Overview

Study of LAU-7b for the Treatment of Long COVID in Adults

Status:
Active, not recruiting
Trial end date:
2024-08-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Laurent Pharmaceuticals Inc.
Treatments:
Fenretinide
Criteria
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).