<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/NCT04456088</url>
  </required_header>
  <id_info>
    <org_study_id>BAI_COV19_01_CAN</org_study_id>
    <nct_id>NCT04456088</nct_id>
  </id_info>
  <brief_title>Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (CANADA Trial)</brief_title>
  <official_title>Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beyond Air Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beyond Air Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this open label, 2-phase, study is to obtain information on the safety of 80&#xD;
      ppm and the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of&#xD;
      care of patients with COVID-19 caused by SARS-CoV-2.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Terminated (halted prematurely)&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 15, 2020</start_date>
  <completion_date type="Anticipated">December 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 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>
    <intervention_model_description>This is a two phase study. The first 10 subjects will be treated with 80ppm NO; The remaining 40 subjects will be randomized in 1:1 ratio with subjects receiving 150 NO+SST or the SST alone.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to deterioration</measure>
    <time_frame>up to 14 days</time_frame>
    <description>Time to deterioration as measured by any one of the following:&#xD;
need for non-invasive ventilation&#xD;
need for high flow nasal cannula (HFNC) or&#xD;
need for intubation&#xD;
Death from any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to stable oxygen saturation</measure>
    <time_frame>up to 14 days</time_frame>
    <description>Time to patient having stable oxygen saturation (SpO2) of greater than 92% for longer than 3 hr on room air</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Treatment Emergent Adverse Events and SAEs</measure>
    <time_frame>30 days after last inhalation treatment</time_frame>
    <description>Treatment Emergent Adverse Events and SAEs - safety evaluation for 30 days after last inhalation treatment</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID-19</condition>
  <condition>SARS-CoV 2</condition>
  <condition>Respiratory Disease</condition>
  <condition>Pneumonia, Viral</condition>
  <condition>Corona Virus Infection</condition>
  <arm_group>
    <arm_group_label>Phase 1- Nitric oxide treatment- 80ppm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2- Group 1- Nitric oxide treatment- 150ppm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2- Group 2- control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of Care</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>150 ppm Nitric Oxide delivered through LungFit Delivery System</intervention_name>
    <description>Nitric Oxide delivered via LungFit system. Patients will receive inhalations of 150 ppm for 40 minutes 4 time per day plus standard supportive care.</description>
    <arm_group_label>Phase 2- Group 1- Nitric oxide treatment- 150ppm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>80 ppm Nitric Oxide delivered through LungFit Delivery System</intervention_name>
    <description>Nitric Oxide delivered via LungFit system. Patients will receive inhalations of 80 ppm for 40 minutes 4 time per day plus standard supportive care.</description>
    <arm_group_label>Phase 1- Nitric oxide treatment- 80ppm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients (male and female) admitted to the hospital for COVID-19&#xD;
&#xD;
          2. Patients with oxygen saturation less than 93 % on room air&#xD;
&#xD;
          3. Shortness of breath, with symptom onset within the previous 8 days.&#xD;
&#xD;
          4. Ability to understand and comply with study requirements .&#xD;
&#xD;
          5. Signed informed consent by subject&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who are treated with or require high flow nasal cannula, CPAP, intubation,&#xD;
             mechanical ventilation, or tracheostomy&#xD;
&#xD;
          2. Diagnosis of acute respiratory distress syndrome&#xD;
&#xD;
          3. Breastfeeding or pregnancy as evidenced by a positive pregnancy test.&#xD;
&#xD;
          4. Subjects diagnosed with immunodeficiency, with history of congestive or unstable heart&#xD;
             disease, left ventricular dysfunction (LVEF &lt;40%) or myocardial damage, severe&#xD;
             pulmonary hypertension and/or unstable hypertension&#xD;
&#xD;
          5. History of frequent epistaxis (&gt;1 episode/month).&#xD;
&#xD;
          6. Significant hemoptysis during the last 30 days prior to enrollment&#xD;
&#xD;
          7. Methemoglobin level &gt;3% at screening&#xD;
&#xD;
          8. Patients on systemic steroids (any formulation) within 30 days prior to enrollment.&#xD;
&#xD;
          9. History of daily, continuous oxygen supplementation&#xD;
&#xD;
         10. Patients with BMI greater than or equal to 36&#xD;
&#xD;
         11. Patient receiving drugs that have a contraindication with NO,&#xD;
&#xD;
         12. Patients with clinically significant anemia, e.g., Hb &lt;100 g/L and thrombocytopenia,&#xD;
             e.g., Platelets &lt;75 thousand cells/mcL.&#xD;
&#xD;
         13. Presence of a condition or abnormality that in the opinion of the Investigator would&#xD;
             compromise the safety of the subject or the quality of the data, e.g., known or&#xD;
             suspected thalassemia, sickle cell disease or other diseases associated with poor&#xD;
             oxygen carrying capacity.&#xD;
&#xD;
         14. The subject is identified by the investigator as being unable or unwilling to perform&#xD;
             study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Asher Tal, MD</last_name>
    <role>Study Director</role>
    <affiliation>Beyond Air</affiliation>
  </overall_official>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>January 21, 2021</last_update_submitted>
  <last_update_submitted_qc>January 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Pneumonia, Viral</mesh_term>
    <mesh_term>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nitric Oxide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04456088
org study id: BAI_COV19_01_CAN
nct id: NCT04456088
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this open label, 2-phase, study is to obtain information on the safety of 80
      ppm and the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of
      care of patients with COVID-19 caused by SARS-CoV-2.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a two phase study. The first 10 subjects will be treated with 80ppm NO; The remaining 40 subjects will be randomized in 1:1 ratio with subjects receiving 150 NO+SST or the SST alone.
primary purpose: Treatment
masking: None (Open Label)
measure: Time to deterioration
time frame: up to 14 days
description: Time to deterioration as measured by any one of the following:
need for non-invasive ventilation
need for high flow nasal cannula (HFNC) or
need for intubation
Death from any cause
measure: Time to stable oxygen saturation
time frame: up to 14 days
description: Time to patient having stable oxygen saturation (SpO2) of greater than 92% for longer than 3 hr on room air
measure: Treatment Emergent Adverse Events and SAEs
time frame: 30 days after last inhalation treatment
description: Treatment Emergent Adverse Events and SAEs - safety evaluation for 30 days after last inhalation treatment
arm group label: Phase 1- Nitric oxide treatment- 80ppm
arm group type: Experimental
arm group label: Phase 2- Group 1- Nitric oxide treatment- 150ppm
arm group type: Experimental
arm group label: Phase 2- Group 2- control
arm group type: No Intervention
description: Standard of Care
intervention type: Combination Product
intervention name: 150 ppm Nitric Oxide delivered through LungFit Delivery System
description: Nitric Oxide delivered via LungFit system. Patients will receive inhalations of 150 ppm for 40 minutes 4 time per day plus standard supportive care.
arm group label: Phase 2- Group 1- Nitric oxide treatment- 150ppm
intervention type: Combination Product
intervention name: 80 ppm Nitric Oxide delivered through LungFit Delivery System
description: Nitric Oxide delivered via LungFit system. Patients will receive inhalations of 80 ppm for 40 minutes 4 time per day plus standard supportive care.
arm group label: Phase 1- Nitric oxide treatment- 80ppm
criteria: 
gender: All
minimum age: 22 Years
maximum age: 75 Years
healthy volunteers: No
last name: Asher Tal, MD
role: Study Director
affiliation: Beyond Air
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Pneumonia, Viral
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
mesh term: Nitric Oxide
sharing ipd: No