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.
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
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.
Inclusion Criteria:
1. Subjects must exhibit symptoms (including at least one lower respiratory symptom such
as shortness of breath or dyspnea) of COVID-19 disease at screening and/or since the
start of their hospitalization (may include treated symptoms;
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 or a former smoker with a 20 pack-years of smoking history;
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, D-dimer >3.0 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;
5. Subjects must be under observation by, or admitted to a controlled facility or
hospital to receive standard-of-care for COVID-19 disease (care for COVID-19 disease
should be for no more than 72 hours before screening, including any prior stay in
another hospital);
6. Subject's health status must be 3 or 4 on the ordinal scale, and not previously a "5
or 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 (Child-Pugh B or C);
3. Presence or history of stage 4 severe chronic kidney disease or dialysis
requirement;
4. Febrile neutropenia;
5. Presence of end-stage cancer.
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)
<50 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;
7. Patient expected to be transferred to ICU or die in the next 24 hours.
Chandler Regional Medical Center / Mercy Gilbert Medical Center
Chandler, Arizona, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Nuvance Health - Danbury Hospital
Danbury, Connecticut, United States
MedStar Washington Hospital Center
Washington, District of Columbia, United States
Baptist Medical Center Beaches
Jacksonville Beach, Florida, United States
St Lukes Hospital
Boise, Idaho, United States
NorthShore University Health System - Swedish Hospital
Chicago, Illinois, United States
NorthShore University Health System - Glenbrook Hospital
Glenview, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Anne Arundel Medical Center, 2001 Medical Parkway, Belcher Pavillion
Annapolis, Maryland, United States
Wayne State University, Harper University Hospital and Detroit Receiving Hospital
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Staten Island University Hospital North
Staten Island, New York, United States
Wake Forest University Health Science
Winston-Salem, North Carolina, United States
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States
Kettering Health
Kettering, Ohio, United States
Robert Packer Hospital
Sayre, Pennsylvania, United States
University of Texas Southwestern
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
PRX Research /Dallas Regional Medical Center
Mesquite, Texas, United States
University of Utah Health
Salt Lake City, Utah, United States
Centre d'études cliniques CIUSS SLJ, Hôpital Chicoutimi
Chicoutimi, Quebec, Canada
CIUSSSS de l'Est-de-l'Ile-de-Montréal, Hôpital Maisonneuve-Rosemont
Montréal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal
Montréal, Quebec, Canada
Jewish General Hospital
Montréal, Quebec, Canada
McGill University Health Centre
Montréal, Quebec, Canada
CISSS Des Laurentides
Saint-Jérôme, Quebec, Canada
Jean-Marie Houle, PhD
514-941-2313
jmhoule@laurentpharma.com
Radu Pislariu, MD
514-513-2252
rpislariu@laurentpharma.com
Jean-Marie Houle, PhD, Study Director
Laurent Pharmaceuticals Inc.