<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/NCT04401475</url>
  </required_header>
  <id_info>
    <org_study_id>EB05-04-2020</org_study_id>
    <nct_id>NCT04401475</nct_id>
  </id_info>
  <brief_title>A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB05 + SOC vs. Placebo + SOC in Adult Hospitalized Patients With COVID-19</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB05 + SOC vs. Placebo + SOC in Adult Hospitalized Patients With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Edesa Biotech Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>JSS Medical Research Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Edesa Biotech Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      COVID-19 patients who develop severe disease often develop acute respiratory distress&#xD;
      syndrome (ARDS) as a result of a dysregulated immune response. This in turn stimulates a&#xD;
      pro-inflammatory cascade (&quot;cytokine storm&quot;) as well as emergency myelopoiesis.&#xD;
&#xD;
      This proinflammatory cascade is activated when viral-mediated cell damage occurs in the&#xD;
      lungs, resulting in the release of damage-signaling alarmin molecules such as S100A8/A9&#xD;
      (Calprotectin), HMGB1, Resistin, and oxidized phospholipids. These damage-associated&#xD;
      molecular patterns (DAMPs) are recognized by the pattern recognition receptor Toll-Like&#xD;
      Receptor 4 (TLR4) found on macrophages, dendritic cells and other innate immune cells and&#xD;
      result in additional release of pro-inflammatory molecules. Several recent studies have shown&#xD;
      that S100A8/A9 serum levels in hospitalized COVID-19 patients positively correlate with both&#xD;
      neutrophil count and disease severity. Taken together the DAMP-TLR4 interaction forms a&#xD;
      central axis in the innate immune system and is a key driver of the pathological inflammation&#xD;
      observed in COVID-19. We hypothesis that targeting the initial step in the signalling&#xD;
      pathways of these DAMPs in innate immunity offers the best hope for controlling the&#xD;
      exaggerated host response to SARS-CoV-2 infection.&#xD;
&#xD;
      EB05 has demonstrated safety in two clinical studies (&gt;120 patients) and was able to block&#xD;
      LPS-induced (TLR4 agonist) IL-6 release in humans. Given, this extensive body of evidence we&#xD;
      believe EB05 could ameliorate ARDS due to COVID-19, significantly reducing ventilation rates&#xD;
      and mortality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 25, 2020</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>This is a multicenter, randomized, double-blind, placebo-controlled, study to evaluate the safety and efficacy of EB05 in adult hospitalized patients with COVID-19. Following enrollment in the study, eligible subjects will be randomized at a ratio of 1:1 at baseline to receive an infusion of either EB05 or Placebo. In addition to study treatment, all patients will receive SOC treatment per routine care at each participating site. Randomization is stratified by site and baseline WHO COVID-19 severity strata defined as Levels 3-4 and Levels 5-6 for the phase 2 study and Levels 6-7 for the phase 3 study.&#xD;
The total follow-up duration of each patient will be until 60-days from treatment with the investigational product. All assessments will take place in-hospital except for the 28-day and 60-day follow-up assessment which will be by telephone if the patient has been discharged before this assessment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality rate at Day 28 from IP administration.</measure>
    <time_frame>28 days</time_frame>
    <description>For the current study, the primary efficacy outcome measure will be the mortality rate from IP administration. Mortality is the most clinically relevant therapeutic endpoint for this population that is on IMV. The primary endpoint will be assessed at 28-days after treatment initiation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with clinical improvement at Day 28</measure>
    <time_frame>28 days</time_frame>
    <description>The proportion of patients with clinical improvement, defined as a decrease of two points or more on the World Health Organization (WHO) 9 - point ordinal scale at Day 28 from IP administration.&#xD;
The severity of COVID-19 disease is classified according to the WHO 9-point ordinal scale. The minimum value of 0 is associated with an &quot;uninfected&quot; stage wherein no clinical or virological evidence of infection is present. The maximum value of 8 is associated with death. A higher score reflects a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with clinical improvement at Day 60</measure>
    <time_frame>60 days</time_frame>
    <description>The proportion of patients with clinical improvement, defined as a decrease of two points or more on the World Health Organization (WHO) 9 - point ordinal scale at Day 60 from IP administration.&#xD;
The severity of COVID-19 disease is classified according to the WHO 9-point ordinal scale. The minimum value of 0 is associated with an &quot;uninfected&quot; stage wherein no clinical or virological evidence of infection is present. The maximum value of 8 is associated with death. A higher score reflects a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate at Day 60</measure>
    <time_frame>60 days</time_frame>
    <description>The mortality rate at Day 60 from IP administration.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of treatment-emergent adverse events (TEAEs) and serious TEAEs.</measure>
    <time_frame>28 and 60 days</time_frame>
    <description>Safety Endpoint: Number of treatment-emergent adverse events (TEAEs) and serious TEAEs.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">644</enrollment>
  <condition>COVID-19</condition>
  <condition>ARDS</condition>
  <arm_group>
    <arm_group_label>Stage 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stage 1 (Phase II Study) For 80% power (β = 0.20), at a significance level of 5% (α =0.05) and a 1:1 randomization ratio, a total of 316 (EB05: 158, SOC: 158) evaluable patients will be required. Allowing for 20% attrition a total of 396 patients will be recruited.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stage 2 (Phase III Study) For a 1:1 ratio of patients treated with EB05 vs. Placebo, a cumulative one-sided alpha of 2.5% and 90% power, to detect an Odds Ratio of 2.00, a total of 586 evaluable patients will be required for Stage 2 (Phase III study). 293 of these will be treated with EB05 + SOC and 293 treated with Placebo + SOC. Allowing for 10% attrition, a total of 644 patients will be enrolled in this Stage.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>SOC plus 15mg/kg EB05 IV</intervention_name>
    <description>Standard of care plus single IV infusion of 15mg/kg of EB05.</description>
    <arm_group_label>Stage 1</arm_group_label>
    <arm_group_label>Stage 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SOC plus Placebo IV</intervention_name>
    <description>Standard of care plus a single IV infusion of placebo.</description>
    <arm_group_label>Stage 1</arm_group_label>
    <arm_group_label>Stage 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women ≥18 years of age at the time of consent.&#xD;
&#xD;
          2. Laboratory-confirmed diagnosis of COVID-19.&#xD;
&#xD;
          3. Hospitalized for COVID-19 related respiratory disease.&#xD;
&#xD;
          4. Patient belongs to one of the following two categories in the nine-point COVID-19&#xD;
             severity scale:&#xD;
&#xD;
               1. Hospitalized, requiring intubation and mechanical ventilation - Level 6 of the&#xD;
                  nine-point COVID-19 severity scale.&#xD;
&#xD;
               2. Hospitalized and intubated with additional organ support - pressors, RRT, ECMO -&#xD;
                  Level 7 of the nine-point COVID-19 severity scale.&#xD;
&#xD;
          5. For women of childbearing potential involved in any sexual intercourse that could lead&#xD;
             to pregnancy: Negative pregnancy test and willingness to use contraceptive (consistent&#xD;
             with local regulations) during the study period.&#xD;
&#xD;
          6. Signed informed consent obtained by any patient capable of giving consent, or, when&#xD;
             the patient is not capable of giving consent, from his or her legal/authorized&#xD;
             representatives.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The subject is a female who is breastfeeding or pregnant.&#xD;
&#xD;
          2. Known hypersensitivity to EB05 or its excipients.&#xD;
&#xD;
          3. In the opinion of the investigator, death is imminent and inevitable or patient will&#xD;
             be discharged within the next 48 - 72 hours, irrespective of the provision of&#xD;
             treatment.&#xD;
&#xD;
          4. Experiencing cardiac arrest while hospitalized with COVID-19.&#xD;
&#xD;
          5. Active participation in other immunomodulator or immunosuppressant drug clinical&#xD;
             trials.&#xD;
&#xD;
             a. Participation in COVID-19 antiviral, anticoagulant and convalescent plasma trials&#xD;
             may be permitted; however, the decision to enroll a patient who is participating in&#xD;
             other clinical trials will be dealt with on a case-by-case basis.&#xD;
&#xD;
          6. Treatment with immunomodulator or immunosuppressant drugs, including but not limited&#xD;
             to TNF inhibitors and anti-IL-1 agents within 5 half-lives or 30 days (whichever is&#xD;
             longer) before randomization. Except for the following, which are permitted:&#xD;
&#xD;
               1. Treatment with immunomodulator, or immunosuppressant drugs, such as&#xD;
                  corticosteroids, as part of SOC for COVID-19&#xD;
&#xD;
               2. Transplant patients&#xD;
&#xD;
          7. Known other clinical conditions that contraindicate EB05 and cannot be treated or&#xD;
             solved according to the judgment of the clinician.&#xD;
&#xD;
          8. Patient has been intubated or mechanically ventilated for more than 72 hours prior to&#xD;
             administration of the investigational product.&#xD;
&#xD;
          9. Patient has been intubated and then extubated during the current hospitalization prior&#xD;
             to administration of the investigational product.&#xD;
&#xD;
         10. Patient has experienced meaningful clinical improvement in the severity of disease&#xD;
             prior to administration of the investigational product.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Blair Gordon, PhD</last_name>
    <phone>289-800-9600</phone>
    <phone_ext>140</phone_ext>
    <email>info@edesabiotech.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>UCSF Fresno</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>St. Jude Medical Center/ Providence</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Miami Hospital</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33146</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Baystate Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01199</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wayne State University</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Providence Portland Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>West Virginia University Medicine Heart &amp; Vascular Institute</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506-6224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Alberta Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Vancouver Coastal Health</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5K 1Z9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Vancouver General Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>William Osler Health System</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <zip>L6R 3J7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Markham Stouffville Hospital</name>
      <address>
        <city>Markham</city>
        <state>Ontario</state>
        <zip>L3P 7P3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Southlake Regional Health Centre</name>
      <address>
        <city>Newmarket</city>
        <state>Ontario</state>
        <zip>L3Y 2P9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Lakeridge Health</name>
      <address>
        <city>Oshawa</city>
        <state>Ontario</state>
        <zip>L1G 2B9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital Research Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Toronto General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CISS Monteregie-Centre</name>
      <address>
        <city>Greenfield Park</city>
        <state>Quebec</state>
        <zip>J4V 2H2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital Maisonneuve Rosemont</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital Régional de Rimouski</name>
      <address>
        <city>Rimouski</city>
        <state>Quebec</state>
        <zip>G5L 5T1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Colombia</country>
  </removed_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>July 28, 2023</last_update_submitted>
  <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TLR4</keyword>
  <keyword>ARDS</keyword>
  <keyword>COVID-19</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>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04401475
org study id: EB05-04-2020
nct id: NCT04401475
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
COVID-19 patients who develop severe disease often develop acute respiratory distress
      syndrome (ARDS) as a result of a dysregulated immune response. This in turn stimulates a
      pro-inflammatory cascade ("cytokine storm") as well as emergency myelopoiesis.

      This proinflammatory cascade is activated when viral-mediated cell damage occurs in the
      lungs, resulting in the release of damage-signaling alarmin molecules such as S100A8/A9
      (Calprotectin), HMGB1, Resistin, and oxidized phospholipids. These damage-associated
      molecular patterns (DAMPs) are recognized by the pattern recognition receptor Toll-Like
      Receptor 4 (TLR4) found on macrophages, dendritic cells and other innate immune cells and
      result in additional release of pro-inflammatory molecules. Several recent studies have shown
      that S100A8/A9 serum levels in hospitalized COVID-19 patients positively correlate with both
      neutrophil count and disease severity. Taken together the DAMP-TLR4 interaction forms a
      central axis in the innate immune system and is a key driver of the pathological inflammation
      observed in COVID-19. We hypothesis that targeting the initial step in the signalling
      pathways of these DAMPs in innate immunity offers the best hope for controlling the
      exaggerated host response to SARS-CoV-2 infection.

      EB05 has demonstrated safety in two clinical studies (>120 patients) and was able to block
      LPS-induced (TLR4 agonist) IL-6 release in humans. Given, this extensive body of evidence we
      believe EB05 could ameliorate ARDS due to COVID-19, significantly reducing ventilation rates
      and mortality.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: This is a multicenter, randomized, double-blind, placebo-controlled, study to evaluate the safety and efficacy of EB05 in adult hospitalized patients with COVID-19. Following enrollment in the study, eligible subjects will be randomized at a ratio of 1:1 at baseline to receive an infusion of either EB05 or Placebo. In addition to study treatment, all patients will receive SOC treatment per routine care at each participating site. Randomization is stratified by site and baseline WHO COVID-19 severity strata defined as Levels 3-4 and Levels 5-6 for the phase 2 study and Levels 6-7 for the phase 3 study.
The total follow-up duration of each patient will be until 60-days from treatment with the investigational product. All assessments will take place in-hospital except for the 28-day and 60-day follow-up assessment which will be by telephone if the patient has been discharged before this assessment.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Mortality rate at Day 28 from IP administration.
time frame: 28 days
description: For the current study, the primary efficacy outcome measure will be the mortality rate from IP administration. Mortality is the most clinically relevant therapeutic endpoint for this population that is on IMV. The primary endpoint will be assessed at 28-days after treatment initiation.
measure: Proportion of patients with clinical improvement at Day 28
time frame: 28 days
description: The proportion of patients with clinical improvement, defined as a decrease of two points or more on the World Health Organization (WHO) 9 - point ordinal scale at Day 28 from IP administration.
The severity of COVID-19 disease is classified according to the WHO 9-point ordinal scale. The minimum value of 0 is associated with an "uninfected" stage wherein no clinical or virological evidence of infection is present. The maximum value of 8 is associated with death. A higher score reflects a worse outcome.
measure: Proportion of patients with clinical improvement at Day 60
time frame: 60 days
description: The proportion of patients with clinical improvement, defined as a decrease of two points or more on the World Health Organization (WHO) 9 - point ordinal scale at Day 60 from IP administration.
The severity of COVID-19 disease is classified according to the WHO 9-point ordinal scale. The minimum value of 0 is associated with an "uninfected" stage wherein no clinical or virological evidence of infection is present. The maximum value of 8 is associated with death. A higher score reflects a worse outcome.
measure: Mortality rate at Day 60
time frame: 60 days
description: The mortality rate at Day 60 from IP administration.
measure: Number of treatment-emergent adverse events (TEAEs) and serious TEAEs.
time frame: 28 and 60 days
description: Safety Endpoint: Number of treatment-emergent adverse events (TEAEs) and serious TEAEs.
arm group label: Stage 1
arm group type: Experimental
description: Stage 1 (Phase II Study) For 80% power (β = 0.20), at a significance level of 5% (α =0.05) and a 1:1 randomization ratio, a total of 316 (EB05: 158, SOC: 158) evaluable patients will be required. Allowing for 20% attrition a total of 396 patients will be recruited.
arm group label: Stage 2
arm group type: Experimental
description: Stage 2 (Phase III Study) For a 1:1 ratio of patients treated with EB05 vs. Placebo, a cumulative one-sided alpha of 2.5% and 90% power, to detect an Odds Ratio of 2.00, a total of 586 evaluable patients will be required for Stage 2 (Phase III study). 293 of these will be treated with EB05 + SOC and 293 treated with Placebo + SOC. Allowing for 10% attrition, a total of 644 patients will be enrolled in this Stage.
intervention type: Biological
intervention name: SOC plus 15mg/kg EB05 IV
description: Standard of care plus single IV infusion of 15mg/kg of EB05.
arm group label: Stage 1
arm group label: Stage 2
intervention type: Other
intervention name: SOC plus Placebo IV
description: Standard of care plus a single IV infusion of placebo.
arm group label: Stage 1
arm group label: Stage 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Blair Gordon, PhD
phone: 289-800-9600
phone ext: 140
email: info@edesabiotech.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Canada
country: United States
country: Colombia
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided