<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/NCT03808922</url>
  </required_header>
  <id_info>
    <org_study_id>DAS181-3-01</org_study_id>
    <secondary_id>2018-004318-16</secondary_id>
    <nct_id>NCT03808922</nct_id>
  </id_info>
  <brief_title>Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study</brief_title>
  <official_title>A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ansun Biopharma, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ansun Biopharma, 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 study will seek to enroll immunocompromised patients with Lower Tract parainfluenza&#xD;
      infection.&#xD;
&#xD;
      It also contains a sub-study to enroll patients with severe COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible subjects (i.e., those meeting the Inclusion / Exclusion criteria) will be enrolled&#xD;
      in one of four cohorts based on the following criteria:&#xD;
&#xD;
      Cohort 1:&#xD;
&#xD;
      All eligible subjects in the PoI who are ≥18 year old subjects with a PIV infection and meet&#xD;
      all of the following criteria:&#xD;
&#xD;
      1.1 Meet criteria for being severely immunocompromised 1.2 Prior to the onset of PIV&#xD;
      infection, had no ongoing need for oxygen therapy due to a chronic respiratory condition&#xD;
      (e.g., COPD, sleep apnea) and are assessed as acutely hypoxemic due to their PIV infection&#xD;
      1.3 At the time of randomization are not on mechanical, bi-level or continuous positive&#xD;
      airway pressure (Bi-PAP or CPAP) ventilation 1.4 Have no known concurrent respiratory viral&#xD;
      coinfection(s)&#xD;
&#xD;
      Cohort 2:&#xD;
&#xD;
      All eligible subjects in the PoI who are ≥18 year old with a PIV infection (including those&#xD;
      with PIV and another SAD-RV) who do not meet one or more of the listed criteria for Cohort 1.&#xD;
&#xD;
      Cohort 3:&#xD;
&#xD;
      All eligible subjects in the PoI who are &lt;18 year old subjects with a PIV infection&#xD;
      (including those with PIV and another concurrent SAD-RV). There is no lower age limit for&#xD;
      this cohort.&#xD;
&#xD;
      Cohort 4:&#xD;
&#xD;
      All eligible subjects in the PoI with a respiratory infection due to any SAD-RV infection&#xD;
      except PIV. Eligible subjects with both PIV and an additional concurrent SAD-RV, will be&#xD;
      enrolled for either Cohorts 2 or 3 depending on their age. There is no lower age limit for&#xD;
      this cohort.&#xD;
&#xD;
      Sub-Study:&#xD;
&#xD;
      Patients with Severe COVID-19&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 23, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <phase>Phase 3</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>Percent of subjects who Return to Room Air (RTRA) (main study)</measure>
    <time_frame>by Day 28</time_frame>
    <description>Removal of all oxygen support (with stable SpO2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)</measure>
    <time_frame>Day 14</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality rate (main study)</measure>
    <time_frame>at Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of subjects who Return to Room Air (RTRA) (main study)</measure>
    <time_frame>by Day 21</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time (in days) to RTRA (main study)</measure>
    <time_frame>Days 10, 14, 21, 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of subjects who achieve clinical stability (main study)</measure>
    <time_frame>by Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of subjects discharged (without mortality and hospice) (main study)</measure>
    <time_frame>by Days 14, 21, 28 and 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time (in days) to first hospital discharge (without hospice) (main study)</measure>
    <time_frame>through Day 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of inpatient days (main study)</measure>
    <time_frame>up to Day 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline SAD-RV infection-related mortality rate (main study)</measure>
    <time_frame>at Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline SAD-RV infection-related mortality rate (main study)</measure>
    <time_frame>at Day 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality rate (main study)</measure>
    <time_frame>at Day 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pulmonary function (FEV1% predicted) (main study)</measure>
    <time_frame>Day 1, Day 7, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to improved COVID19 clinical status (Sub-study)</measure>
    <time_frame>Day 5, Day 10, Day 21, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to RTRA</measure>
    <time_frame>Day 10, Day 14, Day 21, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Clinical stability</measure>
    <time_frame>Day 14, Day 21, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to SARS-CoV-2 RNA in the respiratory specimens being undetectable</measure>
    <time_frame>Day 5, Day 10, Day 14, Day 21, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Clinical deterioration</measure>
    <time_frame>Day 5, Day 10, Day 14, Day 21, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Discharge from hospital (without readmission before Day 28).</measure>
    <time_frame>Day 14, Day 21, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Death (all causes)</measure>
    <time_frame>Day 14, Day 21, Day 28</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">274</enrollment>
  <condition>Lower Respiratory Tract Infection</condition>
  <condition>Parainfluenza</condition>
  <condition>Immunocompromised</condition>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Cohort 1 and Cohort 2 Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DAS181 4.5mg qd x 7 OR 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1 and Cohort 2 Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo qd x 7 OR 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DAS181 4.5mg qd x 7 OR 10 days (≥ 40 kg) DAS181 2.5mg qd x 7 OR 10 days (&lt; 40kg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DAS181 4.5mg qd x 7 OR 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DAS181 COVID-19 Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DAS181 4.5mg q12h x 7 OR 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DAS181 COVID-19 Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo q12h x 7 OR 10 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DAS181</intervention_name>
    <description>DAS181 4.5mg nebulized qd x 7 OR 10 days</description>
    <arm_group_label>Cohort 1 and Cohort 2 Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo nebulized qd x 7 OR 10 days</description>
    <arm_group_label>Cohort 1 and Cohort 2 Placebo</arm_group_label>
    <arm_group_label>DAS181 COVID-19 Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DAS181 COVID-19</intervention_name>
    <description>DAS181 4.5mg nebulized q12h/day x 7 OR 10 days</description>
    <arm_group_label>DAS181 COVID-19 Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DAS181 OL</intervention_name>
    <description>DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days &lt; 40kg</description>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_label>Cohort 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. At the time of randomization, requires supplemental oxygen ≥2 LPM due to hypoxemia.&#xD;
&#xD;
          2. Immunocompromised, as defined by one or more of the following:&#xD;
&#xD;
               -  Received an autologous or allogeneic hematopoietic stem cell transplantation&#xD;
                  (HSCT) at any time in the past&#xD;
&#xD;
               -  Received a solid organ transplant at any time in the past&#xD;
&#xD;
               -  Has been or is currently being treated with chemotherapy for hematologic&#xD;
                  malignancies (e.g., leukemia, myeloma, lymphoma) and/or solid tumor malignancies&#xD;
                  (e.g., lung, breast, brain cancer) at any time in the past&#xD;
&#xD;
               -  Has an immunodeficiency due to congenital abnormality (only applicable to&#xD;
                  subjects age &lt; 18 years old) or pre-term birth (only applicable to subjects age ≤&#xD;
                  2 years old)&#xD;
&#xD;
          3. Has, within 3 days prior to randomization, a confirmed LRTI with a sialic acid&#xD;
             dependent respiratory virus&#xD;
&#xD;
          4. If female, subject must meet one of the following conditions:&#xD;
&#xD;
               -  Not be of childbearing potential or&#xD;
&#xD;
               -  Be of childbearing potential and have a negative urine/serum pregnancy test and&#xD;
                  agrees to practice an acceptable method of contraception&#xD;
&#xD;
          5. Non-vasectomized males are required to practice effective birth control methods&#xD;
&#xD;
          6. Capable of understanding and complying with procedures as outlined in the protocol&#xD;
&#xD;
          7. Provides signed informed consent prior to the initiation of any screening or&#xD;
             study-specific procedures&#xD;
&#xD;
        For COVID-19 sub study:&#xD;
&#xD;
          1. Be ≥18 years of age&#xD;
&#xD;
          2. Provide adequate medical history to permit accurate stratification (but health status&#xD;
             may be healthy, high-risk conditions, or immunocompromised).&#xD;
&#xD;
          3. Prior to SARS CoV 2 infection, has the ability to carry out self-care activities of&#xD;
             daily living (basic ADL)&#xD;
&#xD;
          4. Have lower respiratory tract infection (LRTI) confirmed by CT imaging, with or without&#xD;
             contrast, to involve at least 2 lobes of the lung.&#xD;
&#xD;
          5. Has laboratory-confirmation of the presence of SARS CoV 2 in the respiratory tract by&#xD;
             at least one of the following samples&#xD;
&#xD;
          6. Satisfy inclusion criteria #1, 4, 5, 6, 7 of the main study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects may not be on hospice care or, in the opinion of the investigator, have a low&#xD;
             chance of survival during the first 10 days of treatment&#xD;
&#xD;
          2. Subjects with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or&#xD;
             Alkaline Phosphatase (ALP) ≥3x ULN and Total Bilirubin (TBILI) ≥2x ULN Note: Subjects&#xD;
             with ALT/AST/ALP ≥ 3x ULN AND TB ≥2x ULN that have been chronically stable (for &gt;1&#xD;
             year on more than one assessments) due to known liver pathology including malignancy&#xD;
             (primary or metastasis), chronic medications, transplantation, or chronic infection&#xD;
             will not be excluded&#xD;
&#xD;
          3. Female subjects breastfeeding or planning to breastfeed at any time through 30 days&#xD;
             after the last dose of study drug&#xD;
&#xD;
          4. Subjects taking any other investigational drug used to treat pulmonary infection.&#xD;
&#xD;
          5. Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion&#xD;
             of the principal investigator, would affect subject safety and/or compliance&#xD;
&#xD;
          6. Subjects with known hypersensitivity to DAS181 and/or any of its components&#xD;
&#xD;
          7. Subjects with severe sepsis due to either their baseline SAD-RV infection or a&#xD;
             concurrent viral, bacterial, or fungal infection and meet at least one of the&#xD;
             following criteria:&#xD;
&#xD;
               -  Has evidence of vital organ failure outside of the lung (e.g., liver, kidney)&#xD;
&#xD;
               -  Requires vasopressors to maintain blood pressure&#xD;
&#xD;
        For COVID-19 sub study:&#xD;
&#xD;
          1. Subjects requiring invasive mechanical, Bi-PAP or CPAP ventilation at randomization.&#xD;
&#xD;
          2. Subjects receiving any other investigational or empiric treatment for SARS-2-CoV&#xD;
             (either as part of a clinical trial or under emergency approval (approved agents for&#xD;
             the management of symptoms, e.g., fever, are permitted).&#xD;
&#xD;
          3. Subjects who are known HIV-positive (and not undetectable at most recent HIV RNA&#xD;
             assessment)&#xD;
&#xD;
          4. Subjects who are currently taking immunomodulating biologics (e.g, interferons,&#xD;
             interleukin)&#xD;
&#xD;
          5. Subjects with severe sepsis due to either their SARS-CoV-2 infection or a concurrent&#xD;
             viral, bacterial, or fungal infection and meeting at least one of the following&#xD;
             criteria:&#xD;
&#xD;
               -  Have evidence of vital organ failure outside of the lung (e.g., liver, kidney)&#xD;
&#xD;
               -  Require vasopressors to maintain blood pressure&#xD;
&#xD;
          6. Subjects meeting exclusion criteria #2, 3, 5 and 6 of the main study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>George Wang</last_name>
    <role>Study Director</role>
    <affiliation>Ansun Biopharma, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lisa Li</last_name>
    <phone>858-353-4948</phone>
    <email>lli@ansunbiopharma.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Danielle Slemons</last_name>
    <email>dslemons@ansunbiopharma.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>City of Hope cancer Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of California Davis Health System</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stuart Cohen, MD</last_name>
    </contact>
    <investigator>
      <last_name>Stuart Cohen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of California San Diego Medical Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Fairway</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Louisiana State University</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shmuel Shoham, MD</last_name>
    </contact>
    <investigator>
      <last_name>Shmuel Shoham, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Universtiy of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kevin Gregg, MD</last_name>
    </contact>
    <investigator>
      <last_name>Kevin Gregg, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yeon Joo Lee, MD</last_name>
    </contact>
    <investigator>
      <last_name>Yeon Joo Lee, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rosypriya Kodiyanplakkal, MD</last_name>
    </contact>
    <investigator>
      <last_name>Rosypriya Kodiyanplakkal, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cameron Wolfe, MD</last_name>
    </contact>
    <investigator>
      <last_name>Cameron Wolfe, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Novant Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Lindner Center- The Christ Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>St. Elizabeth Youngstown Hospital</name>
      <address>
        <city>Youngstown</city>
        <state>Ohio</state>
        <zip>44501</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center Health System</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kent Hospital</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Cook Children's</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Texas Health</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Therapeutic Concepts</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>MD Anderson</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>VCU Health System</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristin Miller, MD</last_name>
    </contact>
    <investigator>
      <last_name>Kristin Miller, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Froedtert Medical College Pulmonary Clinic</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53266</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jonathon Truwit, MD</last_name>
    </contact>
    <investigator>
      <last_name>Jonathon Truwit, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>The Wesley Hospital</name>
      <address>
        <city>Auchenflower</city>
        <state>Queensland</state>
        <zip>4066</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Peter MacCallum Cancer Centre</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Shanghai Pulmonary Hospital</name>
      <address>
        <city>Yangpu</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>West China Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Shulan (Hangzhou) Hospital co., LTD</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Hôpital Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <state>Ile-de-France</state>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Sha Tin</city>
        <state>New Territories</state>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Gyeonggi-do</state>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Gyeonggi-do</state>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Gyeonggi-do</state>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Gyeonggi-do</state>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Zhongzheng</city>
        <state>Taipei City</state>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>China</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Hong Kong</country>
    <country>Korea, Republic of</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parainfluenza</keyword>
  <keyword>PIV</keyword>
  <keyword>Immunocompromised</keyword>
  <keyword>Lower Respiratory Tract Infection</keyword>
  <keyword>LRTI</keyword>
  <keyword>COVID19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Coronavirus</keyword>
  <keyword>Ansun</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Paramyxoviridae Infections</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/NCT03808922
org study id: DAS181-3-01
secondary id: 2018-004318-16
nct id: NCT03808922
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza
      infection.

      It also contains a sub-study to enroll patients with severe COVID-19.
Eligible subjects (i.e., those meeting the Inclusion / Exclusion criteria) will be enrolled
      in one of four cohorts based on the following criteria:

      Cohort 1:

      All eligible subjects in the PoI who are ≥18 year old subjects with a PIV infection and meet
      all of the following criteria:

      1.1 Meet criteria for being severely immunocompromised 1.2 Prior to the onset of PIV
      infection, had no ongoing need for oxygen therapy due to a chronic respiratory condition
      (e.g., COPD, sleep apnea) and are assessed as acutely hypoxemic due to their PIV infection
      1.3 At the time of randomization are not on mechanical, bi-level or continuous positive
      airway pressure (Bi-PAP or CPAP) ventilation 1.4 Have no known concurrent respiratory viral
      coinfection(s)

      Cohort 2:

      All eligible subjects in the PoI who are ≥18 year old with a PIV infection (including those
      with PIV and another SAD-RV) who do not meet one or more of the listed criteria for Cohort 1.

      Cohort 3:

      All eligible subjects in the PoI who are <18 year old subjects with a PIV infection
      (including those with PIV and another concurrent SAD-RV). There is no lower age limit for
      this cohort.

      Cohort 4:

      All eligible subjects in the PoI with a respiratory infection due to any SAD-RV infection
      except PIV. Eligible subjects with both PIV and an additional concurrent SAD-RV, will be
      enrolled for either Cohorts 2 or 3 depending on their age. There is no lower age limit for
      this cohort.

      Sub-Study:

      Patients with Severe COVID-19
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percent of subjects who Return to Room Air (RTRA) (main study)
time frame: by Day 28
description: Removal of all oxygen support (with stable SpO2)
measure: Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)
time frame: Day 14
measure: All-cause mortality rate (main study)
time frame: at Day 28
measure: Percent of subjects who Return to Room Air (RTRA) (main study)
time frame: by Day 21
measure: Time (in days) to RTRA (main study)
time frame: Days 10, 14, 21, 28
measure: Percent of subjects who achieve clinical stability (main study)
time frame: by Day 28
measure: Percent of subjects discharged (without mortality and hospice) (main study)
time frame: by Days 14, 21, 28 and 35
measure: Time (in days) to first hospital discharge (without hospice) (main study)
time frame: through Day 35
measure: Total number of inpatient days (main study)
time frame: up to Day 35
measure: Baseline SAD-RV infection-related mortality rate (main study)
time frame: at Day 28
measure: Baseline SAD-RV infection-related mortality rate (main study)
time frame: at Day 35
measure: All-cause mortality rate (main study)
time frame: at Day 35
measure: Change in pulmonary function (FEV1% predicted) (main study)
time frame: Day 1, Day 7, Day 14, Day 28
measure: Time to improved COVID19 clinical status (Sub-study)
time frame: Day 5, Day 10, Day 21, Day 28
measure: Time to RTRA
time frame: Day 10, Day 14, Day 21, Day 28
measure: Time to Clinical stability
time frame: Day 14, Day 21, Day 28
measure: Time to SARS-CoV-2 RNA in the respiratory specimens being undetectable
time frame: Day 5, Day 10, Day 14, Day 21, Day 28
measure: Time to Clinical deterioration
time frame: Day 5, Day 10, Day 14, Day 21, Day 28
measure: Time to Discharge from hospital (without readmission before Day 28).
time frame: Day 14, Day 21, Day 28
measure: Time to Death (all causes)
time frame: Day 14, Day 21, Day 28
arm group label: Cohort 1 and Cohort 2 Treatment
arm group type: Experimental
description: DAS181 4.5mg qd x 7 OR 10 days
arm group label: Cohort 1 and Cohort 2 Placebo
arm group type: Placebo Comparator
description: Placebo qd x 7 OR 10 days
arm group label: Cohort 3
arm group type: Experimental
description: DAS181 4.5mg qd x 7 OR 10 days (≥ 40 kg) DAS181 2.5mg qd x 7 OR 10 days (< 40kg)
arm group label: Cohort 4
arm group type: Experimental
description: DAS181 4.5mg qd x 7 OR 10 days
arm group label: DAS181 COVID-19 Treatment
arm group type: Experimental
description: DAS181 4.5mg q12h x 7 OR 10 days
arm group label: DAS181 COVID-19 Placebo
arm group type: Placebo Comparator
description: Placebo q12h x 7 OR 10 days
intervention type: Drug
intervention name: DAS181
description: DAS181 4.5mg nebulized qd x 7 OR 10 days
arm group label: Cohort 1 and Cohort 2 Treatment
intervention type: Drug
intervention name: Placebo
description: Placebo nebulized qd x 7 OR 10 days
arm group label: Cohort 1 and Cohort 2 Placebo
arm group label: DAS181 COVID-19 Placebo
intervention type: Drug
intervention name: DAS181 COVID-19
description: DAS181 4.5mg nebulized q12h/day x 7 OR 10 days
arm group label: DAS181 COVID-19 Treatment
intervention type: Drug
intervention name: DAS181 OL
description: DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days < 40kg
arm group label: Cohort 3
arm group label: Cohort 4
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: George Wang
role: Study Director
affiliation: Ansun Biopharma, Inc.
last name: Lisa Li
phone: 858-353-4948
email: lli@ansunbiopharma.com
last name: Danielle Slemons
email: dslemons@ansunbiopharma.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Withdrawn
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
country: Australia
country: China
country: Denmark
country: France
country: Hong Kong
country: Korea, Republic of
country: Taiwan
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: COVID-19
mesh term: Respiratory Tract Infections
mesh term: Paramyxoviridae Infections