<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/NCT04429555</url>
  </required_header>
  <id_info>
    <org_study_id>MN-166-COVID-19-201</org_study_id>
    <nct_id>NCT04429555</nct_id>
  </id_info>
  <brief_title>Efficacy, Safety, Tolerability, and Biomarkers of MN-166 (Ibudilast) in Patients Hospitalized With COVID-19 and at Risk for ARDS</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, Tolerability, Biomarkers and Pharmacokinetics of Ibudilast (MN-166) in COVID-19 Subjects at Risk for Developing Acute Respiratory Distress Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MediciNova</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MediciNova</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 study aims to evaluate MN-166 (ibudilast) in patients with COVID-19 who are at risk of&#xD;
      developing acute respiratory distress syndrome. Subjects will be screened, randomly assigned&#xD;
      to MN-166 or placebo groups, receive study drug on Days 1-7, and followed up on Day 14 and&#xD;
      Day 28.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized (1:1) double-blind, placebo-controlled, parallel-group study of&#xD;
      ibudilast in hospitalized COVID-19 subjects at risk for developing ARDS receiving standard of&#xD;
      care including anticoagulation. The study will consist of a Screening Phase followed by a&#xD;
      Treatment and Follow-up Phase. Following the Screening Phase, if the subject meets&#xD;
      eligibility criteria, subject will be administered treatment with MN-166 (ibudilast) or&#xD;
      placebo. Subjects will receive ibudilast 100 mg/d (50 mg b.i.d) or placebo every day for 7&#xD;
      days. Upon completion of the 7-day Treatment Phase, subject will be followed-up at Day 14 and&#xD;
      at Day 28 post baseline. Subjects discharged prior to Day 7 will be given the remainder of&#xD;
      their study medication to be taken at home twice daily and will be given a pulse oximeter to&#xD;
      measure their oxygen levels once daily until Day 14.&#xD;
&#xD;
      The following screening assessments will be performed upon signing the ICF:&#xD;
      inclusion/exclusion criteria review, physical exam, assess vital signs and O2 use, clinical&#xD;
      status using the National Institute of Allergy and Infectious Diseases scale, 12-lead ECG,&#xD;
      draw blood for plasma biomarkers that include: migration inhibitory factor (MIF),&#xD;
      (interleukin 1-beta (IL-1β), interleukin 6 (IL-6), tumor necrosis factor (TNFα), and&#xD;
      C-reactive protein (CRP). A complete blood count (CBC), comprehensive metabolic panel (CMP),&#xD;
      D-dimer and coagulation tests will also be drawn. A serum pregnancy test will be done in&#xD;
      pre-menopausal females. Prior concomitant medications taken within the last 7 days prior to&#xD;
      study drug administration will be recorded.&#xD;
&#xD;
      During the Treatment Phase, hospitalized subjects will be treated with MN-166 or placebo for&#xD;
      a 7-day period. During the Treatment Phase, subjects will undergo study-related procedures&#xD;
      including physical exam, ECG, Oxygen use assessment, biomarkers and pharmacokinetic samples&#xD;
      draw, CBC, CMP, D-dimer blood collection, clinical assessment using the NIAID scale, and&#xD;
      information on adverse events and concomitant medications will be recorded.&#xD;
&#xD;
      On Study Day 14, conduct physical examination, clinical status, vital signs and oxygen use,&#xD;
      ECG, CBC, CMP, D-dimer, and coagulation tests, biomarkers, AE and concomitant medications&#xD;
      review. On Day 28, subject's clinical status and survival status will be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 11, 2021</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Randomized, double-blind, placebo-controlled, parallel-group study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects free from respiratory failure at Day 7</measure>
    <time_frame>Day 7</time_frame>
    <description>Proportion of subjects free from respiratory failure as defined by the need for decreased oxygen requirements (invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or ECMO, CPAP, BiPAP, nasal cannula) at Day 7. The scale is as follows: 1 = Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 5=Hospitalized, Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8=Death.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of subjects with at least a 1-point improvement in clinical status using the National Institute on Allergy and Infectious Disease 8-point ordinal scale and discharge record at Day 7</measure>
    <time_frame>Day 7</time_frame>
    <description>Percentage of subjects who improved at least by 1 point in the National Institute of Allergy and Infectious Diseases 8-point scale and discharge record at Day 7. The scale is as follows: 1 = Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 5=Hospitalized, Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8=Death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse event incidence and severity</measure>
    <time_frame>Days 7, 14, 28 and 60 (Day 60 applies to intubated subjects only)</time_frame>
    <description>Incidence, frequency, and severity of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects free from respiratory failure as defined by the need for decreased oxygen requirement (invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or ECMO, CPAP, BiPAP, nasal cannula) at Days 14, 28, and 60</measure>
    <time_frame>Days 14, 28, and 60 (Day 60 applies to intubated subjects only)</time_frame>
    <description>Proportion of subjects free from respiratory failure as defined by the need for decreased oxygen requirement (invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or ECMO, CPAP, BiPAP, nasal cannula) at Days 14, 28, and 60 (Day 60 applies to intubated subjects only). The scale is as follows: 1 = Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 5=Hospitalized, Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8=Death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline in clinical status at Days 7, 14, 28, and 60</measure>
    <time_frame>Days 7, 14, 28, and 60 (Day 60 applies to intubated subjects only)</time_frame>
    <description>Mean change from baseline in clinical status at Days 7,14, 28, and 60 using the National Institute on Allergy and Infectious Disease 8-point ordinal scale and discharge record at Days 7, 14, 28, and 60 (Day 60 applies to intubated subjects only). The scale is as follows: 1 = Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 5=Hospitalized, Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8=Death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of mechanical ventilation or intubation at Day 7, 14, 28, and 60</measure>
    <time_frame>Days 7, 14, 28, and 60 (Day 60 applies to intubated subjects only)</time_frame>
    <description>Proportion of subjects receiving mechanical ventilation or intubation at Days 7, 14, 28, and 60</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with at least a 1-point improvement in clinical status at Days 14, 28, and 60</measure>
    <time_frame>Days 14, 28, and 60 (Day 60 applies to intubated subjects only)</time_frame>
    <description>Proportion of subjects with at least a 1-point improvement in clinical status at Days 14, 28, and 60 using the National Institute on Allergy and Infectious Disease 8-point ordinal scale and discharge record at Days 7, 14, and 60. The scale is as follows: 1 = Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 5=Hospitalized, Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8=Death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality at Days 7,14, 28, and 60</measure>
    <time_frame>Days 7, 14, 28, and 60 (Day 60 applies to intubated subjects only)</time_frame>
    <description>Number of deaths from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects discharged from hospital at Days 7,14, 28, and 60</measure>
    <time_frame>Days 7, 14, 28, and 60</time_frame>
    <description>Proportion of subjects discharged from hospital at Days 7,14, 28, and 60 (Day 60 applies to intubated subjects only)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Pneumonia, Viral</condition>
  <arm_group>
    <arm_group_label>MN-166 (ibudilast)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MN-166 capsules, 50 mg twice daily, for 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsules, 50 mg twice daily, for 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibudilast</intervention_name>
    <description>Ibudilast orally administered, 50 mg twice daily for 7 days.</description>
    <arm_group_label>MN-166 (ibudilast)</arm_group_label>
    <other_name>MN-166</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo orally administered, 50 mg twice daily for 7 days.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  SARS-CoV-2 infection confirmed with WHO criteria (including a positive PCR of any&#xD;
             specimen, e.g., blood, respiratory, stool, urine, or any other body fluid)&#xD;
&#xD;
          -  Chest imaging (radiograph, CT scan or lung ultrasound) with abnormalities consistent&#xD;
             with COVID-19 pneumonia&#xD;
&#xD;
          -  SpO2 ≤ 92% on room air (RA), RR ≥24 breaths per min on RA, and/or requirement for&#xD;
             supplemental oxygen&#xD;
&#xD;
          -  At least 1 risk factor which may put patient at higher risk for more severe illness&#xD;
             from COVID-19: Age &gt; 65, underlying serious heart disease, chronic lung disease,&#xD;
             moderate to severe asthma, body mass index of ≥ 40 or diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspected active bacterial, fungal, viral, or other cause of respiratory failure other&#xD;
             than COVID-19&#xD;
&#xD;
          -  Subject is already intubated and on ventilator support&#xD;
&#xD;
          -  Known or suspected immunosuppression with immunosuppressant medications or&#xD;
             chemotherapeutic agents&#xD;
&#xD;
          -  Subject is on dialysis&#xD;
&#xD;
          -  On home ventilator support or continuous domiciliary O2 therapy for baseline lung&#xD;
             disease&#xD;
&#xD;
          -  Active tuberculosis (TB) infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kazuko Matsuda, MD PhD MPH</last_name>
    <role>Study Chair</role>
    <affiliation>Medicinova Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Denver Health and Hospital Authority</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>May 25, 2023</last_update_submitted>
  <last_update_submitted_qc>May 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2023</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>Pneumonia</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>Pneumonia, Viral</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>Ibudilast</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/NCT04429555
org study id: MN-166-COVID-19-201
nct id: NCT04429555
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The study aims to evaluate MN-166 (ibudilast) in patients with COVID-19 who are at risk of
      developing acute respiratory distress syndrome. Subjects will be screened, randomly assigned
      to MN-166 or placebo groups, receive study drug on Days 1-7, and followed up on Day 14 and
      Day 28.
This is a randomized (1:1) double-blind, placebo-controlled, parallel-group study of
      ibudilast in hospitalized COVID-19 subjects at risk for developing ARDS receiving standard of
      care including anticoagulation. The study will consist of a Screening Phase followed by a
      Treatment and Follow-up Phase. Following the Screening Phase, if the subject meets
      eligibility criteria, subject will be administered treatment with MN-166 (ibudilast) or
      placebo. Subjects will receive ibudilast 100 mg/d (50 mg b.i.d) or placebo every day for 7
      days. Upon completion of the 7-day Treatment Phase, subject will be followed-up at Day 14 and
      at Day 28 post baseline. Subjects discharged prior to Day 7 will be given the remainder of
      their study medication to be taken at home twice daily and will be given a pulse oximeter to
      measure their oxygen levels once daily until Day 14.

      The following screening assessments will be performed upon signing the ICF:
      inclusion/exclusion criteria review, physical exam, assess vital signs and O2 use, clinical
      status using the National Institute of Allergy and Infectious Diseases scale, 12-lead ECG,
      draw blood for plasma biomarkers that include: migration inhibitory factor (MIF),
      (interleukin 1-beta (IL-1β), interleukin 6 (IL-6), tumor necrosis factor (TNFα), and
      C-reactive protein (CRP). A complete blood count (CBC), comprehensive metabolic panel (CMP),
      D-dimer and coagulation tests will also be drawn. A serum pregnancy test will be done in
      pre-menopausal females. Prior concomitant medications taken within the last 7 days prior to
      study drug administration will be recorded.

      During the Treatment Phase, hospitalized subjects will be treated with MN-166 or placebo for
      a 7-day period. During the Treatment Phase, subjects will undergo study-related procedures
      including physical exam, ECG, Oxygen use assessment, biomarkers and pharmacokinetic samples
      draw, CBC, CMP, D-dimer blood collection, clinical assessment using the NIAID scale, and
      information on adverse events and concomitant medications will be recorded.

      On Study Day 14, conduct physical examination, clinical status, vital signs and oxygen use,
      ECG, CBC, CMP, D-dimer, and coagulation tests, biomarkers, AE and concomitant medications
      review. On Day 28, subject's clinical status and survival status will be recorded.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, double-blind, placebo-controlled, parallel-group study.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Proportion of subjects free from respiratory failure at Day 7
time frame: Day 7
description: Proportion of subjects free from respiratory failure as defined by the need for decreased oxygen requirements (invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or ECMO, CPAP, BiPAP, nasal cannula) at Day 7. The scale is as follows: 1 = Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 5=Hospitalized, Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8=Death.
measure: Proportion of subjects with at least a 1-point improvement in clinical status using the National Institute on Allergy and Infectious Disease 8-point ordinal scale and discharge record at Day 7
time frame: Day 7
description: Percentage of subjects who improved at least by 1 point in the National Institute of Allergy and Infectious Diseases 8-point scale and discharge record at Day 7. The scale is as follows: 1 = Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 5=Hospitalized, Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8=Death.
measure: Adverse event incidence and severity
time frame: Days 7, 14, 28 and 60 (Day 60 applies to intubated subjects only)
description: Incidence, frequency, and severity of adverse events
measure: Proportion of subjects free from respiratory failure as defined by the need for decreased oxygen requirement (invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or ECMO, CPAP, BiPAP, nasal cannula) at Days 14, 28, and 60
time frame: Days 14, 28, and 60 (Day 60 applies to intubated subjects only)
description: Proportion of subjects free from respiratory failure as defined by the need for decreased oxygen requirement (invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or ECMO, CPAP, BiPAP, nasal cannula) at Days 14, 28, and 60 (Day 60 applies to intubated subjects only). The scale is as follows: 1 = Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 5=Hospitalized, Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8=Death.
measure: Mean change from baseline in clinical status at Days 7, 14, 28, and 60
time frame: Days 7, 14, 28, and 60 (Day 60 applies to intubated subjects only)
description: Mean change from baseline in clinical status at Days 7,14, 28, and 60 using the National Institute on Allergy and Infectious Disease 8-point ordinal scale and discharge record at Days 7, 14, 28, and 60 (Day 60 applies to intubated subjects only). The scale is as follows: 1 = Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 5=Hospitalized, Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8=Death.
measure: Incidence of mechanical ventilation or intubation at Day 7, 14, 28, and 60
time frame: Days 7, 14, 28, and 60 (Day 60 applies to intubated subjects only)
description: Proportion of subjects receiving mechanical ventilation or intubation at Days 7, 14, 28, and 60
measure: Proportion of subjects with at least a 1-point improvement in clinical status at Days 14, 28, and 60
time frame: Days 14, 28, and 60 (Day 60 applies to intubated subjects only)
description: Proportion of subjects with at least a 1-point improvement in clinical status at Days 14, 28, and 60 using the National Institute on Allergy and Infectious Disease 8-point ordinal scale and discharge record at Days 7, 14, and 60. The scale is as follows: 1 = Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 5=Hospitalized, Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8=Death.
measure: All-cause mortality at Days 7,14, 28, and 60
time frame: Days 7, 14, 28, and 60 (Day 60 applies to intubated subjects only)
description: Number of deaths from any cause
measure: Proportion of subjects discharged from hospital at Days 7,14, 28, and 60
time frame: Days 7, 14, 28, and 60
description: Proportion of subjects discharged from hospital at Days 7,14, 28, and 60 (Day 60 applies to intubated subjects only)
arm group label: MN-166 (ibudilast)
arm group type: Experimental
description: MN-166 capsules, 50 mg twice daily, for 7 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo capsules, 50 mg twice daily, for 7 days.
intervention type: Drug
intervention name: Ibudilast
description: Ibudilast orally administered, 50 mg twice daily for 7 days.
arm group label: MN-166 (ibudilast)
other name: MN-166
intervention type: Drug
intervention name: Placebo
description: Placebo orally administered, 50 mg twice daily for 7 days.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kazuko Matsuda, MD PhD MPH
role: Study Chair
affiliation: Medicinova Inc
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Pneumonia, Viral
mesh term: Respiratory Distress Syndrome
mesh term: Ibudilast