CompletedPhase 2/3

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

Canada272 participantsStarted 2023-11-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subjects must be 18 years and older, of either gender, and able to give informed consent;
✓. 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;
✓. 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);
✓. 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;
✓. 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;

Exclusion criteria

✕. Subjects deemed capable of swallowing the study treatment capsules
✕. Subject is currently hospitalized (any reason);
✕. Pregnancy or breastfeeding;
✕. Any COVID vaccination within 4 weeks of screening or planned during study participation;
✕. Presence of any health condition judged by the investigator to be directly causing one or more of the most common Long COVID symptoms;
✕. 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:
✕. Presence or suspicion of drug or alcohol abuse, as judged by the Investigator;
✕. 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;

What they're measuring

Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Week 12

Timeframe: Week 0 and 12

Trial details

NCT IDNCT05999435

SponsorLaurent Pharmaceuticals Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-05

Results submitted2025-09-09

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