Infections and infectious diseases / Virology / Vaccines
Affection post-COVID
Source : Import from center
Cancer stages
Not applicable
Participants profils
Participants gender(s)
ALL
Source : Import from center
Subjects aptitude
Selection criterias
Inclusion 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).
Source : Import from center
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 disorder 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 ULN (in the absence of demonstrated Gilbert’s syndrome), ALT and/or AST > 2.5 x ULN.
Source : Import from center
Cohorts
Proposed Therapy or Intervention
Cohorts
Name
Medical condition
Treatment
Recruitment status
LAU-7b for 3 cycles
Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.
Data not available
Unknown
LAU-7b for 1 cycle, then placebo
Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.
Data not available
Unknown
Placebo for 3 cycles
Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.
Data not available
Unknown
LAU-7b for 3 cycles
Recruitment status
unknown
Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.
LAU-7b for 1 cycle, then placebo
Recruitment status
unknown
Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.
Placebo for 3 cycles
Recruitment status
unknown
Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.
Current data since :
August 02, 2025 20:00
Study's description
Study description
Study 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.
Source : Import from center
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.
Source : Import from center
Locations
Locations
Participating centers
6
centers
CENTRE HOSPITALIER UNIVERSITAIRE DE SHERBROOKE
***
Sherbrooke
QUÉBEC, CANADA
Local recruitment
Recruiting status:
CLOSED
click here for more information about this center
Cohorts
Centre hospitalier universitaire de Sherbrooke
Data not available
Current data since :
May 10, 2025 00:20
CENTRE INTÉGRÉ UNIVERSITAIRE DE SANTÉ ET DE SERVICES SOCIAUX DU SAGUENAY–LAC-SAINT-JEAN
***
Chicoutimi
QUÉBEC, CANADA
Local recruitment
Recruiting status:
CLOSED
click here for more information about this center
Cohorts
Centre intégré universitaire de santé et de services sociaux du Saguenay–Lac-Saint-Jean
Data not available
Current data since :
April 10, 2025 00:20
CENTRE UNIVERSITAIRE DE SANTÉ MCGILL
*
Montréal
QUÉBEC, CANADA
Local recruitment
Recruiting status:
CLOSED
click here for more information about this center
Cohorts
Centre universitaire de santé McGill
Data not available
Current data since :
April 15, 2025 00:20
CENTRE HOSPITALIER DE L'UNIVERSITÉ DE SHERBROOKE
Sherbrooke
QUEBEC, CANADA
Local recruitment
Recruiting status:
CLOSED
DIEX RECHERCHE QUÉBEC
Québec
QUEBEC, CANADA
Local recruitment
Recruiting status:
CLOSED
MONTREAL GENERAL HOSPITAL
Montréal
PQ, CANADA
Local recruitment
Recruiting status:
CLOSED
Information source
Last modification :
August 02, 2025
Current data since :
15 Aug 06:31
Data source :
clinicaltrials.gov, Nagano
