<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/NCT04417257</url>
  </required_header>
  <id_info>
    <org_study_id>LAU-20-01</org_study_id>
    <nct_id>NCT04417257</nct_id>
  </id_info>
  <brief_title>Study of LAU-7b for the Treatment of COVID-19 Disease in Adults</brief_title>
  <acronym>RESOLUTION</acronym>
  <official_title>RESOLUTION: A Double-blind, Randomized, Placebo-controlled, Phase II/III Study of the Efficacy and Safety of LAU-7b in the Treatment of Adult Hospitalized Patients With COVID-19 Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laurent Pharmaceuticals Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laurent Pharmaceuticals 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized, double-blind, placebo-controlled Phase 2/3 Study of LAU-7b against confirmed&#xD;
      COVID-19 Disease in hospitalized patients at a higher risk of complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      RESOLUTION is a multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study of&#xD;
      LAU-7b for the treatment of COVID-19 Disease in patients at a higher risk than the general&#xD;
      COVID-19 Disease population to develop complications while hospitalized.&#xD;
&#xD;
      The goal of the study is to evaluate the efficacy of LAU-7b therapy + standard-of-care&#xD;
      relative to placebo + standard-of-care in patients with COVID-19 Disease with confirmed&#xD;
      SARS-CoV-2 infection.&#xD;
&#xD;
      The purpose of the treatment with LAU-7b is to prevent the worsening of the health of&#xD;
      hospitalized patients including aggravation such as recourse to mechanical ventilation and&#xD;
      death.&#xD;
&#xD;
      The means are the direct effects of LAU-7b on the resolution of inflammation, interference&#xD;
      with viral proliferation and protection from excessive pro-inflammatory response.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Double-blind, randomized, parallel groups and placebo-controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Patients will be randomly assigned to take either the active drug (LAU-7b capsule) or a matching inactive placebo (inactive capsule)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of patients requiring mechanical ventilation and/or deceased (all causes) by Day 60 (Ordinal scale scores 6-7 inclusively)</measure>
    <time_frame>From baseline to Day 60</time_frame>
    <description>This will be assessed through health status scoring using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score.&#xD;
Not hospitalized, no limitations on activities;&#xD;
Not hospitalized, limitation on activities;&#xD;
Hospitalized, not requiring supplemental oxygen;&#xD;
Hospitalized, requiring supplemental oxygen;&#xD;
Hospitalized, on non-invasive ventilation or high flow oxygen devices;&#xD;
Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation;&#xD;
Death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The safety of LAU-7b therapy will be assessed through the monitoring of treatment emergent adverse events, compared to placebo</measure>
    <time_frame>From baseline to Day 60</time_frame>
    <description>This will be assessed through monitoring and probing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of all-causes death, depicted by a change from baseline in the Ordinal Scale score to category 7</measure>
    <time_frame>On Days 29 and 60</time_frame>
    <description>This will be assessed through Day 60 health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of COVID-19 disease-related transfer to mechanical ventilation or ECMO, depicted by a change from baseline in the ordinal scale score to category 6, compared to placebo</measure>
    <time_frame>From baseline to Day 60</time_frame>
    <description>This will be assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients alive and free of respiratory failure by Day 29 (ordinal scale scores 1-4, inclusively)</measure>
    <time_frame>On Day 29</time_frame>
    <description>This will be assessed by Day 29 health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of COVID-19 disease-related aggravation, depicted by a change from baseline in the ordinal scale score of at least one category, compared to placebo</measure>
    <time_frame>From baseline to Day 60</time_frame>
    <description>This will be assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of COVID-19 disease-related transfer to intensive care unit, depicted by a change from baseline in the ordinal scale score to categories 5 or 6, compared to placebo</measure>
    <time_frame>From baseline to Day 60</time_frame>
    <description>This will be assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health status of the patient on the 7-point Ordinal Scale compared to placebo</measure>
    <time_frame>On Days 14 and 29</time_frame>
    <description>This will be assessed through health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline of the ordinal scale patient health status as a function of assessment time, compared to placebo</measure>
    <time_frame>From baseline to Day 60</time_frame>
    <description>This will be assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to an improvement of one category on the ordinal scale patient health status, compared to placebo</measure>
    <time_frame>From baseline to Day 60</time_frame>
    <description>This will be assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to recovery, defined here as the time to reach categories 2 or 1 on the ordinal scale patient health status (first occurrence if more than once), compared to placebo</measure>
    <time_frame>From baseline to Day 60</time_frame>
    <description>This will be assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to mechanical ventilation, defined here as time to reach category 6 on the ordinal scale patient health status, compared to placebo</measure>
    <time_frame>From baseline to Day 60</time_frame>
    <description>This will be assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to death, defined here as a time to reach category 7 on the ordinal scale patient health status, censored to Day 29 if it happens later than Day 29, compared to placebo</measure>
    <time_frame>From baseline to Day 60</time_frame>
    <description>This will be assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospitalization (days) within the study period Days 1-60, compared to placebo</measure>
    <time_frame>From baseline to Day 60</time_frame>
    <description>Monitoring of the hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change from baseline in the score obtained on the EQ-5D-5L quality-of-life survey</measure>
    <time_frame>On Days 1, 14, 29, 45 and 60</time_frame>
    <description>This will be assessed through questionnaire filling, in person or remotely</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">508</enrollment>
  <condition>COVID-19 Disease</condition>
  <arm_group>
    <arm_group_label>LAU-7b</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active drug as LAU-7b capsules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo oral capsule (as inactive capsules identical to active arm)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LAU-7b</intervention_name>
    <description>LAU-7b will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.</description>
    <arm_group_label>LAU-7b</arm_group_label>
    <other_name>fenretinide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral capsule</intervention_name>
    <description>Placebo will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects must exhibit symptoms (including at least one lower respiratory symptom such&#xD;
             as shortness of breath or dyspnea) of COVID-19 disease at screening and/or since the&#xD;
             start of their hospitalization (may include treated symptoms;&#xD;
&#xD;
          2. Subjects must be 18 years and older, of either gender;&#xD;
&#xD;
          3. Subjects must have at least one of the following factors/co-morbidities:&#xD;
&#xD;
               1. Controlled or uncontrolled diabetes;&#xD;
&#xD;
               2. Pre-existing cardiovascular disease, including hypertension;&#xD;
&#xD;
               3. Pre-existing respiratory disease such as COPD, asthma, emphysema;&#xD;
&#xD;
               4. Active or a former smoker with a 20 pack-years of smoking history;&#xD;
&#xD;
               5. Obesity as depicted by body mass index ≥ 30;&#xD;
&#xD;
               6. Laboratory tests indicative of a higher risk of COVID-19-related complications,&#xD;
                  such as troponin &gt;1.5 upper limit of normal, D-dimer &gt;3.0 upper limit of normal&#xD;
                  and/or CRP &gt;1.5 upper limit of normal&#xD;
&#xD;
               7. Patient aged 70 years and older who, based on the judgment of the Investigator,&#xD;
                  is at a higher risk of developing complications.&#xD;
&#xD;
          4. Subjects must have a documented positive test for the SARS-CoV-2 virus;&#xD;
&#xD;
          5. Subjects must be under observation by, or admitted to a controlled facility or&#xD;
             hospital to receive standard-of-care for COVID-19 disease (care for COVID-19 disease&#xD;
             should be for no more than 72 hours before screening, including any prior stay in&#xD;
             another hospital);&#xD;
&#xD;
          6. Subject's health status must be 3 or 4 on the ordinal scale, and not previously a &quot;5&#xD;
             or a 6&quot;;&#xD;
&#xD;
          7. If female, must be either post-menopausal (one year or greater without menses),&#xD;
             surgically sterile, or, for female subjects of child-bearing potential who are capable&#xD;
             of conception, must be: practicing a highly effective method of birth control&#xD;
             (acceptable methods include intrauterine device, complete abstinence, spermicide +&#xD;
             barrier, male partner surgical sterilization, or hormonal contraception) during the&#xD;
             study and through 30 days after the last dose of the study medication. Periodical&#xD;
             abstinence is not classified as an effective method of birth control. A pregnancy test&#xD;
             must be negative at the Screening Visit;&#xD;
&#xD;
          8. Subjects must have the ability to understand and give informed consent, which can be&#xD;
             verbal with a witness, according to local requirements;&#xD;
&#xD;
          9. Subjects deemed capable of adequate compliance including attending scheduled visits&#xD;
             for the duration of the study;&#xD;
&#xD;
         10. Subjects must be able to swallow the study drug capsules.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy or breastfeeding;&#xD;
&#xD;
          2. Health condition deemed to possibly interfere with the study endpoints and/or the&#xD;
             safety of the patients. For example, the following conditions should be considered&#xD;
             contraindicated for participation in the study, but this is not an exhaustive list. In&#xD;
             case of doubt, the Investigator should consult with the sponsor's medical&#xD;
             representative:&#xD;
&#xD;
               1. Presence of inherited retinitis pigmentosa;&#xD;
&#xD;
               2. Presence or history of liver failure (Child-Pugh B or C);&#xD;
&#xD;
               3. Presence or history of stage 4 severe chronic kidney disease or dialysis&#xD;
                  requirement;&#xD;
&#xD;
               4. Febrile neutropenia;&#xD;
&#xD;
               5. Presence of end-stage cancer.&#xD;
&#xD;
          3. Known history of a severe allergy or sensitivity to retinoids, or with known allergies&#xD;
             to excipients in the oral capsule formulation proposed to be used in the study;&#xD;
&#xD;
          4. Participation in another drug clinical trial within 30 days (or a minimum of 5&#xD;
             elimination half-lives) prior to screening, except ongoing participation in&#xD;
             non-interventional studies;&#xD;
&#xD;
          5. Calculated creatinine clearance (CrCL, using the Cockroft-Gault equation for example)&#xD;
             &lt;50 ml/min;&#xD;
&#xD;
          6. Presence of total bilirubin &gt;1.5 x ULN (in the absence of demonstrated Gilbert's&#xD;
             syndrome), ALT and/or AST &gt; 2.5 x ULN;&#xD;
&#xD;
          7. Patient expected to be transferred to ICU or die in the next 24 hours.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Marie Houle, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Laurent Pharmaceuticals Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jean-Marie Houle, PhD</last_name>
    <phone>514-941-2313</phone>
    <email>jmhoule@laurentpharma.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Radu Pislariu, MD</last_name>
    <phone>514-513-2252</phone>
    <email>rpislariu@laurentpharma.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chandler Regional Medical Center / Mercy Gilbert Medical Center</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Annette Taylor, RN BsN CCRC</last_name>
      <phone>480-728-5721</phone>
    </contact>
    <contact_backup>
      <last_name>Jennine Zumbuhl, RN</last_name>
    </contact_backup>
    <investigator>
      <last_name>Brian Tiffany, MD PhD FACEP</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hoag Memorial Hospital Presbyterian</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julie Nguyen, CRC</last_name>
      <phone>949-764-6271</phone>
    </contact>
    <contact_backup>
      <last_name>Patrice Jones, CCRC</last_name>
    </contact_backup>
    <investigator>
      <last_name>Philip Robinson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of California Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erin Hardy</last_name>
      <phone>916-734-3866</phone>
    </contact>
    <investigator>
      <last_name>Brian Morrissey, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nuvance Health - Danbury Hospital</name>
      <address>
        <city>Danbury</city>
        <state>Connecticut</state>
        <zip>06810</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dawn Marie Morsey</last_name>
      <phone>203-739-6019</phone>
    </contact>
    <investigator>
      <last_name>Paul Nee, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MedStar Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Theresa Moriarty</last_name>
      <phone>202-877-3657</phone>
    </contact>
    <contact_backup>
      <last_name>Juan Carlos Silva</last_name>
    </contact_backup>
    <investigator>
      <last_name>Glenn Wortmann, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Baptist Medical Center Beaches</name>
      <address>
        <city>Jacksonville Beach</city>
        <state>Florida</state>
        <zip>32250</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>St Lukes Hospital</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83702</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lejla Godusevic, BSc</last_name>
      <phone>208-381-4717</phone>
    </contact>
    <contact_backup>
      <last_name>Dixie Durham, MHS RRT</last_name>
    </contact_backup>
    <investigator>
      <last_name>Karen S Miller, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NorthShore University Health System - Swedish Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60625</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jignesh Patel</last_name>
      <phone>224-364-7971</phone>
    </contact>
    <investigator>
      <last_name>Nirav Shah, MD MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NorthShore University Health System - Glenbrook Hospital</name>
      <address>
        <city>Glenview</city>
        <state>Illinois</state>
        <zip>60026</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tovah Klein</last_name>
    </contact>
    <contact_backup>
      <last_name>Jignesh Patel</last_name>
      <phone>224-364-7971</phone>
    </contact_backup>
    <investigator>
      <last_name>Nirav Shah, MD MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Oluwadamilola Adeyemi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kimberly Sprenger, RN BS</last_name>
      <phone>319-353-8862</phone>
    </contact>
    <investigator>
      <last_name>Alejandro Comellas, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Anne Arundel Medical Center, 2001 Medical Parkway, Belcher Pavillion</name>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <zip>21401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jaci Miller</last_name>
      <phone>443-481-5738</phone>
    </contact>
    <investigator>
      <last_name>Barry R Meisenberg, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wayne State University, Harper University Hospital and Detroit Receiving Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University Medical Center of Southern Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Bimbi</last_name>
      <phone>702-383-7302</phone>
    </contact>
    <investigator>
      <last_name>Shadaba Asad, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Staten Island University Hospital North</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amanda Tice</last_name>
      <phone>718-226-6454</phone>
    </contact>
    <investigator>
      <last_name>Barry Hahn, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Science</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yolanda Belin</last_name>
      <phone>615-752-7230</phone>
    </contact>
    <investigator>
      <last_name>Caryn Morse, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>OhioHealth Riverside Methodist Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Kettering Health</name>
      <address>
        <city>Kettering</city>
        <state>Ohio</state>
        <zip>45429</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Allison Dymacek</last_name>
    </contact>
    <investigator>
      <last_name>Jeffrey Weinstein, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hemant Shah, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Robert Packer Hospital</name>
      <address>
        <city>Sayre</city>
        <state>Pennsylvania</state>
        <zip>18840</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Donna Tyburczy</last_name>
      <phone>570-887-6071</phone>
    </contact>
    <contact_backup>
      <last_name>Jennifer Panek</last_name>
    </contact_backup>
    <investigator>
      <last_name>James Walsh, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tianna Petersen</last_name>
      <phone>214-648-5854</phone>
    </contact>
    <investigator>
      <last_name>Mamta K Jain, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>PRX Research /Dallas Regional Medical Center</name>
      <address>
        <city>Mesquite</city>
        <state>Texas</state>
        <zip>75149</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Utah Health</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Macy Barrios</last_name>
      <phone>801-581-5811</phone>
    </contact>
    <investigator>
      <last_name>Estelle Harris, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre d'études cliniques CIUSS SLJ, Hôpital Chicoutimi</name>
      <address>
        <city>Chicoutimi</city>
        <state>Quebec</state>
        <zip>G7H 5H6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>CIUSSSS de l'Est-de-l'Ile-de-Montréal, Hôpital Maisonneuve-Rosemont</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Université de Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2X2P1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Active, not 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>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>CISSS Des Laurentides</name>
      <address>
        <city>Saint-Jérôme</city>
        <state>Quebec</state>
        <zip>J7Z 5T3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>August 10, 2023</last_update_submitted>
  <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inflammation</keyword>
  <keyword>Antiviral</keyword>
  <keyword>Host-directed treatment</keyword>
  <keyword>Docosahexaenoic acid</keyword>
  <keyword>Pro-resolving</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fenretinide</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04417257
org study id: LAU-20-01
nct id: NCT04417257
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
A randomized, double-blind, placebo-controlled Phase 2/3 Study of LAU-7b against confirmed
      COVID-19 Disease in hospitalized patients at a higher risk of complications.
RESOLUTION is a multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study of
      LAU-7b for the treatment of COVID-19 Disease in patients at a higher risk than the general
      COVID-19 Disease population to develop complications while hospitalized.

      The goal of the study is to evaluate the efficacy of LAU-7b therapy + standard-of-care
      relative to placebo + standard-of-care in patients with COVID-19 Disease with confirmed
      SARS-CoV-2 infection.

      The purpose of the treatment with LAU-7b is to prevent the worsening of the health of
      hospitalized patients including aggravation such as recourse to mechanical ventilation and
      death.

      The means are the direct effects of LAU-7b on the resolution of inflammation, interference
      with viral proliferation and protection from excessive pro-inflammatory response.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double-blind, randomized, parallel groups and placebo-controlled trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Patients will be randomly assigned to take either the active drug (LAU-7b capsule) or a matching inactive placebo (inactive capsule)
measure: The proportion of patients requiring mechanical ventilation and/or deceased (all causes) by Day 60 (Ordinal scale scores 6-7 inclusively)
time frame: From baseline to Day 60
description: This will be assessed through health status scoring using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score.
Not hospitalized, no limitations on activities;
Not hospitalized, limitation on activities;
Hospitalized, not requiring supplemental oxygen;
Hospitalized, requiring supplemental oxygen;
Hospitalized, on non-invasive ventilation or high flow oxygen devices;
Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation;
Death.
measure: The safety of LAU-7b therapy will be assessed through the monitoring of treatment emergent adverse events, compared to placebo
time frame: From baseline to Day 60
description: This will be assessed through monitoring and probing
measure: Rate of all-causes death, depicted by a change from baseline in the Ordinal Scale score to category 7
time frame: On Days 29 and 60
description: This will be assessed through Day 60 health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.
measure: Rate of COVID-19 disease-related transfer to mechanical ventilation or ECMO, depicted by a change from baseline in the ordinal scale score to category 6, compared to placebo
time frame: From baseline to Day 60
description: This will be assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.
measure: Proportion of patients alive and free of respiratory failure by Day 29 (ordinal scale scores 1-4, inclusively)
time frame: On Day 29
description: This will be assessed by Day 29 health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.
measure: Rate of COVID-19 disease-related aggravation, depicted by a change from baseline in the ordinal scale score of at least one category, compared to placebo
time frame: From baseline to Day 60
description: This will be assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.
measure: Rate of COVID-19 disease-related transfer to intensive care unit, depicted by a change from baseline in the ordinal scale score to categories 5 or 6, compared to placebo
time frame: From baseline to Day 60
description: This will be assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.
measure: Health status of the patient on the 7-point Ordinal Scale compared to placebo
time frame: On Days 14 and 29
description: This will be assessed through health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.
measure: Mean change from baseline of the ordinal scale patient health status as a function of assessment time, compared to placebo
time frame: From baseline to Day 60
description: This will be assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.
measure: Time to an improvement of one category on the ordinal scale patient health status, compared to placebo
time frame: From baseline to Day 60
description: This will be assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.
measure: Time to recovery, defined here as the time to reach categories 2 or 1 on the ordinal scale patient health status (first occurrence if more than once), compared to placebo
time frame: From baseline to Day 60
description: This will be assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.
measure: Time to mechanical ventilation, defined here as time to reach category 6 on the ordinal scale patient health status, compared to placebo
time frame: From baseline to Day 60
description: This will be assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.
measure: Time to death, defined here as a time to reach category 7 on the ordinal scale patient health status, censored to Day 29 if it happens later than Day 29, compared to placebo
time frame: From baseline to Day 60
description: This will be assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (shown with the primary outcome measure), a higher score is worse than a low score.
measure: Duration of hospitalization (days) within the study period Days 1-60, compared to placebo
time frame: From baseline to Day 60
description: Monitoring of the hospitalization
measure: The change from baseline in the score obtained on the EQ-5D-5L quality-of-life survey
time frame: On Days 1, 14, 29, 45 and 60
description: This will be assessed through questionnaire filling, in person or remotely
arm group label: LAU-7b
arm group type: Experimental
description: Active drug as LAU-7b capsules
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo oral capsule (as inactive capsules identical to active arm)
intervention type: Drug
intervention name: LAU-7b
description: LAU-7b will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
arm group label: LAU-7b
other name: fenretinide
intervention type: Drug
intervention name: Placebo oral capsule
description: Placebo will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Marie Houle, PhD
role: Study Director
affiliation: Laurent Pharmaceuticals Inc.
last name: Jean-Marie Houle, PhD
phone: 514-941-2313
email: jmhoule@laurentpharma.com
last name: Radu Pislariu, MD
phone: 514-513-2252
email: rpislariu@laurentpharma.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Completed
country: Canada
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Fenretinide