<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/NCT04414124</url>
  </required_header>
  <id_info>
    <org_study_id>K031-120</org_study_id>
    <nct_id>NCT04414124</nct_id>
  </id_info>
  <brief_title>A Clinical Study to Assess the Natural History of COVID-19 and Effects of KB109 and Supportive Self-care in Outpatients With Mild-to-moderate COVID-19</brief_title>
  <official_title>A Randomized, Open Label, Prospective, Parallel Group Study to Assess the Natural History of COVID-19 and Effects of KB109 in Addition to Supportive Self Care (SSC) Compared to SSC Alone on Measures of Health in Non-hospitalized Patients With Mild-Moderate COVID-19</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 randomized, open-label, prospective, parallel-group controlled clinical study that aims&#xD;
      to explore the natural history of COVID-19 illness and the safety of KB109, a novel glycan,&#xD;
      plus SSC versus SSC alone and measures of health in outpatients with mild-to-moderate&#xD;
      COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2020</start_date>
  <completion_date type="Actual">February 2, 2021</completion_date>
  <primary_completion_date type="Actual">February 2, 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>Change from baseline to end of intake in overall composite COVID-19 symptom score</measure>
    <time_frame>Day 1 to Day 35</time_frame>
    <description>The composite COVID-19 symptom score is the sum of the 8 cardinal COVID-19 related symptom scores (cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, and sore throat). Each COVID-19 symptom will be recorded by patients on a scale of 0: Absent, 1: Mild: Moderately severe. The overall composite score ranges from 0 (no symptoms) to 24 (very severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to resolution of fever</measure>
    <time_frame>Day 1 to Day 35</time_frame>
    <description>Resolution of fever is defined as from Day 1 until the day at which a patient's daily maximum temperature achieves and remains below 100.4 Degrees Fahrenheit for the rest of the intake period and for the follow-up period without an antipyretic medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with decreased oxygen saturation</measure>
    <time_frame>Day 14, Day 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of COVID-19 symptoms on physical activities</measure>
    <time_frame>Day 1 to Day 35</time_frame>
    <description>Effect of COVID-19 symptoms on physical activities rated as: not at all, very little, somewhat, quite a lot, could not do physical activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients requiring hospitalization</measure>
    <time_frame>Day 1 to Day 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to resolution of overall 13 COVID-19 related symptoms.</measure>
    <time_frame>Day 1 to Day 35</time_frame>
    <description>Defined as from Day 1 until the day at which the overall composite score of 13 COVID-19 related symptoms becomes 0 or 1 and remains at 0 or 1 for the rest of the Intake Period and for the Follow-up Period. Overall composite score of 13 COVID-19 related symptoms is the sum of 13 COVID-19 related symptom scores (i.e., cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, sore throat, gastrointestinal disturbance/symptoms, diarrhea, fatigue, nasal congestion, and chest tightness (CDC 2020). Each COVID-19 symptom will be recorded by patients on a scale of 0: Absent, 1: Mild, 2: Moderately severe, 3: Very severe. The overall composite score ranges from 0 (no symptoms) to 39 (very severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to resolution of overall 8 cardinal COVID-19 related symptoms.</measure>
    <time_frame>Day 1 to Day 35</time_frame>
    <description>Defined as from Day 1 until the day at which the overall composite score of 8 cardinal COVID-19 related symptoms 0 or 1 and remains at 0 or 1 for the rest of the Intake Period and for the Follow-up Period. Overall composite score of 8 cardinal COVID-19 related symptoms is the sum of 8 cardinal COVID-19 related symptom scores (i.e., cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, and sore throat).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">350</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>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be male or female, ≥18 years of age&#xD;
&#xD;
          -  Be willing and able to give informed consent&#xD;
&#xD;
          -  Screening/Randomization telemedicine visit within 2 days of testing positive test for&#xD;
             COVID-19&#xD;
&#xD;
          -  Having self-reported fever or cough for not more than 72 hours prior to COVID-19&#xD;
             testing&#xD;
&#xD;
          -  Mild to moderate COVID-19&#xD;
&#xD;
          -  Able to adhere to the study visit schedule and other protocol requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  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;
          -  History of chronic lung disease&#xD;
&#xD;
          -  Ongoing requirement for oxygen therapy&#xD;
&#xD;
          -  Shortness of breath in resting position&#xD;
&#xD;
          -  Diagnosis of sleep apnea requiring Bilevel Positive Airway Pressure (BIPAP) /&#xD;
             Continuous Positive Airway Pressure (CPAP)&#xD;
&#xD;
          -  Female patients who are pregnant, trying to become pregnant or lactating&#xD;
&#xD;
          -  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>Healthstar Research</name>
      <address>
        <city>Hot Springs</city>
        <state>Arkansas</state>
        <zip>71913</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Axon Clinical Research</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center for Clinical Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vista Health Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bio-Medical Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33184</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Vernon Clinical Research</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centex Studies, Inc. - Lake Charles</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts Medical School</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research - Clinical Research Center of Nevada, LLC</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Institute For Clinical Research</name>
      <address>
        <city>Fayetteville</city>
        <state>North Carolina</state>
        <zip>28304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M3 Wake Research, Inc</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TruCare Internal Medicine and Infectious Diseases</name>
      <address>
        <city>DuBois</city>
        <state>Pennsylvania</state>
        <zip>15801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinSearch LLC</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Global Medical Research</name>
      <address>
        <city>DeSoto</city>
        <state>Texas</state>
        <zip>75115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centex Studies</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infectious Diseases Associates of Central Virginia</name>
      <address>
        <city>Lynchburg</city>
        <state>Virginia</state>
        <zip>24501</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>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 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>Oligosaccharide</keyword>
  <keyword>Glycan</keyword>
  <keyword>Pathogens</keyword>
  <keyword>Microbiome metabolic therapy</keyword>
  <keyword>MMT</keyword>
  <keyword>Supportive Self Care</keyword>
  <keyword>SSC</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>
  <!-- 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/NCT04414124
org study id: K031-120
nct id: NCT04414124
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized, open-label, prospective, parallel-group controlled clinical study that aims
      to explore the natural history of COVID-19 illness and the safety of KB109, a novel glycan,
      plus SSC versus SSC alone and measures of health in outpatients with mild-to-moderate
      COVID-19.
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: Change from baseline to end of intake in overall composite COVID-19 symptom score
time frame: Day 1 to Day 35
description: The composite COVID-19 symptom score is the sum of the 8 cardinal COVID-19 related symptom scores (cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, and sore throat). Each COVID-19 symptom will be recorded by patients on a scale of 0: Absent, 1: Mild: Moderately severe. The overall composite score ranges from 0 (no symptoms) to 24 (very severe)
measure: Time to resolution of fever
time frame: Day 1 to Day 35
description: Resolution of fever is defined as from Day 1 until the day at which a patient's daily maximum temperature achieves and remains below 100.4 Degrees Fahrenheit for the rest of the intake period and for the follow-up period without an antipyretic medication.
measure: Proportion of patients with decreased oxygen saturation
time frame: Day 14, Day 35
measure: Effect of COVID-19 symptoms on physical activities
time frame: Day 1 to Day 35
description: Effect of COVID-19 symptoms on physical activities rated as: not at all, very little, somewhat, quite a lot, could not do physical activities.
measure: Proportion of patients requiring hospitalization
time frame: Day 1 to Day 35
measure: Time to resolution of overall 13 COVID-19 related symptoms.
time frame: Day 1 to Day 35
description: Defined as from Day 1 until the day at which the overall composite score of 13 COVID-19 related symptoms becomes 0 or 1 and remains at 0 or 1 for the rest of the Intake Period and for the Follow-up Period. Overall composite score of 13 COVID-19 related symptoms is the sum of 13 COVID-19 related symptom scores (i.e., cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, sore throat, gastrointestinal disturbance/symptoms, diarrhea, fatigue, nasal congestion, and chest tightness (CDC 2020). Each COVID-19 symptom will be recorded by patients on a scale of 0: Absent, 1: Mild, 2: Moderately severe, 3: Very severe. The overall composite score ranges from 0 (no symptoms) to 39 (very severe).
measure: Time to resolution of overall 8 cardinal COVID-19 related symptoms.
time frame: Day 1 to Day 35
description: Defined as from Day 1 until the day at which the overall composite score of 8 cardinal COVID-19 related symptoms 0 or 1 and remains at 0 or 1 for the rest of the Intake Period and for the Follow-up Period. Overall composite score of 8 cardinal COVID-19 related symptoms is the sum of 8 cardinal COVID-19 related symptom scores (i.e., cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, and sore throat).
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: 
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country: United States
responsible party type: Sponsor
mesh term: COVID-19