<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/NCT04486482</url>
  </required_header>
  <id_info>
    <org_study_id>K032-120</org_study_id>
    <nct_id>NCT04486482</nct_id>
  </id_info>
  <brief_title>A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function</brief_title>
  <official_title>An Exploratory, Open Label, Clinical Study to Evaluate the Physiologic Effects of KB109 in Adult Patients With Mild-to-Moderate COVID-19 on Gut Microbiota Structure and Function in the Outpatient Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaleido Biosciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaleido Biosciences</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>
      This exploratory, open-label clinical study aims to explore the physiologic effects of KB109,&#xD;
      a novel glycan, on adult patients with COVID-19 illness on gut microbiota structure and&#xD;
      function in the outpatient setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 12, 2021</start_date>
  <completion_date type="Actual">March 30, 2021</completion_date>
  <primary_completion_date type="Actual">March 30, 2021</primary_completion_date>
  <phase>N/A</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)</measure>
    <time_frame>Day 1 to Day 35</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing.</measure>
    <time_frame>Day 1 to Day 35</time_frame>
    <description>Change from baseline in relative abundance of microbial taxa (operational taxanomic units) in the KB109 + SSC group versus SSC alone</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Mild-to-Moderate COVID-19</condition>
  <arm_group>
    <arm_group_label>KB109 + Self Supportive Care (SSC)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Self Supportive Care (SSC) Alone</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>KB109 + Self Supportive Care (SSC)</intervention_name>
    <description>KB109 is a novel glycan</description>
    <arm_group_label>KB109 + Self Supportive Care (SSC)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self Supportive Care (SSC) Alone</intervention_name>
    <description>Self Supportive Care (SSC) Alone</description>
    <arm_group_label>Self Supportive Care (SSC) Alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        To be considered for enrollment into this study, each patient must meet all of the&#xD;
        following Inclusion Criteria:&#xD;
&#xD;
          1. Be male or female, ≥18 years of age&#xD;
&#xD;
          2. Be willing and able to give informed consent&#xD;
&#xD;
          3. Screening/Randomization telemedicine visit within 2 days of testing positive test for&#xD;
             COVID-19&#xD;
&#xD;
          4. Having self-reported fever or cough for not more than 72 hours prior to COVID-19&#xD;
             testing&#xD;
&#xD;
          5. Mild to moderate COVID-19&#xD;
&#xD;
          6. Able to adhere to the study visit schedule and other protocol requirements&#xD;
&#xD;
        Patients who meet any of the following Exclusion Criteria at the Randomization Visit will&#xD;
        not be enrolled into the study:&#xD;
&#xD;
          1. Patients who are hospitalized for in-patient treatment or currently being evaluated&#xD;
             for potential hospitalization at the time of informed consent for conditions other&#xD;
             than COVID-19&#xD;
&#xD;
          2. History of chronic lung disease&#xD;
&#xD;
          3. Ongoing requirement for oxygen therapy&#xD;
&#xD;
          4. Shortness of breath in resting position&#xD;
&#xD;
          5. Diagnosis of sleep apnea requiring Bilevel Positive Airway Pressure (BIPAP) /&#xD;
             Continuous Positive Airway Pressure (CPAP)&#xD;
&#xD;
          6. Female patients who are pregnant, trying to become pregnant or lactating.&#xD;
&#xD;
          7. Is considered, in the opinion of the PI, to be unlikely for any reason to be able to&#xD;
             comply with study procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Wingertzahn, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Kaleido Biosciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cullman Clinical Trials</name>
      <address>
        <city>Cullman</city>
        <state>Alabama</state>
        <zip>35055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Institute of Research</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rancho Cucamonga Clinical Research</name>
      <address>
        <city>Rancho Cucamonga</city>
        <state>California</state>
        <zip>91730</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Next Phase Research Alliance</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Pharma CR, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33147</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hope Clinical Trials</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kendall South Medical Center, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33185</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quad Clinical Research</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inquest Research</name>
      <address>
        <city>Baytown</city>
        <state>Texas</state>
        <zip>77521</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Olympus Family Medicine</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Ogden Family Medicine Center</name>
      <address>
        <city>South Ogden</city>
        <state>Utah</state>
        <zip>84405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>August 12, 2021</last_update_submitted>
  <last_update_submitted_qc>August 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Microbiome</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Corona Virus</keyword>
  <keyword>Corona Virus Disease</keyword>
  <keyword>Kaleido</keyword>
  <keyword>Kaleido Biosciences</keyword>
  <keyword>KB109</keyword>
  <keyword>Oligosaccharides</keyword>
  <keyword>Glycan</keyword>
  <keyword>Outpatient</keyword>
  <keyword>Pathogens</keyword>
  <keyword>Microbiome Metabolic Therapy</keyword>
  <keyword>MMT</keyword>
  <keyword>Telemedicine</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/NCT04486482
org study id: K032-120
nct id: NCT04486482
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This exploratory, open-label clinical study aims to explore the physiologic effects of KB109,
      a novel glycan, on adult patients with COVID-19 illness on gut microbiota structure and
      function in the outpatient setting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)
time frame: Day 1 to Day 35
measure: Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing.
time frame: Day 1 to Day 35
description: Change from baseline in relative abundance of microbial taxa (operational taxanomic units) in the KB109 + SSC group versus SSC alone
arm group label: KB109 + Self Supportive Care (SSC)
arm group type: Other
arm group label: Self Supportive Care (SSC) Alone
arm group type: Other
intervention type: Other
intervention name: KB109 + Self Supportive Care (SSC)
description: KB109 is a novel glycan
arm group label: KB109 + Self Supportive Care (SSC)
intervention type: Other
intervention name: Self Supportive Care (SSC) Alone
description: Self Supportive Care (SSC) Alone
arm group label: Self Supportive Care (SSC) Alone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Wingertzahn, PhD
role: Study Director
affiliation: Kaleido Biosciences
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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country: United States
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No