<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/NCT04488575</url>
  </required_header>
  <id_info>
    <org_study_id>EDP1815-205</org_study_id>
    <nct_id>NCT04488575</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With COVID-19 Infection</brief_title>
  <official_title>A Phase 2 Double-blind Placebo-controlled Study Investigating the Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With SARS-CoV-2 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Evelo Biosciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Evelo Biosciences, 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>
      Evelo will investigate the safety and efficacy of EDP1815 in the treatment of patients&#xD;
      hospitalized with SARS-CoV-2 Infection&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, placebo-controlled clinical study to assess the safety and efficacy of&#xD;
      EDP1815 in patients hospitalized with COVID-19 infection.&#xD;
&#xD;
      The study is designed to evaluate the efficacy of EDP1815 at reducing time to resolution of&#xD;
      symptoms, preventing progression of COVID-19 symptoms and preventing COVID-Related&#xD;
      Complications (CRC)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient study defined patient population&#xD;
  </why_stopped>
  <start_date type="Actual">August 26, 2020</start_date>
  <completion_date type="Actual">May 19, 2021</completion_date>
  <primary_completion_date type="Actual">May 16, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients will be randomized to either the active (EDP1815) or placebo group (1:1 randomization), in addition to standard of care. Dosing will be initiated on a twice daily regime for the first 3 days (6 doses) and then once daily for the remaining 11 days (14 days total treatment course).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Fully blinded to the participants, investigator, and sponsor</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline to the Lowest S/F Oxygen Ratio in Days 1 to 14</measure>
    <time_frame>14 days</time_frame>
    <description>Worst pulmonary function as measured by the change in Oxygen Saturation (SpO2) / Fraction of Inspired Oxygen (FiO2) [S/F ratio]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in S/F Ratio</measure>
    <time_frame>14 days</time_frame>
    <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using change in S/F ratio at days 4, 7, 10 and 14/discharge day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage Change in S/F Ratio</measure>
    <time_frame>14 days</time_frame>
    <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage change in S/F ratio at days 4, 7, 10 and 14/discharge day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants at Each Level on the WHO OSCI Score</measure>
    <time_frame>42 days</time_frame>
    <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants at each level on the WHO OSCI score at days 4, 7, 14, 21 and 42.&#xD;
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=unifected - 8=death)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline</measure>
    <time_frame>42 days</time_frame>
    <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants with shifts from each level of the WHO OSCI score at baseline at days 4, 7, 14, 21 and 42.&#xD;
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower)</measure>
    <time_frame>42 days</time_frame>
    <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants remaining at their baseline score on the WHO OSCI (or lower) at days 4, 7, 14, 21 and 42. Once a participant has increased their WHO OSCI score they are not considered to have remained at or below their baseline value at future visits regardless of whether their score returns to or below their baseline value.&#xD;
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day</measure>
    <time_frame>42 days</time_frame>
    <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants reporting each level of the WHO OSCI score at their worst post-baseline day.&#xD;
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death).</measure>
    <time_frame>42 days</time_frame>
    <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the time in days spent at each participant's worst reported WHO OSCI score (excluding death).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intubation and Mechanical-ventilation Free Survival</measure>
    <time_frame>42 days</time_frame>
    <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the intubation and mechanical-ventilation free survival, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 6 or more.&#xD;
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>42 days</time_frame>
    <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using overall survival, defined as the time in days from start of treatment to death by any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days Requiring Oxygen Therapy</measure>
    <time_frame>42 days</time_frame>
    <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days requiring oxygen therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days With Pyrexia</measure>
    <time_frame>42 days</time_frame>
    <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days with pyrexia ≥ 38C</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Daily Temperature</measure>
    <time_frame>42 days</time_frame>
    <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using maximum daily temperature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SpO2 Level</measure>
    <time_frame>42 days</time_frame>
    <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using minimum and maximum SpO2 levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Discharge</measure>
    <time_frame>42 days</time_frame>
    <description>The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to discharge, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 2 or less.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Oxygen Saturation (SpO2) ≥94%</measure>
    <time_frame>42 days</time_frame>
    <description>The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to oxygen saturation (SpO2) ≥94% on room air without further requirement for oxygen therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Recovery</measure>
    <time_frame>42 days</time_frame>
    <description>The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to recovery, defined as the time in days from symptom onset to alleviation of all COVID-19 symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment</measure>
    <time_frame>42 days</time_frame>
    <description>The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by relationship to treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Clinically Significant Abnormal Lab Parameters</measure>
    <time_frame>42 days</time_frame>
    <description>The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing clinically significant abnormal changes in safety lab parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment</measure>
    <time_frame>42 days</time_frame>
    <description>The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by seriousness</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>EDP1815</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive EDP1815 in addition to standard of care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will receive placebo in addition to standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EDP1815</intervention_name>
    <description>EDP1815 is an orally administered monoclonal microbe</description>
    <arm_group_label>EDP1815</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo oral capsule</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Hospitalized within the last 36 hours.&#xD;
&#xD;
          2. Receiving any form of supplementary oxygen therapy at baseline.&#xD;
&#xD;
          3. Confirmed COVID-19 viral infection by RTPCR at screening.&#xD;
&#xD;
          4. Age:&#xD;
&#xD;
               1. 18-65 years old, OR&#xD;
&#xD;
               2. &gt;65 year-olds can be included after Data Monitoring Committee (DMC) approval&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Contraindications/hypersensitivity to P histicola or any of the capsule excipients&#xD;
&#xD;
          2. Patients with chronic hypoxia or underlying significant chronic respiratory disease&#xD;
             (such as Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Fibrosis, or&#xD;
             Bronchiectasis).&#xD;
&#xD;
          3. Admission to ICU at time of screening.&#xD;
&#xD;
          4. Mechanically ventilated, on continuous positive airway pressure (CPAP), or on&#xD;
             non-invasive ventilation at the time of screening.&#xD;
&#xD;
          5. Patient is taking a systemic immunosuppressive agent such as, but not limited to, oral&#xD;
             steroids, methotrexate, azathioprine, ciclosporin, or tacrolimus, unless these are&#xD;
             given as part of COVID standard of care treatment.&#xD;
&#xD;
          6. Patient has a diagnosed primary immunodeficiency.&#xD;
&#xD;
          7. Patient has a diagnosis of HIV/AIDS&#xD;
&#xD;
          8. Patient has pre-existing known chronic kidney disease stage 4 or 5 or requiring renal&#xD;
             replacement therapy (i.e. estimated glomerular filtration rate (eGFR)&#xD;
             &lt;30ml/min/1.73m2)&#xD;
&#xD;
          9. Patient has pre-existing known significant liver disease with Alanine aminotransferase&#xD;
             (ALT) or aspartate aminotransferase (AST) ≥ 5.0 x upper limit of normal (ULN)&#xD;
&#xD;
         10. Patient has pre-existing known significant gastrointestinal tract disease expected to&#xD;
             affect absorption within the small intestine (e.g. short bowel syndrome, inflammatory&#xD;
             bowel disease affecting the small intestine, gastroparesis); or prior malabsorptive&#xD;
             bariatric surgery that could interfere with GI delivery and transit time.&#xD;
&#xD;
         11. GI signs or symptoms equivalent to CTCAE v5.0, gastrointestinal disorders, grade 3 or&#xD;
             4 event.&#xD;
&#xD;
         12. Patient has pre-existing known substantially impaired cardiac function or pre-existing&#xD;
             clinically significant cardiac diseases, including unstable angina or acute myocardial&#xD;
             infarction ≤ 6 weeks prior to Screening.&#xD;
&#xD;
         13. Currently participating in an interventional clinical trial (observational studies&#xD;
             allowed).&#xD;
&#xD;
         14. Moribund at time of screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Reynold Panettieri, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rutgers, The State University of New Jersey</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Douglas Maslin, MD</last_name>
    <role>Study Director</role>
    <affiliation>Evelo Biosciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Robert Wood Johnson University Hospital</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University Hospital</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DHR Health Institute</name>
      <address>
        <city>Edinburg</city>
        <state>Texas</state>
        <zip>78539</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hacettepe University Adult Hospital</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <results_first_submitted>July 22, 2022</results_first_submitted>
  <results_first_submitted_qc>November 22, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 19, 2022</results_first_posted>
  <last_update_submitted>November 22, 2022</last_update_submitted>
  <last_update_submitted_qc>November 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS-CoV-2</keyword>
  <keyword>corona virus</keyword>
  <keyword>coronavirus</keyword>
  <keyword>corona</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 5, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT04488575/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 11, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT04488575/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
        </group>
        <group group_id="P2">
          <title>EDP1815</title>
          <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
        </group>
        <group group_id="B2">
          <title>EDP1815</title>
          <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="7"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="16"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to the Lowest S/F Oxygen Ratio in Days 1 to 14</title>
        <description>Worst pulmonary function as measured by the change in Oxygen Saturation (SpO2) / Fraction of Inspired Oxygen (FiO2) [S/F ratio]</description>
        <time_frame>14 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>EDP1815</title>
            <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to the Lowest S/F Oxygen Ratio in Days 1 to 14</title>
          <description>Worst pulmonary function as measured by the change in Oxygen Saturation (SpO2) / Fraction of Inspired Oxygen (FiO2) [S/F ratio]</description>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.0" spread="114.95"/>
                    <measurement group_id="O2" value="-63.8" spread="76.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in S/F Ratio</title>
        <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using change in S/F ratio at days 4, 7, 10 and 14/discharge day.</description>
        <time_frame>14 days</time_frame>
        <population>All participants providing data at the relevant timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>EDP1815</title>
            <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
          </group>
        </group_list>
        <measure>
          <title>Change in S/F Ratio</title>
          <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using change in S/F ratio at days 4, 7, 10 and 14/discharge day.</description>
          <population>All participants providing data at the relevant timepoints.</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.4" lower_limit="-59.0" upper_limit="148.0"/>
                    <measurement group_id="O2" value="-23.0" lower_limit="-188.0" upper_limit="167.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.0" lower_limit="-65.0" upper_limit="20.0"/>
                    <measurement group_id="O2" value="-86.7" lower_limit="-130.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.0" lower_limit="-68.0" upper_limit="142.0"/>
                    <measurement group_id="O2" value="-111.0" lower_limit="-115.0" upper_limit="-107.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-83.0" lower_limit="-83.0" upper_limit="-83.0"/>
                    <measurement group_id="O2" value="-14.0" lower_limit="-53.0" upper_limit="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Change in S/F Ratio</title>
        <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage change in S/F ratio at days 4, 7, 10 and 14/discharge day.</description>
        <time_frame>14 days</time_frame>
        <population>All participants providing data at the relevant timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>EDP1815</title>
            <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change in S/F Ratio</title>
          <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage change in S/F ratio at days 4, 7, 10 and 14/discharge day.</description>
          <population>All participants providing data at the relevant timepoints.</population>
          <units>percentage change</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.97" lower_limit="-33.1" upper_limit="49.3"/>
                    <measurement group_id="O2" value="-5.33" lower_limit="-66.0" upper_limit="104.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.41" lower_limit="-36.5" upper_limit="8.4"/>
                    <measurement group_id="O2" value="-36.48" lower_limit="-57.6" upper_limit="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109.7" lower_limit="-38.2" upper_limit="147.9"/>
                    <measurement group_id="O2" value="-46.6" lower_limit="-48.7" upper_limit="-44.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-46.6" lower_limit="-46.6" upper_limit="-46.6"/>
                    <measurement group_id="O2" value="-5.7" lower_limit="-22.0" upper_limit="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants at Each Level on the WHO OSCI Score</title>
        <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants at each level on the WHO OSCI score at days 4, 7, 14, 21 and 42.&#xD;
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=unifected - 8=death)</description>
        <time_frame>42 days</time_frame>
        <population>All participants providing data at the relevant timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>EDP1815</title>
            <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants at Each Level on the WHO OSCI Score</title>
          <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants at each level on the WHO OSCI score at days 4, 7, 14, 21 and 42.&#xD;
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=unifected - 8=death)</description>
          <population>All participants providing data at the relevant timepoints.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>WHO OSCI score - 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>WHO OSCI score - 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>WHO OSCI score - 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>WHO OSCI score - 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 42</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>WHO OSCI score - 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>WHO OSCI score - 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline</title>
        <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants with shifts from each level of the WHO OSCI score at baseline at days 4, 7, 14, 21 and 42.&#xD;
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)</description>
        <time_frame>42 days</time_frame>
        <population>All participants providing data at the relevant timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>EDP1815</title>
            <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline</title>
          <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants with shifts from each level of the WHO OSCI score at baseline at days 4, 7, 14, 21 and 42.&#xD;
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)</description>
          <population>All participants providing data at the relevant timepoints.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 42</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 4; WHO OSCI Score - 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Baseline WHO OSCI score 5; WHO OSCI Score - 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower)</title>
        <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants remaining at their baseline score on the WHO OSCI (or lower) at days 4, 7, 14, 21 and 42. Once a participant has increased their WHO OSCI score they are not considered to have remained at or below their baseline value at future visits regardless of whether their score returns to or below their baseline value.&#xD;
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)</description>
        <time_frame>42 days</time_frame>
        <population>All participants providing data at the relevant timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>EDP1815</title>
            <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower)</title>
          <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants remaining at their baseline score on the WHO OSCI (or lower) at days 4, 7, 14, 21 and 42. Once a participant has increased their WHO OSCI score they are not considered to have remained at or below their baseline value at future visits regardless of whether their score returns to or below their baseline value.&#xD;
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)</description>
          <population>All participants providing data at the relevant timepoints.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 42</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day</title>
        <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants reporting each level of the WHO OSCI score at their worst post-baseline day.&#xD;
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)</description>
        <time_frame>42 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>EDP1815</title>
            <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day</title>
          <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants reporting each level of the WHO OSCI score at their worst post-baseline day.&#xD;
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Score = 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death).</title>
        <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the time in days spent at each participant's worst reported WHO OSCI score (excluding death).</description>
        <time_frame>42 days</time_frame>
        <population>All participants providing data at the relevant timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>EDP1815</title>
            <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
          </group>
        </group_list>
        <measure>
          <title>The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death).</title>
          <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the time in days spent at each participant's worst reported WHO OSCI score (excluding death).</description>
          <population>All participants providing data at the relevant timepoints.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Score = 3; 1 day</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 3; 2-3 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 3; 4-7 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 3; &gt;7 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 4; 1 day</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 4; 2-3 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 4; 4-7 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 4; &gt;7 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 5: 1 day</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 5; 2-3 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 5; 4-7 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 5; &gt;7days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 6; 1 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 6; 2-3 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 6; 4-7 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 6; &gt;7 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Score = 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intubation and Mechanical-ventilation Free Survival</title>
        <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the intubation and mechanical-ventilation free survival, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 6 or more.&#xD;
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)</description>
        <time_frame>42 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>EDP1815</title>
            <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
          </group>
        </group_list>
        <measure>
          <title>Intubation and Mechanical-ventilation Free Survival</title>
          <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the intubation and mechanical-ventilation free survival, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 6 or more.&#xD;
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Number of pts who died or required intubation/mechanical ventilation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of participants censored</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</title>
        <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using overall survival, defined as the time in days from start of treatment to death by any cause</description>
        <time_frame>42 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>EDP1815</title>
            <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using overall survival, defined as the time in days from start of treatment to death by any cause</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Number of participants who died</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of participants censored</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days Requiring Oxygen Therapy</title>
        <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days requiring oxygen therapy</description>
        <time_frame>42 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>EDP1815</title>
            <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days Requiring Oxygen Therapy</title>
          <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days requiring oxygen therapy</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Days 1-14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" spread="5.01"/>
                    <measurement group_id="O2" value="6.8" spread="4.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Days 1-28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9" spread="9.30"/>
                    <measurement group_id="O2" value="8.8" spread="8.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Days 1-42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9" spread="14.28"/>
                    <measurement group_id="O2" value="9" spread="9.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days With Pyrexia</title>
        <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days with pyrexia ≥ 38C</description>
        <time_frame>42 days</time_frame>
        <population>All participants providing data within the relevant interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>EDP1815</title>
            <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days With Pyrexia</title>
          <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days with pyrexia ≥ 38C</description>
          <population>All participants providing data within the relevant interval.</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Days 1-14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.38"/>
                    <measurement group_id="O2" value="0.4" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Days 1-28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.38"/>
                    <measurement group_id="O2" value="0.4" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Days 1-42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.38"/>
                    <measurement group_id="O2" value="0.4" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Daily Temperature</title>
        <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using maximum daily temperature</description>
        <time_frame>42 days</time_frame>
        <population>All participants providing data within the relevant interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>EDP1815</title>
            <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Daily Temperature</title>
          <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using maximum daily temperature</description>
          <population>All participants providing data within the relevant interval.</population>
          <units>degress c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Days 1-14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.21" spread="0.414"/>
                    <measurement group_id="O2" value="37.32" spread="0.854"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Days 1-28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.21" spread="0.414"/>
                    <measurement group_id="O2" value="37.32" spread="0.854"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Days 1-42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.21" spread="0.414"/>
                    <measurement group_id="O2" value="37.32" spread="0.854"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>SpO2 Level</title>
        <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using minimum and maximum SpO2 levels</description>
        <time_frame>42 days</time_frame>
        <population>All participants providing data within the relevant interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>EDP1815</title>
            <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
          </group>
        </group_list>
        <measure>
          <title>SpO2 Level</title>
          <description>The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using minimum and maximum SpO2 levels</description>
          <population>All participants providing data within the relevant interval.</population>
          <units>percentage of oxygen saturation</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Days 1-7 (min)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.3" spread="2.43"/>
                    <measurement group_id="O2" value="91.7" spread="2.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Days 1-7 (max)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.0" spread="1.83"/>
                    <measurement group_id="O2" value="96.7" spread="2.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Days 1-14 (min)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.0" spread="2.71"/>
                    <measurement group_id="O2" value="91.7" spread="2.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Days 1-14 (max)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.0" spread="1.83"/>
                    <measurement group_id="O2" value="97.1" spread="2.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Days 1-28 (min)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.0" spread="2.71"/>
                    <measurement group_id="O2" value="91.7" spread="2.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Days 1-28 (max)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.0" spread="1.83"/>
                    <measurement group_id="O2" value="97.1" spread="2.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Days 1-42 (min)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.0" spread="2.71"/>
                    <measurement group_id="O2" value="91.7" spread="2.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Days 1-42 (max)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.6" spread="2.07"/>
                    <measurement group_id="O2" value="97.1" spread="2.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Discharge</title>
        <description>The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to discharge, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 2 or less.</description>
        <time_frame>42 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>EDP1815</title>
            <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Discharge</title>
          <description>The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to discharge, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 2 or less.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Number of participants discharged</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of participants who died</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of participants censored</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Oxygen Saturation (SpO2) ≥94%</title>
        <description>The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to oxygen saturation (SpO2) ≥94% on room air without further requirement for oxygen therapy.</description>
        <time_frame>42 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>EDP1815</title>
            <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Oxygen Saturation (SpO2) ≥94%</title>
          <description>The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to oxygen saturation (SpO2) ≥94% on room air without further requirement for oxygen therapy.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Number of participants who achieved SpO2 &gt;=94% without further requirement for oxygen therapy</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of participants who died</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of participants censored</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Recovery</title>
        <description>The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to recovery, defined as the time in days from symptom onset to alleviation of all COVID-19 symptoms.</description>
        <time_frame>42 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>EDP1815</title>
            <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Recovery</title>
          <description>The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to recovery, defined as the time in days from symptom onset to alleviation of all COVID-19 symptoms.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Number of participants who recovered</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of participants who died</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of participants censored</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment</title>
        <description>The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by relationship to treatment</description>
        <time_frame>42 days</time_frame>
        <population>The numbers analyzed only includes those participants who experienced adverse events.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>EDP1815</title>
            <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment</title>
          <description>The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by relationship to treatment</description>
          <population>The numbers analyzed only includes those participants who experienced adverse events.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Acute Respiratory Distress Syndrome : Not related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acute Respiratory Distress Syndrome : Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhoea : Not related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhoea : Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal distension : Not related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal distension : Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension : Not related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension : Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Clinically Significant Abnormal Lab Parameters</title>
        <description>The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing clinically significant abnormal changes in safety lab parameters</description>
        <time_frame>42 days</time_frame>
        <population>Any clinically significant abnormal lab parameters were included as AEs.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>EDP1815</title>
            <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Clinically Significant Abnormal Lab Parameters</title>
          <description>The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing clinically significant abnormal changes in safety lab parameters</description>
          <population>Any clinically significant abnormal lab parameters were included as AEs.</population>
          <units>number of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment</title>
        <description>The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by seriousness</description>
        <time_frame>42 days</time_frame>
        <population>Only serious AEs, AEs of CTCAE Grade 3 or above and AEs of special interest (all CTCAE grades) were documented and included in the summary.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
          </group>
          <group group_id="O2">
            <title>EDP1815</title>
            <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment</title>
          <description>The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by seriousness</description>
          <population>Only serious AEs, AEs of CTCAE Grade 3 or above and AEs of special interest (all CTCAE grades) were documented and included in the summary.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Acute Respiratory Distress Syndrome</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhoea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal distension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events (AE) and Serious Adverse Events (SAE) were documented from the point of informed consent up until 28 days post last administration of Investigational Medicinal Product (IMP), a maximum of up to 42 days post first administration of IMP.</time_frame>
      <desc>AEs were reported by the participant. Due to the nature of the patient population and disease, only SAEs and AEs of severe (CTCAE Grade 3) and potentially life threatening (CTCAE Grade 4) intensity were documented in the Case Report Form (CRF). AEs of mild (CTCAE Grade 1) or moderate (CTCAE Grade 2) intensity were documented in the medical notes. Adverse events relating to nausea, vomiting, diarrhoea, bloating and abdominal pain of any grade were recorded and assessed as an adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Patients will receive placebo in addition to standard of care&#xD;
Placebo: Placebo oral capsule</description>
        </group>
        <group group_id="E2">
          <title>EDP1815</title>
          <description>Patients will receive EDP1815 in addition to standard of care&#xD;
EDP1815: EDP1815 is an orally administered monoclonal microbe</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Duncan McHale, MBBS, MRCP, PhD</name_or_title>
      <organization>Evelo Biosciences Inc</organization>
      <phone>+447500128938</phone>
      <email>duncan@evelobio.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04488575
org study id: EDP1815-205
nct id: NCT04488575
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Evelo will investigate the safety and efficacy of EDP1815 in the treatment of patients
      hospitalized with SARS-CoV-2 Infection
This is a randomized, placebo-controlled clinical study to assess the safety and efficacy of
      EDP1815 in patients hospitalized with COVID-19 infection.

      The study is designed to evaluate the efficacy of EDP1815 at reducing time to resolution of
      symptoms, preventing progression of COVID-19 symptoms and preventing COVID-Related
      Complications (CRC)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomized to either the active (EDP1815) or placebo group (1:1 randomization), in addition to standard of care. Dosing will be initiated on a twice daily regime for the first 3 days (6 doses) and then once daily for the remaining 11 days (14 days total treatment course).
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Fully blinded to the participants, investigator, and sponsor
measure: Change From Baseline to the Lowest S/F Oxygen Ratio in Days 1 to 14
time frame: 14 days
description: Worst pulmonary function as measured by the change in Oxygen Saturation (SpO2) / Fraction of Inspired Oxygen (FiO2) [S/F ratio]
measure: Change in S/F Ratio
time frame: 14 days
description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using change in S/F ratio at days 4, 7, 10 and 14/discharge day.
measure: Percentage Change in S/F Ratio
time frame: 14 days
description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage change in S/F ratio at days 4, 7, 10 and 14/discharge day.
measure: Percentage of Participants at Each Level on the WHO OSCI Score
time frame: 42 days
description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants at each level on the WHO OSCI score at days 4, 7, 14, 21 and 42.
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=unifected - 8=death)
measure: Percentage of Participants With Shifts From Each Level of the WHO OSCI Score at Baseline
time frame: 42 days
description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants with shifts from each level of the WHO OSCI score at baseline at days 4, 7, 14, 21 and 42.
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)
measure: Number of Participants Remaining at Their Baseline Score on the WHO OSCI (or Lower)
time frame: 42 days
description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants remaining at their baseline score on the WHO OSCI (or lower) at days 4, 7, 14, 21 and 42. Once a participant has increased their WHO OSCI score they are not considered to have remained at or below their baseline value at future visits regardless of whether their score returns to or below their baseline value.
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)
measure: Percentage of Participants Reporting Each Level of the WHO OSCI Score at Their Worst Post-baseline Day
time frame: 42 days
description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants reporting each level of the WHO OSCI score at their worst post-baseline day.
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)
measure: The Time in Days Spent at Each Participant's Worst Reported WHO OSCI Score (Excluding Death).
time frame: 42 days
description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the time in days spent at each participant's worst reported WHO OSCI score (excluding death).
measure: Intubation and Mechanical-ventilation Free Survival
time frame: 42 days
description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the intubation and mechanical-ventilation free survival, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 6 or more.
(WHO OSCI - World health Organization, Ordinal Scale for Clinical Improvement; 0=uninfected - 8=death)
measure: Overall Survival
time frame: 42 days
description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using overall survival, defined as the time in days from start of treatment to death by any cause
measure: Number of Days Requiring Oxygen Therapy
time frame: 42 days
description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days requiring oxygen therapy
measure: Number of Days With Pyrexia
time frame: 42 days
description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days with pyrexia ≥ 38C
measure: Maximum Daily Temperature
time frame: 42 days
description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using maximum daily temperature
measure: SpO2 Level
time frame: 42 days
description: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using minimum and maximum SpO2 levels
measure: Time to Discharge
time frame: 42 days
description: The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to discharge, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 2 or less.
measure: Time to Oxygen Saturation (SpO2) ≥94%
time frame: 42 days
description: The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to oxygen saturation (SpO2) ≥94% on room air without further requirement for oxygen therapy.
measure: Time to Recovery
time frame: 42 days
description: The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to recovery, defined as the time in days from symptom onset to alleviation of all COVID-19 symptoms.
measure: Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment
time frame: 42 days
description: The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by relationship to treatment
measure: Incidence of Clinically Significant Abnormal Lab Parameters
time frame: 42 days
description: The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing clinically significant abnormal changes in safety lab parameters
measure: Number of Participants Experiencing AEs by Seriousness and Relationship to Treatment
time frame: 42 days
description: The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by seriousness
arm group label: EDP1815
arm group type: Experimental
description: Patients will receive EDP1815 in addition to standard of care
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients will receive placebo in addition to standard of care
intervention type: Drug
intervention name: EDP1815
description: EDP1815 is an orally administered monoclonal microbe
arm group label: EDP1815
intervention type: Drug
intervention name: Placebo
description: Placebo oral capsule
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Reynold Panettieri, MD
role: Principal Investigator
affiliation: Rutgers, The State University of New Jersey
last name: Douglas Maslin, MD
role: Study Director
affiliation: Evelo Biosciences
facility: 
facility: 
facility: 
facility: 
country: Turkey
country: United States
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 