ESSOR is a double-blind, placebo-controlled study of the orally-administered antiviraland inflammation-controlling LAU-7b for the treatment of adults with Long COVID andmoderate 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.
Drug: LAU-7b for 3 cycles
Three cycles of 14 days of once-a-day intake of LAU-7b, each followed by a treatment
intake pause of14 days.
Other Name: fenretinide
Drug: LAU-7b for 1 cycle, then placebo
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.
Other Name: fenretinide
Other: Placebo for 3 cycles
Three cycles of 14 days of once-a-day intake of placebo, each followed by a treatment
intake pause of14 days
Other Name: sugar pill
Inclusion Criteria:
1. Subjects must be 18 years and older, of either gender, and able to give informed
consent;
2. Subjects diagnosed with Long COVID and exhibiting persisting, relapsing or new Long
COVID symptom(s) at least 12 weeks beyond the start (test positivity or symptom
onset) of the causative COVID-19 infection;
3. At least one of the Long COVID symptoms must be from the core list of Long COVID
symptoms, and be present for a minimum of 2 weeks prior to screening and of moderate
or severe intensity as per the 4-level Likert severity scale (0 to 3; 0 = no
symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms);
4. 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 treatment intake 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 for female subjects of
child-bearing potential must be negative at the Screening Visit;
5. Subjects deemed capable of adequate compliance including attending scheduled
follow-up calls/visits for the duration of the study, have internet access and able
to read and answer questionnaires on electronic Patient Reported Outcomes platform
(ePRO) or paper;
6. Screening laboratory test and vital signs results within ranges compatible with the
subject's health condition, as per investigator's judgement. See also the last
exclusion for certain liver function tests;
7. Subjects deemed capable of swallowing the study treatment capsules
Exclusion Criteria:
1. Subject is currently hospitalized (any reason);
2. Pregnancy or breastfeeding;
3. Any COVID vaccination within 4 weeks of screening or planned during study
participation;
4. Presence of any health condition judged by the investigator to be directly causing
one or more of the most common Long COVID symptoms;
5. Health condition deemed to possibly interfere with the study endpoints and/or the
safety of the subjects. For example, the following conditions should be considered
contraindicated for participation in the study. In case of doubt, the Investigator
should consult with the Sponsor's medical representative:
- Febrile neutropenia;
- Fibromyalgia deemed to interfere with generalized pain measurements;
- Presence of end-stage cancer (palliative care).
6. Presence or suspicion of drug or alcohol abuse, as judged by the Investigator;
7. 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;
8. Participation in another interventional drug, alimentary supplement, psychological
or device...etc. clinical trial within 30 days (or a minimum of 5 elimination
half-lives for drugs) prior to screening, except ongoing participation in
non-interventional studies;
9. Presence of total bilirubin >1.5 x Upper Limit of Normal (in the absence of
demonstrated Gilbert's syndrome), alanine aminotransferase and/or aspartate
aminotransferase > 2.5 x Upper Limit of Normal (unless there are clinical evidences
of hepatic steatosis).
CIUSS du Saguenay-Lac-St-Jean - Hôpital Chicoutimi
Chicoutimi, Quebec, Canada
Institut de Recherches Cliniques de Montréal
Montréal, Quebec, Canada
Montreal General Hospital
Montréal, Quebec, Canada
Centre Hospitalier de l'Université de Sherbrooke
Sherbrooke, Quebec, Canada
Diex Recherche Québec Inc.
Québec, Canada
Jean-Marie Houle, PhD, Study Director
Laurent Pharmaceuticals Inc.