xml: <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/NCT05999435</url>
    </required_header>
    <id_info>
      <org_study_id>LAU-23-01</org_study_id>
      <nct_id>NCT05999435</nct_id>
    </id_info>
    <brief_title>Study of LAU-7b for the Treatment of Long COVID in Adults</brief_title>
    <acronym>ESSOR</acronym>
    <official_title>A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, ADAPTIVE PHASE 2/3 STUDY OF THE EFFICACY OF LAU-7b IN THE TREATMENT OF ADULTS WITH LONG COVID AND MODERATE TO SEVERE SYMPTOMS</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>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        ESSOR is a double-blind, placebo-controlled study of the orally-administered antiviral and&#xD;
        inflammation-controlling LAU-7b for the treatment of adults with Long COVID and moderate to&#xD;
        severe symptoms.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        ESSOR is a multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study of&#xD;
        LAU-7b for the treatment of Long COVID in non-hospitalized adults with moderate to severe&#xD;
        Long COVID symptoms.&#xD;
  &#xD;
        The goal of the study is to evaluate the efficacy of LAU-7b therapy + stable symptomatic&#xD;
        standard-of-care relative to placebo + stable symptomatic standard-of-care at reducing the&#xD;
        overall Long COVID burden by improving multiple dimensions of quality-of-life and alleviating&#xD;
        the symptoms.&#xD;
  &#xD;
        This study is a logical extension of investigating LAU-7b as a potential therapeutic against&#xD;
        various phases of COVID-19.&#xD;
  &#xD;
        LAU-7b is therefore being proposed as a potential disease-modifying medication for the&#xD;
        treatment of Long COVID.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 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>Parallel Assignment</intervention_model>
      <intervention_model_description>Parallel, regimen-finding, adaptive design well-controlled randomized clinical trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Identically appearing active and placebo capsules</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline in Physical Functioning Score (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Week 12</measure>
      <time_frame>Week 0 and 12</time_frame>
      <description>The SF-36 questionnaire consists of eight sections: (1) vitality, (2) physical functioning, (3) bodily pain, (4) general health perceptions, (5) physical role functioning, (6) emotional role functioning, (7) social role functioning, and (8) mental health. All are completed at each visit and the PCS constitutes the primary outcome variable.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Safety of LAU-7b</measure>
      <time_frame>From Week 0 to Week 12</time_frame>
      <description>The safety will be assessed through the monitoring of treatment emergent adverse events, compared to placebo</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Global Impression of Change</measure>
      <time_frame>Weeks 4, 8 and 12</time_frame>
      <description>The PGI-C is a single item questionnaire that asks: &quot;Overall, how would you rate the change in your ability to perform usual daily activities since you started the study?&quot;.&#xD;
  These are the 7-point scale options: 1) &quot;very much better&quot;, 2) &quot;much better&quot;, 3) &quot;minimally better&quot;, 4) &quot;no change&quot;, 5) &quot;minimally worse&quot;, 6) &quot;much worse&quot;, or 7) &quot;very much worse&quot;.&#xD;
  Higher scores indicate a change for the worse and lower scores indicate a change for the better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in the FACIT-Fatigue scale</measure>
      <time_frame>Weeks 0, 4, 8 and 12</time_frame>
      <description>This instrument was developed to characterize fatigue, in cancer and used in other conditions with a phenotype of fatigue. It is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function. The recall period is 7 days and the response scale employs a 5-point Likert-type scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ)</measure>
      <time_frame>Weeks 0 and 12</time_frame>
      <description>This instrument was developed to characterize and evaluate the debilitation caused by a physical exertion, whether a usual daily activity or a leisure activity. It is a 10-item questionnaire that assess both the nature of post-exertional malaise and duration of symptom.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in Physical Functioning Score (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8</measure>
      <time_frame>Weeks 0, 4 and 8</time_frame>
      <description>The SF-36 questionnaire is completed in entirety at each visit and the PCS is extracted. The analysis is performed jointly with the primary outcome measure (Week 12).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in the other aspects than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36)</measure>
      <time_frame>Weeks 0, 4, 8 and 12</time_frame>
      <description>The SF-36 questionnaire consists of eight sections: (1) vitality, (2) physical functioning, (3) bodily pain, (4) general health perceptions, (5) physical role functioning, (6) emotional role functioning, (7) social role functioning, and (8) mental health. All are completed at each visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects who judge to have regained their daily usual activity level of pre-causative-infection.</measure>
      <time_frame>From Week 0 through Weeks 4, 8 and 12</time_frame>
      <description>This will be assessed by a single question with either yes or no as answer: &quot;Do you judge that you have regained the daily usual activity level you had prior to being infected by COVID-19 back in Month xxxx? By daily usual activity we mean work, leisure, physical exercise...etc.&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects achieving &gt;=25%, &gt;=50% or &gt;=75% improvement in the sum of individual Core Long COVID symptom severity as evaluated by a standard 4-level Likert scale.</measure>
      <time_frame>Weeks 4, 8 and 12</time_frame>
      <description>The Core (most common) Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.&#xD;
  Each symptom is rated as: 0=No symptom, 1=Mild symptom (no interference with daily activities), 2=Moderate symptom (interfere and may limit daily activities), and 3=Severe symptom (strong interference preventing daily activities.&#xD;
  0 and 1 are deemed not burdensome, 2 and 3 are burdensome A sum of the burdensome category is calculated for each visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in the EQ-5D-5L score</measure>
      <time_frame>Weeks 0, 4, 8 and 12</time_frame>
      <description>EQ-5D-5L is a validated Quality-of-Life short questionnaire by EuroQol Research Foundation. The EQ-5D-5L is a descriptive system in which subjects are asked to report their current state in 5 dimensions through a 5-level response scale, plus a visual analogue scale (VAS). In total there are 6 items. The higher the score is, the better the quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects with relief of at least one core Long COVID symptom for a minimum of 2 weeks.</measure>
      <time_frame>From Week 0 to Week 12</time_frame>
      <description>The core Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.&#xD;
  Relief means a reduction of severity from moderate to none, or severe to mild/none (≥2-point Likert score change from outcome #9)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to relief of the first core Long COVID symptom for a minimum of 2 weeks, among those symptoms present at baseline.</measure>
      <time_frame>From Week 0 to Week 12</time_frame>
      <description>The core Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.&#xD;
  This will be assessed through periodic inventory of the core Long COVID symptoms, performed at each visit. A longer time is worse than a short time to resolution.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects with a sustained clinical recovery, meaning a relief (as defined in outcome #11) of all core Long COVID symptoms.</measure>
      <time_frame>Weeks 4, 8 and 12</time_frame>
      <description>The core Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.&#xD;
  This will be assessed through periodic inventory of the core Long COVID symptoms, performed at each visit. A higher proportion is better than a lower proportion.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in the total number of Long COVID symptoms (core and non-core).</measure>
      <time_frame>Weeks 0, 4, 8 and 12</time_frame>
      <description>This will be assessed through periodic inventory of all the Long COVID symptoms, performed at each visit, relative to the baseline inventory. A lower total number is better than a higher total number.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects with Long COVID-related unplanned medical visits</measure>
      <time_frame>From Week 0 to Week 12</time_frame>
      <description>This will be assessed by probing the subjects at each visit. Long COVID-related unplanned medical visits includes visits to practitioner's office, urgent care visits, emergency room &lt;24h, or hospitalization &gt;24 hours.&#xD;
  A higher proportion is worse than a lower proportion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects deceased from any cause through Week 12.</measure>
      <time_frame>From Week 0 to Week 12</time_frame>
      <description>This will be assessed by probing the subjects at each visit, including caretakers or relatives if the subjects cannot be reached at a given visit.&#xD;
  A higher proportion is worse than a lower proportion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects with significant cardiovascular events</measure>
      <time_frame>From Week 0 to Week 12</time_frame>
      <description>A significant cardiovascular event is one that results in at least an acute care visit, a hospitalization or an event-related death.&#xD;
  A higher proportion is worse than a lower proportion</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Health and survival follow-up</measure>
      <time_frame>Week 24</time_frame>
      <description>Separate from the reporting and analysis of the above outcomes, a longer term contact will be made at Week 24 to assess the following: Presence or not of Long COVID symptoms, general health check-up, significant cardiovascular events and assessment of survival</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">204</enrollment>
    <condition>Long COVID</condition>
    <arm_group>
      <arm_group_label>LAU-7b for 3 cycles</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LAU-7b for 1 cycle, then placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo for 3 cycles</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LAU-7b for 3 cycles</intervention_name>
      <description>Three cycles of 14 days of once-a-day intake of LAU-7b, each followed by a treatment intake pause of14 days.</description>
      <arm_group_label>LAU-7b for 3 cycles</arm_group_label>
      <other_name>fenretinide</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LAU-7b for 1 cycle, then placebo</intervention_name>
      <description>One cycle of 14 days of once-a-day intake of LAU-7b followed by two cycles of 14 days of placebo administered similarly, each followed by a treatment intake pause of14 days.</description>
      <arm_group_label>LAU-7b for 1 cycle, then placebo</arm_group_label>
      <other_name>fenretinide</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo for 3 cycles</intervention_name>
      <description>Three cycles of 14 days of once-a-day intake of placebo, each followed by a treatment intake pause of14 days</description>
      <arm_group_label>Placebo for 3 cycles</arm_group_label>
      <other_name>sugar pill</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subjects must be 18 years and older, of either gender, and able to give informed&#xD;
               consent;&#xD;
  &#xD;
            2. Subjects diagnosed with Long COVID and exhibiting persisting, relapsing or new Long&#xD;
               COVID symptom(s) at least 12 weeks beyond the start (test positivity or symptom onset)&#xD;
               of the causative COVID-19 infection;&#xD;
  &#xD;
            3. At least one of the Long COVID symptoms must be from the core list of Long COVID&#xD;
               symptoms, and be present for a minimum of 2 weeks prior to screening and of moderate&#xD;
               or severe intensity as per the 4-level Likert severity scale (0 to 3; 0 = no symptoms;&#xD;
               1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms);&#xD;
  &#xD;
            4. 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 treatment intake and through 30 days after the last dose of the study&#xD;
               medication. Periodical abstinence is not classified as an effective method of birth&#xD;
               control. A pregnancy test for female subjects of child-bearing potential must be&#xD;
               negative at the Screening Visit;&#xD;
  &#xD;
            5. Subjects deemed capable of adequate compliance including attending scheduled follow-up&#xD;
               calls/visits for the duration of the study, have internet access and able to read and&#xD;
               answer questionnaires on electronic Patient Reported Outcomes platform (ePRO) or&#xD;
               paper;&#xD;
  &#xD;
            6. Screening laboratory test and vital signs results within ranges compatible with the&#xD;
               subject's health condition, as per investigator's judgement. See also the last&#xD;
               exclusion for certain liver function tests;&#xD;
  &#xD;
            7. Subjects deemed capable of swallowing the study treatment capsules&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subject is currently hospitalized (any reason);&#xD;
  &#xD;
            2. Pregnancy or breastfeeding;&#xD;
  &#xD;
            3. Any COVID vaccination within 4 weeks of screening or planned during study&#xD;
               participation;&#xD;
  &#xD;
            4. Presence of any health condition judged by the investigator to be directly causing one&#xD;
               or more of the most common Long COVID symptoms;&#xD;
  &#xD;
            5. Health condition deemed to possibly interfere with the study endpoints and/or the&#xD;
               safety of the subjects. For example, the following conditions should be considered&#xD;
               contraindicated for participation in the study. In case of doubt, the Investigator&#xD;
               should consult with the Sponsor's medical representative:&#xD;
  &#xD;
                 -  Febrile neutropenia;&#xD;
  &#xD;
                 -  Fibromyalgia deemed to interfere with generalized pain measurements;&#xD;
  &#xD;
                 -  Presence of end-stage cancer (palliative care).&#xD;
  &#xD;
            6. Presence or suspicion of drug or alcohol abuse, as judged by the Investigator;&#xD;
  &#xD;
            7. 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;
            8. Participation in another interventional drug, alimentary supplement, psychological or&#xD;
               device...etc. clinical trial within 30 days (or a minimum of 5 elimination half-lives&#xD;
               for drugs) prior to screening, except ongoing participation in non-interventional&#xD;
               studies;&#xD;
  &#xD;
            9. 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 (unless there are clinical evidences of hepatic&#xD;
               steatosis).&#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>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Long COVID</keyword>
    <keyword>COVID-19</keyword>
    <keyword>Antiviral</keyword>
    <keyword>Inflammation control</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Post-Acute COVID-19 Syndrome</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>
  
  
text: 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/NCT05999435
  org study id: LAU-23-01
  nct id: NCT05999435
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  ESSOR is a double-blind, placebo-controlled study of the orally-administered antiviral and
        inflammation-controlling LAU-7b for the treatment of adults with Long COVID and moderate to
        severe symptoms.
  ESSOR is a multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study of
        LAU-7b for the treatment of Long COVID in non-hospitalized adults with moderate to severe
        Long COVID symptoms.
  
        The goal of the study is to evaluate the efficacy of LAU-7b therapy + stable symptomatic
        standard-of-care relative to placebo + stable symptomatic standard-of-care at reducing the
        overall Long COVID burden by improving multiple dimensions of quality-of-life and alleviating
        the symptoms.
  
        This study is a logical extension of investigating LAU-7b as a potential therapeutic against
        various phases of COVID-19.
  
        LAU-7b is therefore being proposed as a potential disease-modifying medication for the
        treatment of Long COVID.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Parallel, regimen-finding, adaptive design well-controlled randomized clinical trial
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Identically appearing active and placebo capsules
  measure: Change from baseline in Physical Functioning Score (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Week 12
  time frame: Week 0 and 12
  description: The SF-36 questionnaire consists of eight sections: (1) vitality, (2) physical functioning, (3) bodily pain, (4) general health perceptions, (5) physical role functioning, (6) emotional role functioning, (7) social role functioning, and (8) mental health. All are completed at each visit and the PCS constitutes the primary outcome variable.
  measure: Safety of LAU-7b
  time frame: From Week 0 to Week 12
  description: The safety will be assessed through the monitoring of treatment emergent adverse events, compared to placebo
  measure: Patient Global Impression of Change
  time frame: Weeks 4, 8 and 12
  description: The PGI-C is a single item questionnaire that asks: "Overall, how would you rate the change in your ability to perform usual daily activities since you started the study?".
  These are the 7-point scale options: 1) "very much better", 2) "much better", 3) "minimally better", 4) "no change", 5) "minimally worse", 6) "much worse", or 7) "very much worse".
  Higher scores indicate a change for the worse and lower scores indicate a change for the better.
  measure: Change from baseline in the FACIT-Fatigue scale
  time frame: Weeks 0, 4, 8 and 12
  description: This instrument was developed to characterize fatigue, in cancer and used in other conditions with a phenotype of fatigue. It is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function. The recall period is 7 days and the response scale employs a 5-point Likert-type scale.
  measure: Change from baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ)
  time frame: Weeks 0 and 12
  description: This instrument was developed to characterize and evaluate the debilitation caused by a physical exertion, whether a usual daily activity or a leisure activity. It is a 10-item questionnaire that assess both the nature of post-exertional malaise and duration of symptom.
  measure: Change from baseline in Physical Functioning Score (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8
  time frame: Weeks 0, 4 and 8
  description: The SF-36 questionnaire is completed in entirety at each visit and the PCS is extracted. The analysis is performed jointly with the primary outcome measure (Week 12).
  measure: Change from baseline in the other aspects than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36)
  time frame: Weeks 0, 4, 8 and 12
  description: The SF-36 questionnaire consists of eight sections: (1) vitality, (2) physical functioning, (3) bodily pain, (4) general health perceptions, (5) physical role functioning, (6) emotional role functioning, (7) social role functioning, and (8) mental health. All are completed at each visit.
  measure: Proportion of subjects who judge to have regained their daily usual activity level of pre-causative-infection.
  time frame: From Week 0 through Weeks 4, 8 and 12
  description: This will be assessed by a single question with either yes or no as answer: "Do you judge that you have regained the daily usual activity level you had prior to being infected by COVID-19 back in Month xxxx? By daily usual activity we mean work, leisure, physical exercise...etc."
  measure: Proportion of subjects achieving >=25%, >=50% or >=75% improvement in the sum of individual Core Long COVID symptom severity as evaluated by a standard 4-level Likert scale.
  time frame: Weeks 4, 8 and 12
  description: The Core (most common) Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.
  Each symptom is rated as: 0=No symptom, 1=Mild symptom (no interference with daily activities), 2=Moderate symptom (interfere and may limit daily activities), and 3=Severe symptom (strong interference preventing daily activities.
  0 and 1 are deemed not burdensome, 2 and 3 are burdensome A sum of the burdensome category is calculated for each visit.
  measure: Change from baseline in the EQ-5D-5L score
  time frame: Weeks 0, 4, 8 and 12
  description: EQ-5D-5L is a validated Quality-of-Life short questionnaire by EuroQol Research Foundation. The EQ-5D-5L is a descriptive system in which subjects are asked to report their current state in 5 dimensions through a 5-level response scale, plus a visual analogue scale (VAS). In total there are 6 items. The higher the score is, the better the quality of life.
  measure: Proportion of subjects with relief of at least one core Long COVID symptom for a minimum of 2 weeks.
  time frame: From Week 0 to Week 12
  description: The core Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.
  Relief means a reduction of severity from moderate to none, or severe to mild/none (≥2-point Likert score change from outcome #9)
  measure: Time to relief of the first core Long COVID symptom for a minimum of 2 weeks, among those symptoms present at baseline.
  time frame: From Week 0 to Week 12
  description: The core Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.
  This will be assessed through periodic inventory of the core Long COVID symptoms, performed at each visit. A longer time is worse than a short time to resolution.
  measure: Proportion of subjects with a sustained clinical recovery, meaning a relief (as defined in outcome #11) of all core Long COVID symptoms.
  time frame: Weeks 4, 8 and 12
  description: The core Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.
  This will be assessed through periodic inventory of the core Long COVID symptoms, performed at each visit. A higher proportion is better than a lower proportion.
  measure: Change from baseline in the total number of Long COVID symptoms (core and non-core).
  time frame: Weeks 0, 4, 8 and 12
  description: This will be assessed through periodic inventory of all the Long COVID symptoms, performed at each visit, relative to the baseline inventory. A lower total number is better than a higher total number.
  measure: Proportion of subjects with Long COVID-related unplanned medical visits
  time frame: From Week 0 to Week 12
  description: This will be assessed by probing the subjects at each visit. Long COVID-related unplanned medical visits includes visits to practitioner's office, urgent care visits, emergency room <24h, or hospitalization >24 hours.
  A higher proportion is worse than a lower proportion
  measure: Proportion of subjects deceased from any cause through Week 12.
  time frame: From Week 0 to Week 12
  description: This will be assessed by probing the subjects at each visit, including caretakers or relatives if the subjects cannot be reached at a given visit.
  A higher proportion is worse than a lower proportion
  measure: Proportion of subjects with significant cardiovascular events
  time frame: From Week 0 to Week 12
  description: A significant cardiovascular event is one that results in at least an acute care visit, a hospitalization or an event-related death.
  A higher proportion is worse than a lower proportion
  measure: Health and survival follow-up
  time frame: Week 24
  description: Separate from the reporting and analysis of the above outcomes, a longer term contact will be made at Week 24 to assess the following: Presence or not of Long COVID symptoms, general health check-up, significant cardiovascular events and assessment of survival
  arm group label: LAU-7b for 3 cycles
  arm group type: Experimental
  description: Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.
  arm group label: LAU-7b for 1 cycle, then placebo
  arm group type: Experimental
  description: Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.
  arm group label: Placebo for 3 cycles
  arm group type: Placebo Comparator
  description: Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.
  intervention type: Drug
  intervention name: LAU-7b for 3 cycles
  description: Three cycles of 14 days of once-a-day intake of LAU-7b, each followed by a treatment intake pause of14 days.
  arm group label: LAU-7b for 3 cycles
  other name: fenretinide
  intervention type: Drug
  intervention name: LAU-7b for 1 cycle, then placebo
  description: One cycle of 14 days of once-a-day intake of LAU-7b followed by two cycles of 14 days of placebo administered similarly, each followed by a treatment intake pause of14 days.
  arm group label: LAU-7b for 1 cycle, then placebo
  other name: fenretinide
  intervention type: Other
  intervention name: Placebo for 3 cycles
  description: Three cycles of 14 days of once-a-day intake of placebo, each followed by a treatment intake pause of14 days
  arm group label: Placebo for 3 cycles
  other name: sugar pill
  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
  responsible party type: Sponsor
  mesh term: Post-Acute COVID-19 Syndrome
  mesh term: Fenretinide