<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/NCT04401527</url>
  </required_header>
  <id_info>
    <org_study_id>SN02-01</org_study_id>
    <nct_id>NCT04401527</nct_id>
  </id_info>
  <brief_title>Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite</brief_title>
  <official_title>Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hope Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hope Pharmaceuticals</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 multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate&#xD;
      the efficacy and safety of intravenous Sodium Nitrite Injection for treatment of patients&#xD;
      infected with COVID-19 who develop lung injury and require mechanical ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This Phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial will&#xD;
      evaluate the efficacy and safety of intravenous Sodium Nitrite Injection for treatment of&#xD;
      patients infected with COVID-19 who develop lung injury and require mechanical ventilation.&#xD;
      The primary objective is to compare the two treatment groups with respect to the proportion&#xD;
      of study subjects who are alive and free of respiratory failure at Day 28.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">July 22, 2020</start_date>
  <completion_date type="Actual">August 15, 2020</completion_date>
  <primary_completion_date type="Actual">August 15, 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>Survival with Unassisted Breathing</measure>
    <time_frame>Day 28</time_frame>
    <description>Proportion of study subjects who are alive and free of respiratory failure at Day 28</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival without Mechanical Ventilation</measure>
    <time_frame>Day 28</time_frame>
    <description>Number of days alive without mechanical ventilation from start of study through Day 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival without Intensive Care</measure>
    <time_frame>Day 28</time_frame>
    <description>Number of days alive and not in the intensive care unit from start of study through Day 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival without Hospitalization</measure>
    <time_frame>Day 28</time_frame>
    <description>Number of days alive and not in hospital from start of study through Day 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival without ECMO</measure>
    <time_frame>Day 28</time_frame>
    <description>Alive on Day 28 and no use of ECMO therapy any time between start of study and Day 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>Day 28</time_frame>
    <description>Alive on Day 28</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Lung Status</measure>
    <time_frame>Day 14</time_frame>
    <description>Oxygenation index (PaO2/FIO2) at Day 14</description>
  </other_outcome>
  <other_outcome>
    <measure>Kidney Status (1)</measure>
    <time_frame>Day 14</time_frame>
    <description>Blood urea nitrogen (BUN) at Day 14</description>
  </other_outcome>
  <other_outcome>
    <measure>Kidney Status (2)</measure>
    <time_frame>Day 14</time_frame>
    <description>Creatinine at Day 14</description>
  </other_outcome>
  <other_outcome>
    <measure>Liver Status</measure>
    <time_frame>Day 14</time_frame>
    <description>Liver function tests (ALT and AST) at Day 14</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID-19</condition>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <condition>Acute Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>Sodium Nitrite</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hope Pharmaceuticals' Sodium Nitrite Injection administered by continuous intravenous infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0.9% Sodium Chloride Injection, USP (normal saline) administered by continuous intravenous infusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium Nitrite</intervention_name>
    <description>Continuous intravenous infusion of Sodium Nitrite Injection</description>
    <arm_group_label>Sodium Nitrite</arm_group_label>
    <other_name>Hope Pharmaceuticals Sodium Nitrite Injection USP 30 mg/mL</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>Continuous intravenous infusion of Normal Saline</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years of age or older;&#xD;
&#xD;
          2. Diagnosed COVID-19 disease with confirmed SARS-coV-2 viral infection;&#xD;
&#xD;
          3. Able to sign the informed consent form (ICF) or next of kin/legal guardian able to&#xD;
             sign informed consent;&#xD;
&#xD;
          4. Randomization within 24 hours of intubation and mechanical ventilation due to&#xD;
             respiratory failure from COVID-19 infection;&#xD;
&#xD;
          5. Absolute lymphocyte count &gt; 800 / mm3;&#xD;
&#xD;
          6. Women of childbearing potential (WCBP) must have a negative urine or serum (if anuric)&#xD;
             pregnancy test at screening;&#xD;
&#xD;
          7. WCBP must agree to abstain from sex or use an adequate method of contraception from&#xD;
             the time of informed consent through Day 28;&#xD;
&#xD;
          8. Males must abstain from sex with WCBP or use an adequate method of contraception from&#xD;
             the time of informed consent through Day 28.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Methemoglobinemia &gt; 2%;&#xD;
&#xD;
          2. Hypotension with systemic blood pressure &lt; 90/60 mm Hg, or uncontrolled hypotension&#xD;
             despite vasopressor support;&#xD;
&#xD;
          3. History of sickle cell disease, thalassemia, G6PD deficiency, lung transplant, or&#xD;
             allergy to sodium nitrite;&#xD;
&#xD;
          4. Hemoglobin &lt; 8 gm/dL;&#xD;
&#xD;
          5. Renal impairment with creatinine clearance &lt; 60 mL/min/1.73m2;&#xD;
&#xD;
          6. Treatment within the past 48 hours with allopurinol (a medication that could interfere&#xD;
             with nitrite metabolism);&#xD;
&#xD;
          7. Treatment within the past 24 hours with organic nitrates such as nitroglycerin,&#xD;
             isosorbide mononitrate, isosorbide dinitrate, sodium nitroprusside, and inhaled nitric&#xD;
             oxide;&#xD;
&#xD;
          8. Treatment within the past 24 hours with lidocaine, prilocaine, benzocaine, and&#xD;
             dapsone;&#xD;
&#xD;
          9. Requiring extracorporeal membrane oxygenation (ECMO);&#xD;
&#xD;
         10. Subjects with bacterial or fungal infections except for mild cutaneous infections or&#xD;
             sinus infections;&#xD;
&#xD;
         11. Subjects who are pregnant or lactating;&#xD;
&#xD;
         12. Any condition that, in the opinion of the Investigator, places the subject at&#xD;
             unacceptable risk if he/she were to participate in the study;&#xD;
&#xD;
         13. Clinically relevant serious co-morbid medical conditions including, but not limited&#xD;
             to, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension,&#xD;
             uncontrolled cardiac arrhythmias, uncontrolled chronic obstructive or chronic&#xD;
             restrictive pulmonary disease, active central nervous system (CNS) disease&#xD;
             uncontrolled by standard of care, known positive status for human immunodeficiency&#xD;
             virus (HIV) (except if HIV subject has undetectable viral load and a CD4 count of ≥&#xD;
             500 cells/µL), and/or active hepatitis B or C, cirrhosis, or uncontrolled psychiatric&#xD;
             illness/social situations that would limit compliance with study requirements;&#xD;
&#xD;
         14. Treatment within 30 days or 5 half-lives of that agent (whichever is shorter) before&#xD;
             the first study drug dose using another investigational drug. Notwithstanding,&#xD;
             prospective subjects who receive any of the following drugs or treatments before the&#xD;
             first study drug dose or during this study may be considered for participation in this&#xD;
             study: (1) a commercially available, FDA-approved drug or treatment used off-label for&#xD;
             the treatment of COVID-19, or (2) a drug or treatment that has FDA Emergency Use&#xD;
             Authorization for the treatment of COVID-19 patients;&#xD;
&#xD;
         15. Moribund or not expected to survive 48 hours.&#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>Hope Pharmaceuticals Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Hope Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Participating Research Facility</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Participating Research Facility</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>May 21, 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>September 11, 2020</last_update_submitted>
  <last_update_submitted_qc>September 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Acute Respiratory Distress Syndrome</keyword>
  <keyword>Acute Respiratory Failure</keyword>
  <keyword>ARDS</keyword>
  <keyword>Respiratory Failure</keyword>
  <keyword>Intubation</keyword>
  <keyword>Mechanical Ventilation</keyword>
  <keyword>Intubated</keyword>
  <keyword>Mechanical Ventilator</keyword>
  <keyword>ECMO</keyword>
  <keyword>Sodium Nitrite</keyword>
  <keyword>Nitrite</keyword>
  <keyword>Nitric Oxide</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>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Lung Injury</mesh_term>
  </condition_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/NCT04401527
org study id: SN02-01
nct id: NCT04401527
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate
      the efficacy and safety of intravenous Sodium Nitrite Injection for treatment of patients
      infected with COVID-19 who develop lung injury and require mechanical ventilation.
This Phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial will
      evaluate the efficacy and safety of intravenous Sodium Nitrite Injection for treatment of
      patients infected with COVID-19 who develop lung injury and require mechanical ventilation.
      The primary objective is to compare the two treatment groups with respect to the proportion
      of study subjects who are alive and free of respiratory failure at Day 28.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Survival with Unassisted Breathing
time frame: Day 28
description: Proportion of study subjects who are alive and free of respiratory failure at Day 28
measure: Survival without Mechanical Ventilation
time frame: Day 28
description: Number of days alive without mechanical ventilation from start of study through Day 28
measure: Survival without Intensive Care
time frame: Day 28
description: Number of days alive and not in the intensive care unit from start of study through Day 28.
measure: Survival without Hospitalization
time frame: Day 28
description: Number of days alive and not in hospital from start of study through Day 28.
measure: Survival without ECMO
time frame: Day 28
description: Alive on Day 28 and no use of ECMO therapy any time between start of study and Day 28.
measure: Survival
time frame: Day 28
description: Alive on Day 28
measure: Lung Status
time frame: Day 14
description: Oxygenation index (PaO2/FIO2) at Day 14
measure: Kidney Status (1)
time frame: Day 14
description: Blood urea nitrogen (BUN) at Day 14
measure: Kidney Status (2)
time frame: Day 14
description: Creatinine at Day 14
measure: Liver Status
time frame: Day 14
description: Liver function tests (ALT and AST) at Day 14
arm group label: Sodium Nitrite
arm group type: Active Comparator
description: Hope Pharmaceuticals' Sodium Nitrite Injection administered by continuous intravenous infusion.
arm group label: Placebo
arm group type: Placebo Comparator
description: 0.9% Sodium Chloride Injection, USP (normal saline) administered by continuous intravenous infusion.
intervention type: Drug
intervention name: Sodium Nitrite
description: Continuous intravenous infusion of Sodium Nitrite Injection
arm group label: Sodium Nitrite
other name: Hope Pharmaceuticals Sodium Nitrite Injection USP 30 mg/mL
intervention type: Drug
intervention name: Normal Saline
description: Continuous intravenous infusion of Normal Saline
arm group label: Placebo
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hope Pharmaceuticals Medical Director
role: Study Director
affiliation: Hope Pharmaceuticals
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Respiratory Insufficiency
mesh term: Acute Lung Injury
mesh term: Lung Injury