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Study of LAU-7b for the Treatment of COVID-19 Disease in Adults (RESOLUTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04417257
Recruitment Status : Active, not recruiting
First Posted : June 4, 2020
Last Update Posted : July 1, 2021
Sponsor:
Information provided by (Responsible Party):
Laurent Pharmaceuticals Inc.

Brief Summary:
A randomized, double-blind, placebo-controlled Phase 2 Study of LAU-7b against confirmed COVID-19 Disease in hospitalized patients at a higher risk of complications.

Condition or disease Intervention/treatment Phase
COVID-19 Disease Drug: LAU-7b Drug: Placebo oral capsule Phase 2

Detailed Description:

RESOLUTION is a multicenter, randomized, double-blind, placebo-controlled Phase 2 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, randomized, parallel groups and placebo-controlled trial
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)
Primary Purpose: Treatment
Official Title: RESOLUTION: A Double-blind, Randomized, Placebo-controlled, Pilot Phase II Study of the Efficacy and Safety of LAU-7b in the Treatment of Adult Hospitalized Patients With COVID-19 Disease
Actual Study Start Date : June 29, 2020
Estimated Primary Completion Date : July 15, 2021
Estimated Study Completion Date : August 15, 2021

Arm Intervention/treatment
Experimental: LAU-7b
Active drug as LAU-7b capsules
Drug: LAU-7b
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.
Other Name: fenretinide

Placebo Comparator: Placebo
Placebo oral capsule (as inactive capsules identical to active arm)
Drug: Placebo oral capsule
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.




Primary Outcome Measures :
  1. Proportion of patients alive and free of respiratory failure (Ordinal Scale scores 1-4) [ Time Frame: On Day 29 ]

    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.

    1. Not hospitalized, no limitations on activities;
    2. Not hospitalized, limitation on activities;
    3. Hospitalized, not requiring supplemental oxygen;
    4. Hospitalized, requiring supplemental oxygen;
    5. Hospitalized, on non-invasive ventilation or high flow oxygen devices;
    6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation;
    7. Death.


Secondary Outcome Measures :
  1. 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 ]
    This will be assessed through monitoring and probing

  2. Health status of the patient on the 7-point Ordinal Scale compared to placebo [ Time Frame: On Days 14 and 29 ]
    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.

  3. 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 ]
    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.

  4. 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 ]
    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.

  5. 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 ]
    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.

  6. Rate of COVID-19 disease-related transfer to mechanical ventilation, depicted by a change from baseline in the ordinal scale score to category 6, compared to placebo [ Time Frame: From baseline to Day 60 ]
    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.

  7. 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 ]
    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.

  8. Time to an improvement of one category on the ordinal scale patient health status, compared to placebo [ Time Frame: From baseline to Day 60 ]
    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.

  9. 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 ]
    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.

  10. 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 ]
    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.

  11. 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 ]
    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.

  12. Duration of hospitalization (days) within the study period Days 1-29, compared to placebo [ Time Frame: From baseline to Day 60 ]
    Monitoring of the hospitalization

  13. Time to attain an undetectable viral load through oropharyngeal swabs done at specified times, compared to placebo [ Time Frame: On Days 1, 5, 8, 12 and 14 ]
    This will be assessed through serial oropharyngeal swabs for SARS-CoV-2 viral detection

  14. 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 ]
    This will be assessed through questionnaire filling, in person or remotely



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must exhibit symptoms of COVID-19 disease at screening;
  2. Subjects must be 18 years and older, of either gender;
  3. Subjects must have at least one of the following factors/co-morbidities:

    1. Controlled or uncontrolled diabetes;
    2. Pre-existing cardiovascular disease, including hypertension;
    3. Pre-existing respiratory disease such as COPD, asthma, emphysema;
    4. Active smoker with a 20 pack-years of smoking;
    5. Obesity as depicted by body mass index ≥ 30;
    6. Laboratory tests indicative of a higher risk of COVID-19-related complications, such as troponin >1.5 upper limit of normal and/or CRP >1.5 upper limit of normal
    7. Patient aged 70 years and older who, based on the judgment of the Investigator, is at a higher risk of developing complications.
  4. Subjects must have a documented positive test for the SARS-CoV-2 virus or be suspected to be positive and with a test result pending;
  5. Subjects must be under observation by, or admitted to a controlled facility or hospital to receive standard-of-care for COVID-19 disease;
  6. Subject's health status must be 3, 4 or 5 on the ordinal scale, and not previously a 6;
  7. If female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception, must be: practicing a highly effective method of birth control (acceptable methods include intrauterine device, complete abstinence, spermicide + barrier, male partner surgical sterilization, or hormonal contraception) during the study and through 30 days after the last dose of the study medication. Periodical abstinence is not classified as an effective method of birth control. A pregnancy test must be negative at the Screening Visit;
  8. Subjects must have the ability to understand and give informed consent, which can be verbal with a witness, according to local requirements;
  9. Subjects deemed capable of adequate compliance including attending scheduled visits for the duration of the study;
  10. Subjects must be able to swallow the study drug capsules.

Exclusion Criteria:

  1. Pregnancy or breastfeeding;
  2. Health condition deemed to possibly interfere with the study endpoints and/or the safety of the patients. For example, the following conditions should be considered contraindicated for participation in the study, but this is not an exhaustive list. In case of doubt, the Investigator should consult with the sponsor's medical representative:

    1. Presence of inherited retinitis pigmentosa;
    2. Presence or history of liver failure;
    3. Presence or history of stage 4 severe chronic kidney disease or dialysis requirement;
    4. Febrile neutropenia;
    5. Presence of active cancer treated with systemic chemotherapy or radiotherapy.
  3. Known history of a severe allergy or sensitivity to retinoids, or with known allergies to excipients in the oral capsule formulation proposed to be used in the study;
  4. Participation in another drug clinical trial within 30 days (or a minimum of 5 elimination half-lives) prior to screening, except ongoing participation in non-interventional studies;
  5. Calculated creatinine clearance (CrCL, using the Cockroft-Gault equation for example) <60 ml/min.
  6. Presence of total bilirubin >1.5 x ULN (in the absence of demonstrated Gilbert's syndrome), ALT and/or AST > 2.5 x ULN.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417257


Locations
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United States, Arizona
Chandler Regional Medical Center / Mercy Gilbert Medical Center
Chandler, Arizona, United States, 85224
United States, Florida
Baptist Medical Center Beaches
Jacksonville Beach, Florida, United States, 32250
United States, Idaho
St Lukes Hospital
Boise, Idaho, United States, 83702
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Maryland
Anne Arundel Medical Center, 2001 Medical Parkway, Belcher Pavillion
Annapolis, Maryland, United States, 21401
United States, Michigan
Wayne State University, Harper University Hospital and Detroit Receiving Hospital
Detroit, Michigan, United States, 48201
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Texas
Houston Methodist Hospital
Houston, Texas, United States, 77030
Canada, Quebec
Centre d'études cliniques CIUSS SLJ, Hôpital Chicoutimi
Chicoutimi, Quebec, Canada, G7H 5H6
CIUSSSS de l'Est-de-l'Ile-de-Montréal, Hôpital Maisonneuve-Rosemont
Montréal, Quebec, Canada, H1T 2M4
Centre Hospitalier de l'Université de Montréal
Montréal, Quebec, Canada, H2X2P1
Jewish General Hospital
Montréal, Quebec, Canada, H3T 1E2
McGill University Health Centre
Montréal, Quebec, Canada, H4A 3J1
CISSS Des Laurentides
Saint-Jérôme, Quebec, Canada, J7Z 5T3
Sponsors and Collaborators
Laurent Pharmaceuticals Inc.
Investigators
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Principal Investigator: Ramy Saleh, MD McGill University Health Centre/Research Institute of the McGill University Health Centre
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Responsible Party: Laurent Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT04417257    
Other Study ID Numbers: LAU-20-01
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: July 1, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Laurent Pharmaceuticals Inc.:
Inflammation
Antiviral
Host-directed treatment
Docosahexaenoic acid
Pro-resolving
Additional relevant MeSH terms:
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Fenretinide
Antineoplastic Agents
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs