<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/NCT04468971</url>
  </required_header>
  <id_info>
    <org_study_id>CK0802.501.1</org_study_id>
    <nct_id>NCT04468971</nct_id>
  </id_info>
  <brief_title>REgulatory T Cell infuSion fOr Lung Injury Due to COVID-19 PnEumonia</brief_title>
  <acronym>RESOLVE</acronym>
  <official_title>Phase 1 Double-Blinded, Randomized, Placebo Controlled Safety and Early Efficacy Trial of Cryopreserved Cord Blood Derived T-Regulatory Cell Infusions (CK0802) In The Treatment Of COVID-19 Induced Acute Respiratory Distress Syndrome (ARDS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cellenkos, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cellenkos, 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>
      To assess the safety and efficacy of CK0802 in treatment of patients with COVID-19 induced&#xD;
      moderate-to-severe PNA-ARDS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2020</start_date>
  <completion_date type="Actual">October 22, 2021</completion_date>
  <primary_completion_date type="Actual">October 22, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Multi-center, prospective, double-blinded, placebo controlled Phase 1 randomized clinical trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Regimen related ≥ grade 3 toxicity within 48 hours of first infusion</measure>
    <time_frame>48 hours</time_frame>
    <description>Regimen related ≥ grade 3 toxicity within 48 hours of first infusion (DLT)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>28-day treatment success, defined as S28</measure>
    <time_frame>28 days</time_frame>
    <description>Alive and not intubated 28 days after the date of first infusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to extubation</measure>
    <time_frame>28 days</time_frame>
    <description>Time to extubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygenation improvement</measure>
    <time_frame>11 days</time_frame>
    <description>Oxygenation requirement (PaO2/FiO2) change between day 0 and day +11</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilator free days</measure>
    <time_frame>28 days</time_frame>
    <description>Ventilator free days measured at day 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Organ failure free days</measure>
    <time_frame>28 days</time_frame>
    <description>Organ failure free days measured at day 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU free days</measure>
    <time_frame>28 days</time_frame>
    <description>ICU free days measured at day 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>28 days</time_frame>
    <description>All-cause mortality at day 28</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>COVID19</condition>
  <condition>ARDS</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Excipient</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CK0802: 1x10^8 cells</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CK0802: 3x10^8 cells</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CK0802</intervention_name>
    <description>Cryopreserved, off the shelf, cord blood derived T regulatory cells</description>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_label>Arm 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Expicient</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented to have an RT-PCR-based diagnosis of SARS-CoV-2 infection by RT-PCR&#xD;
&#xD;
          -  Moderate-to-severe ARDS as defined by the Berlin Criteria: ratio of partial pressure&#xD;
             of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) of 200 mm Hg or&#xD;
             less assessed with a positive end-expiratory pressure (PEEP) of &gt;5 cm H2O.&#xD;
&#xD;
          -  Intubated for less than 120 hours&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Ability to provide informed consent or duly appointment health care proxy with the&#xD;
             authority to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. In the opinion of the investigator, unlikely to survive for &gt;48 hours from screening.&#xD;
&#xD;
          2. Any physical examination findings and/or history of any illness that, in the opinion&#xD;
             of the study investigator, might confound the results of the study or pose an&#xD;
             additional risk to the patient by their participation in the study.&#xD;
&#xD;
          3. Currently receiving extracorporeal membrane oxygenation (ECMO) or high frequency&#xD;
             oscillatory ventilation (HFOV).&#xD;
&#xD;
          4. Females who are pregnant.&#xD;
&#xD;
          5. Patients with active bacteremia at start of therapy enrollment or concurrently active&#xD;
             moderate to severe other infectious which in the opinion of the investigator may&#xD;
             possibly affect the safety of CK0802 treatment.&#xD;
&#xD;
          6. Patients who have been intubated for more than 120 hours.&#xD;
&#xD;
          7. Known hypersensitivity to DMSO or to porcine or bovine protein.&#xD;
&#xD;
          8. Any end-stage organ disease which in the opinion of the investigator may possibly&#xD;
             affect the safety of CK0802 treatment.&#xD;
&#xD;
          9. High dose steroids.&#xD;
&#xD;
         10. Receiving an investigational cellular therapy agent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine, St Luke's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>March 8, 2022</last_update_submitted>
  <last_update_submitted_qc>March 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID19</keyword>
  <keyword>ARDS</keyword>
  <keyword>CK0802</keyword>
  <keyword>T regulatory cells</keyword>
  <keyword>cord blood</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_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/NCT04468971
org study id: CK0802.501.1
nct id: NCT04468971
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
To assess the safety and efficacy of CK0802 in treatment of patients with COVID-19 induced
      moderate-to-severe PNA-ARDS.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Multi-center, prospective, double-blinded, placebo controlled Phase 1 randomized clinical trial.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Regimen related ≥ grade 3 toxicity within 48 hours of first infusion
time frame: 48 hours
description: Regimen related ≥ grade 3 toxicity within 48 hours of first infusion (DLT)
measure: 28-day treatment success, defined as S28
time frame: 28 days
description: Alive and not intubated 28 days after the date of first infusion
measure: Time to extubation
time frame: 28 days
description: Time to extubation
measure: Oxygenation improvement
time frame: 11 days
description: Oxygenation requirement (PaO2/FiO2) change between day 0 and day +11
measure: Ventilator free days
time frame: 28 days
description: Ventilator free days measured at day 28
measure: Organ failure free days
time frame: 28 days
description: Organ failure free days measured at day 28
measure: ICU free days
time frame: 28 days
description: ICU free days measured at day 28
measure: All-cause mortality
time frame: 28 days
description: All-cause mortality at day 28
arm group label: Arm 1
arm group type: Placebo Comparator
description: Excipient
arm group label: Arm 2
arm group type: Experimental
description: CK0802: 1x10^8 cells
arm group label: Arm 3
arm group type: Experimental
description: CK0802: 3x10^8 cells
intervention type: Biological
intervention name: CK0802
description: Cryopreserved, off the shelf, cord blood derived T regulatory cells
arm group label: Arm 2
arm group label: Arm 3
intervention type: Drug
intervention name: Placebo
description: Expicient
arm group label: Arm 1
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No