<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/NCT04493242</url>
  </required_header>
  <id_info>
    <org_study_id>DB-EF-PHASEII-001</org_study_id>
    <nct_id>NCT04493242</nct_id>
  </id_info>
  <brief_title>Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS</brief_title>
  <acronym>EXIT-COVID19</acronym>
  <official_title>Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS): A Phase II Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Direct Biologics, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Direct Biologics, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and efficacy of intravenous administration of bone marrow derived&#xD;
      extracellular vesicles, ExoFlo, versus placebo as treatment for moderate-to-severe Acute&#xD;
      Respiratory Distress Syndrome (ARDS) in patients with severe COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase II, double-blinded, placebo-controlled, randomized controlled trial that&#xD;
      enrolled 102 subjects that were admitted with COVID-19 associated moderate-to-severe ARDS&#xD;
      across 6 sites in the United States.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 24, 2020</start_date>
  <completion_date type="Actual">May 22, 2021</completion_date>
  <primary_completion_date type="Actual">May 1, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Multi-center, double-blinded, placebo-controlled, randomized controlled trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Double-blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of 60-day Mortality Rate</measure>
    <time_frame>60 days</time_frame>
    <description>To evaluate the 60-day mortality rate for IP 15mL as a treatment for COVID-19 associated moderate to severe ARDS compared to placebo. Reducing the mortality rate for hospitalized patients with COVID-19 associated ARDS is a measure of the treatment effect.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival Rates</measure>
    <time_frame>Days 15, 30, 60</time_frame>
    <description>Reducing the mortality rate for hospitalized patients with COVID-19 associated ARDS is a measure of the treatment effect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Discharged Patients</measure>
    <time_frame>Days 7, 30, 60</time_frame>
    <description>Discharge is an unbiased measure of overall clinical improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Discharge</measure>
    <time_frame>Number of days from the date of randomization until documented discharge from hospital, up to 60 days.</time_frame>
    <description>Discharge is an unbiased measure of overall clinical improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment Emergent Serious Adverse Events</measure>
    <time_frame>61 days</time_frame>
    <description>Safety comparison performed between IP 15 mL and placebo arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilation Free Days</measure>
    <time_frame>Within 60 days of follow-up</time_frame>
    <description>Number of days for which patients are not on mechanical ventilation.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>COVID-19</condition>
  <condition>ARDS</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline 100 mL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Normal saline 90 mL and ExoFlo 10 mL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Normal saline 85 mL and ExoFlo 15 mL</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ExoFlo</intervention_name>
    <description>Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles</description>
    <arm_group_label>Experimental Dose 1</arm_group_label>
    <arm_group_label>Experimental Dose 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intravenous normal saline</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of signed and dated informed consent form (either by the individual or by&#xD;
             the individual's healthcare proxy).&#xD;
&#xD;
          2. Stated willingness to comply with all study procedures and availability for the&#xD;
             duration of the study&#xD;
&#xD;
          3. Male or female, aged 18-85.&#xD;
&#xD;
          4. COVID-19 positive as defined by positive Reverse Transcriptase Polymerase Chain&#xD;
             Reaction (RT-PCR) SARS-CoV-2.&#xD;
&#xD;
          5. Moderate to severe ARDS as defined by modified Berlin definition, * which includes&#xD;
             timing within 1 week of known clinical insult or new or worsening respiratory&#xD;
             symptoms; bilateral opacities not fully explained by effusions, or lung collapse;&#xD;
             respiratory failure not fully explained by cardiac failure or fluid overload;&#xD;
             PaO2/FiO2 ≤ 200 mm Hg.&#xD;
&#xD;
             *Modified Berlin definition used in this study is the full Berlin definition, albeit&#xD;
             without the PEEP specification, which implies mechanical ventilation.&#xD;
&#xD;
          6. Hypoxia requiring noninvasive oxygen support such as Nasal Cannula (NC), Nonrebreather&#xD;
             (NRB), Bilevel Positive Airway Pressure (BIPAP), Continuous Positive Airway Pressure&#xD;
             (CPAP), high flow nasal cannula oxygen (HFNC O2) or mechanical ventilation (MV)&#xD;
             despite initiating standard of care.&#xD;
&#xD;
          7. If the candidate is either a male or female of reproductive potential, he or she must&#xD;
             agree to use of double barrier method of highly effective birth control contraception&#xD;
             such as condoms with oral contraceptive pill or choose to remain abstinent if already&#xD;
             practicing abstinence during the screening period. The required duration of usage of&#xD;
             double barrier method OR maintenance of abstinence must include the time from the&#xD;
             beginning of the screening period until 90 days following the last dose of the study&#xD;
             treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Vulnerable populations such as pregnant patients, children, individuals with severe&#xD;
             physical or mental disabilities who cannot provide meaningful consent.&#xD;
&#xD;
          2. Active malignancy requiring treatment within the last five years.&#xD;
&#xD;
          3. Major physical trauma in the last 5 days, including motor vehicle accidents, assaults,&#xD;
             mechanical falls with sequelae of significant bleeding or craniofacial bruising, and&#xD;
             surgeries.&#xD;
&#xD;
          4. Active tuberculosis or cystic fibrosis.&#xD;
&#xD;
          5. Severe chronic respiratory disease including chronic obstructive pulmonary disease or&#xD;
             pulmonary fibrosis requiring home oxygen &gt; 5L/min.&#xD;
&#xD;
          6. Use of extracorporeal membrane oxygenation (ECMO) during the current hospitalization.&#xD;
&#xD;
          7. Pre-existing pulmonary hypertension.&#xD;
&#xD;
          8. Severe pre-existing hepatic impairment (presence of cirrhosis, liver function tests&#xD;
             (LFTs) ≥ 6x baseline, INR ≥ 2.0).&#xD;
&#xD;
          9. Pre-existing Chronic Kidney Disease (CKD) stage IIIb or End Stage Renal Disease (ESRD)&#xD;
             prior to onset of COVID-19 (stage I, II, and IIIa are acceptable)&#xD;
&#xD;
         10. Irreversible coagulopathy (e.g., frequently occluded vascular access despite&#xD;
             anticoagulation, precipitous platelet drops concurrent with end-organ damage&#xD;
             suggesting consumptive process) or irreversible bleeding disorder (e.g., frequent&#xD;
             bleeding from vascular access, endotracheal tubes, and foley).&#xD;
&#xD;
         11. Pneumonia clearly attributable to a non-COVID-19 related process, including aspiration&#xD;
             pneumonia or pneumonia that is exclusively bacterial, or originating from a diagnosed&#xD;
             alternative virus (e.g., influenza).&#xD;
&#xD;
         12. Patients who are not full code.&#xD;
&#xD;
         13. Endotracheal intubation duration ≤ 24 hours.&#xD;
&#xD;
         14. Moribund-expected survival &lt; 24 hours.&#xD;
&#xD;
         15. Severe metabolic disturbances on presentation (e.g., ketoacidosis, pH &lt; 7.3)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy Lightner, MD</last_name>
    <role>Study Director</role>
    <affiliation>Direct Biologics, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Helen Keller Hospital</name>
      <address>
        <city>Sheffield</city>
        <state>Alabama</state>
        <zip>35660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph Heritage Healthcare</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Donald Guthrie Foundation/ Robert Packer Hospital</name>
      <address>
        <city>Sayre</city>
        <state>Pennsylvania</state>
        <zip>18840</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hermann Memorial City Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Covenant Health System</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PRX Research</name>
      <address>
        <city>Mesquite</city>
        <state>Texas</state>
        <zip>75149</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://directbiologics.com/</url>
    <description>Direct Biologics, LLC</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <results_first_submitted>February 13, 2023</results_first_submitted>
  <results_first_submitted_qc>April 10, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 11, 2023</results_first_posted>
  <last_update_submitted>April 10, 2023</last_update_submitted>
  <last_update_submitted_qc>April 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>ARDS</keyword>
  <keyword>Extracellular Vesicles</keyword>
  <keyword>Exosome</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>February 8, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT04493242/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>September 17, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT04493242/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 121 subjects were screened and 102 subjects were enrolled in the study at 6 investigative sites in the United States from 24 SEP 2020 to 22 MAY 2021.</recruitment_details>
      <pre_assignment_details>Subjects that remained eligible per inclusion/exclusion criteria were randomized and equally distributed in the three study arms.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Experimental Dose 2</title>
          <description>Normal saline 85 mL and ExoFlo 15 mL&#xD;
ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles</description>
        </group>
        <group group_id="P2">
          <title>Experimental Dose 1</title>
          <description>Normal saline 90 mL and ExoFlo 10 mL&#xD;
ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Normal saline 100 mL&#xD;
Intravenous normal saline: Placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="34"/>
                <participants group_id="P3" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received 1 Dose Only</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received 2 Doses</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Subjects Who Did Not Receive a Full Dose at Any Dose (Dose 1 or 2)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subjects Discharged from Hospital Prior to End of Study</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subjects Whose Status as of the End of Study Was Unknown</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Safety Analysis Set consisted of all participants who received any study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Experimental Dose 2</title>
          <description>Normal saline 85 mL and ExoFlo 15 mL&#xD;
ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles</description>
        </group>
        <group group_id="B2">
          <title>Experimental Dose 1</title>
          <description>Normal saline 90 mL and ExoFlo 10 mL&#xD;
ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Normal saline 100 mL&#xD;
Intravenous normal saline: Placebo</description>
        </group>
        <group group_id="B4">
          <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="34"/>
            <count group_id="B2" value="34"/>
            <count group_id="B3" value="34"/>
            <count group_id="B4" value="102"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="34"/>
                    <count group_id="B2" value="34"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.8" spread="14.97"/>
                    <measurement group_id="B2" value="62.1" spread="13.47"/>
                    <measurement group_id="B3" value="58.5" spread="11.76"/>
                    <measurement group_id="B4" value="59.1" spread="13.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age ≥ 65</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="34"/>
                    <count group_id="B2" value="34"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age &lt; 65</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="34"/>
                    <count group_id="B2" value="34"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="70"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="34"/>
                    <count group_id="B2" value="34"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="67"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="34"/>
                    <count group_id="B2" value="34"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="78"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <description>Body Mass Index- used to classify different weight types:&#xD;
Underweight: Less than 18.5 Optimum range: 18.5 to 24.9 Overweight: 25 to 29.9 Class I obesity: 30 to 34.9 Class II obesity: 35 to 39.9 Class III obesity: More than 40</description>
          <population>Unknown BMI for one subject in Experimental Dose 2 arm.</population>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                    <count group_id="B2" value="34"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.98" spread="9.459"/>
                    <measurement group_id="B2" value="35.63" spread="10.939"/>
                    <measurement group_id="B3" value="34.24" spread="8.526"/>
                    <measurement group_id="B4" value="34.95" spread="9.615"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Respiratory Rate</title>
          <units>breaths/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="34"/>
                    <count group_id="B2" value="34"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.8" spread="5.38"/>
                    <measurement group_id="B2" value="24.4" spread="5.41"/>
                    <measurement group_id="B3" value="25.2" spread="7.90"/>
                    <measurement group_id="B4" value="24.5" spread="6.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Intubated Prior to Enrolling into the Study</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="34"/>
                    <count group_id="B2" value="34"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time from the First COVID-19 Diagnosis to the First IP Dose Date</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="34"/>
                    <count group_id="B2" value="34"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.0" spread="6.55"/>
                    <measurement group_id="B2" value="9.1" spread="4.36"/>
                    <measurement group_id="B3" value="9.5" spread="4.12"/>
                    <measurement group_id="B4" value="9.5" spread="5.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total SOFA Score</title>
          <description>Sequential Organ Failure Assessment Score- morbidity severity score and mortality estimation tool. The SOFA Score ranges from 0 to 24.&#xD;
SOFA Scores are used to estimate mortality risk. 0 to 6= &lt;10% Mortality 7 to 9 = 15-20% Mortality 10 to 12= 40-50% Mortality 13 to 14= 50-60% Mortality 15= &gt;80% Mortality 15 to 24= &gt;90% Mortality</description>
          <population>Unknown SOFA score for one subject in the placebo arm.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="34"/>
                    <count group_id="B2" value="34"/>
                    <count group_id="B3" value="33"/>
                    <count group_id="B4" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.2" spread="1.78"/>
                    <measurement group_id="B2" value="2.9" spread="1.20"/>
                    <measurement group_id="B3" value="3.2" spread="1.88"/>
                    <measurement group_id="B4" value="3.1" spread="1.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>P/F Ratio</title>
          <description>Partial Pressure of Arterial Oxygen to Fraction of Inspired Oxygen Ratio Hypoxemia: mild (200 mm Hg &lt; PaO2/FiO2 ≤ 300 mm Hg), moderate (100 mm Hg &lt; PaO2/FiO2 ≤ 300 mm Hg), and severe (PaO2/FiO2 ≤ 100 mm Hg)</description>
          <population>Unknown P/F Ratio data from 17 subjects in experimental dose 2, 15 subjects in experimental dose 1, and 16 subjects in placebo arms.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="17"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="18"/>
                    <count group_id="B4" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="115.202" spread="61.5299"/>
                    <measurement group_id="B2" value="113.824" spread="48.5386"/>
                    <measurement group_id="B3" value="102.952" spread="43.0002"/>
                    <measurement group_id="B4" value="110.634" spread="50.6610"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>P/F Ratio</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>P/F Ratio &lt; 100 mmHg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="34"/>
                    <count group_id="B2" value="34"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>P/F Ratio ≥ 100 mmHg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="34"/>
                    <count group_id="B2" value="34"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown P/F Ratio</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="34"/>
                    <count group_id="B2" value="34"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Therapy</title>
          <description>Started prior to the first dose of IP regardless of its end date.</description>
          <population>Measured for those subjects that started prior therapy prior to the first dose of IP.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Remdesivir</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="30"/>
                    <count group_id="B4" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Convalescent Plasma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="30"/>
                    <count group_id="B4" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dexamethasone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="30"/>
                    <count group_id="B4" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Evaluation of 60-day Mortality Rate</title>
        <description>To evaluate the 60-day mortality rate for IP 15mL as a treatment for COVID-19 associated moderate to severe ARDS compared to placebo. Reducing the mortality rate for hospitalized patients with COVID-19 associated ARDS is a measure of the treatment effect.</description>
        <time_frame>60 days</time_frame>
        <population>The Intention to Treat Analysis set consisted of all participants who received study drug. The number of subjects who died within 60 days is captured in the Outcome Measure Data Table.</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental Dose 2</title>
            <description>Normal saline 85 mL and ExoFlo 15 mL&#xD;
ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles</description>
          </group>
          <group group_id="O2">
            <title>Experimental Dose 1</title>
            <description>Normal saline 90 mL and ExoFlo 10 mL&#xD;
ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Normal saline 100 mL&#xD;
Intravenous normal saline: Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of 60-day Mortality Rate</title>
          <description>To evaluate the 60-day mortality rate for IP 15mL as a treatment for COVID-19 associated moderate to severe ARDS compared to placebo. Reducing the mortality rate for hospitalized patients with COVID-19 associated ARDS is a measure of the treatment effect.</description>
          <population>The Intention to Treat Analysis set consisted of all participants who received study drug. The number of subjects who died within 60 days is captured in the Outcome Measure Data Table.</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="34"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>log-rank test</non_inferiority_desc>
            <p_value>0.1343</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival Rates</title>
        <description>Reducing the mortality rate for hospitalized patients with COVID-19 associated ARDS is a measure of the treatment effect.</description>
        <time_frame>Days 15, 30, 60</time_frame>
        <population>The Intention to Treat Analysis set consisted of all participants who received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental Dose 2</title>
            <description>Normal saline 85 mL and ExoFlo 15 mL&#xD;
ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles</description>
          </group>
          <group group_id="O2">
            <title>Experimental Dose 1</title>
            <description>Normal saline 90 mL and ExoFlo 10 mL&#xD;
ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Normal saline 100 mL&#xD;
Intravenous normal saline: Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival Rates</title>
          <description>Reducing the mortality rate for hospitalized patients with COVID-19 associated ARDS is a measure of the treatment effect.</description>
          <population>The Intention to Treat Analysis set consisted of all participants who received study drug.</population>
          <units>Survival Percentage</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall Survival Rate at 15 Days (Kaplan-Meier Method)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.8"/>
                    <measurement group_id="O2" value="77.8"/>
                    <measurement group_id="O3" value="75.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Survival Rate at 30 Days (Kaplan-Meier Method)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.7"/>
                    <measurement group_id="O2" value="67.7"/>
                    <measurement group_id="O3" value="63.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Survival Rate at 60 Days (Kaplan-Meier Method)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.6"/>
                    <measurement group_id="O2" value="53.4"/>
                    <measurement group_id="O3" value="51.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Discharged Patients</title>
        <description>Discharge is an unbiased measure of overall clinical improvement.</description>
        <time_frame>Days 7, 30, 60</time_frame>
        <population>The Intention to Treat Analysis Set consisted of all participants who received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental Dose 2</title>
            <description>Normal saline 85 mL and ExoFlo 15 mL&#xD;
ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles</description>
          </group>
          <group group_id="O2">
            <title>Experimental Dose 1</title>
            <description>Normal saline 90 mL and ExoFlo 10 mL&#xD;
ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Normal saline 100 mL&#xD;
Intravenous normal saline: Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Discharged Patients</title>
          <description>Discharge is an unbiased measure of overall clinical improvement.</description>
          <population>The Intention to Treat Analysis Set consisted of all participants who received study drug.</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="34"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjects Who Discharged Within 7 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects Who Discharged Within 30 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects Who Discharged Within 60 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Discharge</title>
        <description>Discharge is an unbiased measure of overall clinical improvement.</description>
        <time_frame>Number of days from the date of randomization until documented discharge from hospital, up to 60 days.</time_frame>
        <population>Intention-to-Treat (ITT) Analysis set consists of all randomized patients. Patients were analyzed according to the randomized treatment arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental Dose 2</title>
            <description>Normal saline 85 mL and ExoFlo 15 mL&#xD;
ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles</description>
          </group>
          <group group_id="O2">
            <title>Experimental Dose 1</title>
            <description>Normal saline 90 mL and ExoFlo 10 mL&#xD;
ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Normal saline 100 mL&#xD;
Intravenous normal saline: Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Discharge</title>
          <description>Discharge is an unbiased measure of overall clinical improvement.</description>
          <population>Intention-to-Treat (ITT) Analysis set consists of all randomized patients. Patients were analyzed according to the randomized treatment arm.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22" lower_limit="6" upper_limit="NA">N/A: The upper 95% confidence interval cannot be estimated due to an insufficient number of discharged participants to estimate a standard error.</measurement>
                    <measurement group_id="O2" value="29" lower_limit="9" upper_limit="NA">N/A: The upper 95% confidence interval cannot be estimated due to an insufficient number of discharged participants to estimate a standard error.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="7" upper_limit="NA">Median was not reached due to an insufficient number of discharged patients. N/A: The upper 95% confidence interval cannot be estimated due to an insufficient number of discharged participants to estimate a standard error.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Treatment Emergent Serious Adverse Events</title>
        <description>Safety comparison performed between IP 15 mL and placebo arms</description>
        <time_frame>61 days</time_frame>
        <population>The Safety Analysis Set consisted of all participants who received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental Dose 2</title>
            <description>Normal saline 85 mL and ExoFlo 15 mL&#xD;
ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles</description>
          </group>
          <group group_id="O2">
            <title>Experimental Dose 1</title>
            <description>Normal saline 90 mL and ExoFlo 10 mL&#xD;
ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Normal saline 100 mL&#xD;
Intravenous normal saline: Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Treatment Emergent Serious Adverse Events</title>
          <description>Safety comparison performed between IP 15 mL and placebo arms</description>
          <population>The Safety Analysis Set consisted of all participants who received study drug.</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="34"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any TEAEs- Any Grade</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any TEAEs- Grade 3 or 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious TEAEs- Any Grade</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious TEAEs- Grade 3 or 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study Treatment-Related TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study Treatment-Related Serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAEs That Led to Dose Interruption</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAEs That Led to Missing Dose or Discontinued the Treatment Early</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAEs That Led to Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ventilation Free Days</title>
        <description>Number of days for which patients are not on mechanical ventilation.</description>
        <time_frame>Within 60 days of follow-up</time_frame>
        <population>The Intention to Treat Analysis set consisted of all participants who received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental Dose 2</title>
            <description>Normal saline 85 mL and ExoFlo 15 mL&#xD;
ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles</description>
          </group>
          <group group_id="O2">
            <title>Experimental Dose 1</title>
            <description>Normal saline 90 mL and ExoFlo 10 mL&#xD;
ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Normal saline 100 mL&#xD;
Intravenous normal saline: Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Ventilation Free Days</title>
          <description>Number of days for which patients are not on mechanical ventilation.</description>
          <population>The Intention to Treat Analysis set consisted of all participants who received study drug.</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="34"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.3" spread="25.78"/>
                    <measurement group_id="O2" value="32.0" spread="26.23"/>
                    <measurement group_id="O3" value="33.9" spread="28.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected within 60 days from the last dose.</time_frame>
      <desc>At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Experimental Dose 2</title>
          <description>Normal saline 85 mL and ExoFlo 15 mL&#xD;
ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles</description>
        </group>
        <group group_id="E2">
          <title>Experimental Dose 1</title>
          <description>Normal saline 90 mL and ExoFlo 10 mL&#xD;
ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Normal saline 100 mL&#xD;
Intravenous normal saline: Placebo</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="10" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Arteriospasm Coronary</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Ventricular Fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothermia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Multiple Organ Dysfunction Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Pneumonia Pseudomonal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal Chest Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Brain Oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Subarachnoid Hemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Renal Ischemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Renal Tubular Necrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Respiratory Failure</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="34"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="34"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Peripheral Arterial Occlusive Disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Peripheral Ischemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="25" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Anaemia Macrocytic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Blood Loss Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="34"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="34"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Macrocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Thrombocytosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Atrial Flutter</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Myocardial Ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Sinus Arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Sinus Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Sinus Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Ventricular Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Blood Glucose Increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Diabetes Mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Type 2 Diabetes Mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Ophthalmic Herpes Zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Colonic Abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Intestinal Perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Pharyngeal Haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Retroperitoneal Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Fluid Overload</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Generalised Oedema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="34"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="34"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Intensive Care Unit Acquired Weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Multiple Organ Dysfunction Syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Vitamin D Deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic Steatosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hepatobiliary Disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Jaundice Cholestatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Bacterial Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Candida Test Positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Enterococcal Bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Enterococcal Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Fungaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Gastroenteritis Escherichia Coli</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Oral Candidiasis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Pneumonia Staphylococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Staphylococcal Bacteraemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Staphylococcal Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Fungal Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection Enterococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Wound Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood Bilirubin Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Blood Creatinine Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Escherichia Test Positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Fibrin D Dimer Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hyperphosphataemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Klebsiella Test Positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Liver Function Test Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Morganella Test Positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Pseudomonas Test Positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Serratia Test Positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Stenotrophomonas Test Positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Transaminases Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Troponin I Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Metabolic Encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Adjustment Disorder with Depressed Mood</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="34"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Confusional State</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Mental Status Changes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Catheter Site Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Flank Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Urinary Incontinence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Endotracheal Intubation Complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Pneumomediastinum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Pulmonary Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Rales</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Subcutaneous Emphysema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Decubitus Ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Dry Skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Fungal Skin Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Skin Lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Skin Ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </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>Non-disclosure agreements with PIs in place. PIs cannot disclose data for approximately 10 years.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Amy Lightner</name_or_title>
      <organization>Direct Biologics, LLC</organization>
      <phone>512-354-7124</phone>
      <email>alightner@directbiologics.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/NCT04493242
org study id: DB-EF-PHASEII-001
nct id: NCT04493242
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
To evaluate the safety and efficacy of intravenous administration of bone marrow derived
      extracellular vesicles, ExoFlo, versus placebo as treatment for moderate-to-severe Acute
      Respiratory Distress Syndrome (ARDS) in patients with severe COVID-19.
This is a Phase II, double-blinded, placebo-controlled, randomized controlled trial that
      enrolled 102 subjects that were admitted with COVID-19 associated moderate-to-severe ARDS
      across 6 sites in the United States.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Multi-center, double-blinded, placebo-controlled, randomized controlled trial.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Double-blinded
measure: Evaluation of 60-day Mortality Rate
time frame: 60 days
description: To evaluate the 60-day mortality rate for IP 15mL as a treatment for COVID-19 associated moderate to severe ARDS compared to placebo. Reducing the mortality rate for hospitalized patients with COVID-19 associated ARDS is a measure of the treatment effect.
measure: Overall Survival Rates
time frame: Days 15, 30, 60
description: Reducing the mortality rate for hospitalized patients with COVID-19 associated ARDS is a measure of the treatment effect.
measure: Proportion of Discharged Patients
time frame: Days 7, 30, 60
description: Discharge is an unbiased measure of overall clinical improvement.
measure: Time to Discharge
time frame: Number of days from the date of randomization until documented discharge from hospital, up to 60 days.
description: Discharge is an unbiased measure of overall clinical improvement.
measure: Incidence of Treatment Emergent Serious Adverse Events
time frame: 61 days
description: Safety comparison performed between IP 15 mL and placebo arms
measure: Ventilation Free Days
time frame: Within 60 days of follow-up
description: Number of days for which patients are not on mechanical ventilation.
arm group label: Placebo
arm group type: Placebo Comparator
description: Normal saline 100 mL
arm group label: Experimental Dose 1
arm group type: Experimental
description: Normal saline 90 mL and ExoFlo 10 mL
arm group label: Experimental Dose 2
arm group type: Experimental
description: Normal saline 85 mL and ExoFlo 15 mL
intervention type: Biological
intervention name: ExoFlo
description: Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles
arm group label: Experimental Dose 1
arm group label: Experimental Dose 2
intervention type: Other
intervention name: Intravenous normal saline
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Amy Lightner, MD
role: Study Director
affiliation: Direct Biologics, LLC
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://directbiologics.com/
description: Direct Biologics, LLC
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: 