid Clinical Deterioration and ARDS (PB1046 VANGARD Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PhaseBio Pharmaceuticals Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PhaseBio Pharmaceuticals Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, randomized, double-blind, parallel group study to investigate the&#xD;
      efficacy of pemziviptadil (PB1046) by improving the clinical outcomes in hospitalized&#xD;
      COVID-19 patients at high risk for rapid clinical deterioration, acute respiratory distress&#xD;
      syndrome (ARDS) and death.&#xD;
&#xD;
      The study will enroll approximately 210 hospitalized COVID-19 patients who require urgent&#xD;
      decision-making and treatment at approximately 20 centers in the United States.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will consist of a Screening/Pre-treatment period, on-site randomization to study&#xD;
      treatment. On Day 0 (Visit 2) subjects who meet inclusion criteria and none of exclusion&#xD;
      criteria will receive a weekly subcutaneous injection that will continue once weekly until&#xD;
      hospital discharge or for a maximum of 4 weeks during hospitalization, whichever is shorter.&#xD;
&#xD;
      All subjects will be randomized to either a low control (10 mg), middle (40 mg), or high (100&#xD;
      mg) dose of active treatment. If subject is not discharged, they will continue to Day 7, 14,&#xD;
      21 treatments. Pemziviptadil (PB1046) is expected to improve the clinical outcomes of&#xD;
      hospitalized COVID-19 subjects with an earlier hospital discharge and improvement in&#xD;
      survival.&#xD;
&#xD;
      The duration of hospitalization for each subject will be determined by clinical status&#xD;
      independent of study procedures. The estimated duration of the study for each subject,&#xD;
      including screening, is approximately 35+7 days. The subjects may be involved up to 42 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Company no longer pursing indication&#xD;
  </why_stopped>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">December 2, 2020</completion_date>
  <primary_completion_date type="Actual">December 2, 2020</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to clinical recovery from initiation of pemziviptadil (PB1046)</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to clinical recovery (being well enough for hospital discharge or returning to normal baseline activity level prior to discharge)</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to hospital discharge</measure>
    <time_frame>Any time point between injection initiation and Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in hospital resource utilization defined as a composite of: total days: in hospital, in ICU, on ventilator, on ECMO, with invasive hemodynamic monitoring, with mechanical circulatory support, and with inotropic or vasopressor therapy</measure>
    <time_frame>28 days</time_frame>
    <description>Composite of: Total hospital days, Total ICU days, Total days of ventilator use, Total days of ECMO, Total days of invasive hemodynamic monitoring, Total days of mechanical circulatory support, Total days of inotropic or vasopressor therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to clinical improvement as defined by reduction of at least 2 points on an 8-category ordinal scale of clinical improvement or discharge from hospital, whichever comes first.</measure>
    <time_frame>Any time point between injection initiation and Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in cardiac marker troponin I (TrI)</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in cardiac marker NT-proBNP/BNP</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in TNF alpha</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in IL-1</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in IL-6</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by clinical adverse events (AEs) and their relationship to pemziviptadil (PB1046).</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by vital signs and their relationship to pemziviptadil (PB1046)</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by laboratory results and their relationship to pemziviptadil (PB1046)</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by electrocardiogram (ECG) abnormalities and their relationship to pemziviptadil (PB1046)</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by incidence of anti-drug antibodies and their relationship to pemziviptadil (PB1046)</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Impact on invasive hemodynamic parameters as measured by pulmonary artery pressure if patients require right-heart catherization</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Impact on invasive hemodynamic parameters as measured by cardiac output if patients require right-heart catherization</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of multi-system organ failure (MSOF)</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of multi-system organ failure (MSOF) free days</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of subjects requiring extracorporeal membrane oxygenation (ECMO)</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in circulating ferritin</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in circulating D-dimer</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in liver function</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in other blood chemistry</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in hematology</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in inflammatory markers</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in coagulation markers</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percent of clinical failure</measure>
    <time_frame>Any time point between injection initiation and Day 35+7</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <condition>Coronavirus</condition>
  <condition>Hypoxic Respiratory Failure</condition>
  <condition>Hypoxemic Respiratory Failure</condition>
  <condition>Respiratory Complication</condition>
  <condition>Respiratory Insufficiency</condition>
  <condition>Cardiac Dysfunction</condition>
  <condition>Pneumonia</condition>
  <condition>Pulmonary Edema</condition>
  <condition>Pulmonary Inflammation</condition>
  <condition>Respiratory Failure</condition>
  <condition>Cytokine Storm</condition>
  <condition>COVID 19</condition>
  <condition>SARS-CoV-2</condition>
  <condition>Cardiac Event</condition>
  <condition>Cardiac Complication</condition>
  <condition>Cardiac Failure</condition>
  <condition>Cardiac Infarct</condition>
  <arm_group>
    <arm_group_label>High Dose (100 mg) Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High: Pemziviptadil (PB1046) 100 mg subcutaneous (SC) weekly for 4 weeks or until hospital discharge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Middle Dose (40 mg) Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Middle: Pemziviptadil (PB1046) 40 mg SC weekly for 4 weeks or until hospital discharge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Dose (10 mg) Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Low Control: Pemziviptadil (PB1046) 10 mg SC weekly for 4 weeks or until hospital discharge</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemziviptadil (PB1046)</intervention_name>
    <description>Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection</description>
    <arm_group_label>High Dose (100 mg) Group</arm_group_label>
    <arm_group_label>Middle Dose (40 mg) Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low Dose (10 mg) Control</intervention_name>
    <description>Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection (10 mg diluted in sodium chloride to match active drug volume)</description>
    <arm_group_label>Low Dose (10 mg) Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written or witnessed verbal informed consent from patient or remote legal authorized&#xD;
             representative (LAR) or remote family member as permitted by governing local or&#xD;
             central Institutional Review Board (IRB)/independent Ethic Committee (IEC).&#xD;
&#xD;
          2. Male or female 18-85 years old hospitalized COVID-19 patients (positive local&#xD;
             SARS-CoV2 test)&#xD;
&#xD;
          3. Receiving oxygen (O2) by face mask or nasal cannula/prongs and/or with elevated&#xD;
             markers of cardiac injury or dysfunction (hsTnI or NT-proBNP) as assessed by local&#xD;
             testing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects will be excluded from the study if they meet any of the following criteria:&#xD;
&#xD;
          1. Patients considered unsalvageable or expected to expire within 24 hours&#xD;
&#xD;
          2. On mechanical ventilation or imminent need for mechanical ventilation expected in the&#xD;
             next 24 hours&#xD;
&#xD;
          3. Evidence of acute end-organ injury in 2 or more organ systems (not including cardiac&#xD;
             or pulmonary), such as, renal, hepatic, or CNS injury&#xD;
&#xD;
          4. Receiving another investigational therapy for treatment or prevention of&#xD;
             COVID-19-related hypoxemic respiratory failure or ARDS other than antiviral therapy&#xD;
&#xD;
          5. Systolic blood pressure (SBP) &lt; 95 mmHg and/or diastolic blood pressure (DBP) &lt; 50&#xD;
             mmHg or overt symptomatic hypotension during screening&#xD;
&#xD;
          6. Resting heart rate &gt; 110 BPM (beats per minute) during screening&#xD;
&#xD;
          7. Severe chronic renal failure as measured by the estimated glomerular filtration rate&#xD;
             (eGFR) of &lt; 30 mL/min/1.73m2 using the local laboratory calculation of eGFR.&#xD;
&#xD;
          8. Significant liver dysfunction as measured by any one of the following at screening:&#xD;
&#xD;
               -  ALT (Alanine transaminase) &gt; 3.0 times ULN (upper limit of normal)&#xD;
&#xD;
               -  AST (Aspartate transaminase) &gt; 3.0 times ULN&#xD;
&#xD;
               -  Serum bilirubin ≥ 1.6 mg/dL&#xD;
&#xD;
          9. Any in-patient surgical procedure or hospitalization (defined as &gt; 23 hours) within 30&#xD;
             days of subject screening except for prior hospitalization for COVID-19&#xD;
&#xD;
         10. Known hypersensitivity to study drug or any of the excipients of the drug formulation&#xD;
&#xD;
         11. Pregnant or lactating female subjects&#xD;
&#xD;
         12. Any other condition which, in the opinion of the Investigator, would place the subject&#xD;
             at increased risk or would preclude obtaining informed consent or confound the&#xD;
             objectives of study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Baptist Health Research Institute</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarasota Memorial Hospital</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adventist Healthcare White Oak Medical Center</name>
      <address>
        <city>Silver Spring</city>
        <state>Maryland</state>
        <zip>20904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>December 9, 2020</last_update_submitted>
  <last_update_submitted_qc>December 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute Respiratory Distress Syndrome (ARDS)</keyword>
  <keyword>Respiratory distress/failure</keyword>
  <keyword>COVID</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Pulmonary Edema</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Cytokine Release Syndrome</mesh_term>
    <mesh_term>Clinical Deterioration</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>VIP-ELP fusion molecule PB1046</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04433546
org study id: PB1046-PT-CL-0007
nct id: NCT04433546
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a multicenter, randomized, double-blind, parallel group study to investigate the
      efficacy of pemziviptadil (PB1046) by improving the clinical outcomes in hospitalized
      COVID-19 patients at high risk for rapid clinical deterioration, acute respiratory distress
      syndrome (ARDS) and death.

      The study will enroll approximately 210 hospitalized COVID-19 patients who require urgent
      decision-making and treatment at approximately 20 centers in the United States.
The study will consist of a Screening/Pre-treatment period, on-site randomization to study
      treatment. On Day 0 (Visit 2) subjects who meet inclusion criteria and none of exclusion
      criteria will receive a weekly subcutaneous injection that will continue once weekly until
      hospital discharge or for a maximum of 4 weeks during hospitalization, whichever is shorter.

      All subjects will be randomized to either a low control (10 mg), middle (40 mg), or high (100
      mg) dose of active treatment. If subject is not discharged, they will continue to Day 7, 14,
      21 treatments. Pemziviptadil (PB1046) is expected to improve the clinical outcomes of
      hospitalized COVID-19 subjects with an earlier hospital discharge and improvement in
      survival.

      The duration of hospitalization for each subject will be determined by clinical status
      independent of study procedures. The estimated duration of the study for each subject,
      including screening, is approximately 35+7 days. The subjects may be involved up to 42 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time to clinical recovery from initiation of pemziviptadil (PB1046)
time frame: 28 days
measure: Time to clinical recovery (being well enough for hospital discharge or returning to normal baseline activity level prior to discharge)
time frame: 28 days
measure: Time to hospital discharge
time frame: Any time point between injection initiation and Day 28
measure: All-cause mortality
time frame: 28 days
measure: Reduction in hospital resource utilization defined as a composite of: total days: in hospital, in ICU, on ventilator, on ECMO, with invasive hemodynamic monitoring, with mechanical circulatory support, and with inotropic or vasopressor therapy
time frame: 28 days
description: Composite of: Total hospital days, Total ICU days, Total days of ventilator use, Total days of ECMO, Total days of invasive hemodynamic monitoring, Total days of mechanical circulatory support, Total days of inotropic or vasopressor therapy
measure: Time to clinical improvement as defined by reduction of at least 2 points on an 8-category ordinal scale of clinical improvement or discharge from hospital, whichever comes first.
time frame: Any time point between injection initiation and Day 28
measure: Change from baseline in cardiac marker troponin I (TrI)
time frame: Any time point between injection initiation and Day 35+7
measure: Change from baseline in cardiac marker NT-proBNP/BNP
time frame: Any time point between injection initiation and Day 35+7
measure: Change from baseline in TNF alpha
time frame: Any time point between injection initiation and Day 35+7
measure: Change from baseline in IL-1
time frame: Any time point between injection initiation and Day 35+7
measure: Change from baseline in IL-6
time frame: Any time point between injection initiation and Day 35+7
measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by clinical adverse events (AEs) and their relationship to pemziviptadil (PB1046).
time frame: Any time point between injection initiation and Day 35+7
measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by vital signs and their relationship to pemziviptadil (PB1046)
time frame: Any time point between injection initiation and Day 35+7
measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by laboratory results and their relationship to pemziviptadil (PB1046)
time frame: Any time point between injection initiation and Day 35+7
measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by electrocardiogram (ECG) abnormalities and their relationship to pemziviptadil (PB1046)
time frame: Any time point between injection initiation and Day 35+7
measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by incidence of anti-drug antibodies and their relationship to pemziviptadil (PB1046)
time frame: Any time point between injection initiation and Day 35+7
measure: Impact on invasive hemodynamic parameters as measured by pulmonary artery pressure if patients require right-heart catherization
time frame: Any time point between injection initiation and Day 35+7
measure: Impact on invasive hemodynamic parameters as measured by cardiac output if patients require right-heart catherization
time frame: Any time point between injection initiation and Day 35+7
measure: Incidence of multi-system organ failure (MSOF)
time frame: Any time point between injection initiation and Day 35+7
measure: Number of multi-system organ failure (MSOF) free days
time frame: Any time point between injection initiation and Day 35+7
measure: Number of subjects requiring extracorporeal membrane oxygenation (ECMO)
time frame: Any time point between injection initiation and Day 35+7
measure: Change in circulating ferritin
time frame: Any time point between injection initiation and Day 35+7
measure: Change in circulating D-dimer
time frame: Any time point between injection initiation and Day 35+7
measure: Change in liver function
time frame: Any time point between injection initiation and Day 35+7
measure: Change in other blood chemistry
time frame: Any time point between injection initiation and Day 35+7
measure: Change in hematology
time frame: Any time point between injection initiation and Day 35+7
measure: Change in inflammatory markers
time frame: Any time point between injection initiation and Day 35+7
measure: Change in coagulation markers
time frame: Any time point between injection initiation and Day 35+7
measure: Percent of clinical failure
time frame: Any time point between injection initiation and Day 35+7
arm group label: High Dose (100 mg) Group
arm group type: Experimental
description: High: Pemziviptadil (PB1046) 100 mg subcutaneous (SC) weekly for 4 weeks or until hospital discharge
arm group label: Middle Dose (40 mg) Group
arm group type: Experimental
description: Middle: Pemziviptadil (PB1046) 40 mg SC weekly for 4 weeks or until hospital discharge
arm group label: Low Dose (10 mg) Control Group
arm group type: Placebo Comparator
description: Low Control: Pemziviptadil (PB1046) 10 mg SC weekly for 4 weeks or until hospital discharge
intervention type: Drug
intervention name: Pemziviptadil (PB1046)
description: Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection
arm group label: High Dose (100 mg) Group
arm group label: Middle Dose (40 mg) Group
intervention type: Drug
intervention name: Low Dose (10 mg) Control
description: Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection (10 mg diluted in sodium chloride to match active drug volume)
arm group label: Low Dose (10 mg) Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Respiratory Insufficiency
mesh term: Acute Lung Injury
mesh term: Pulmonary Edema
mesh term: Cardiovascular Diseases
mesh term: Heart Failure
mesh term: Syndrome
mesh term: Inflammation
mesh term: Cytokine Release Syndrome
mesh term: Clinical Deterioration
mesh term: VIP-ELP fusion molecule PB1046