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

NCT05999435 | Completed Phase 2 Results DMC

• 1 other identifier: LAU-23-01
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Long COVID

Keywords

Long COVID; COVID-19; Antiviral; Inflammation control

Outcome Measures

Primary Outcomes (1)

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

  The SF-36 questionnaire consists of 36 items grouped in eight health domains, vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health, that can be aggregated to two summary scales, physical component summary (PCS ) and mental component summary (MCS). The PCS summarizes the physical status and constitutes the primary outcome variable. Each health domain score consists of the sum scores of the assigned questions. Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, ie, severe disability) to 100 (no health restrictions). A higher score means a better physical status. The calculation process for the PCS has been previously described by Taft et al. 2001.

  Week 0 and 12

Secondary Outcomes (19)

• Safety of LAU-7b, Overview

  From Week 0 to Week 12

• Patient Global Impression of Change (PGI-C)

  Weeks 4, 8 and 12

• Proportion of Participants With Marked Improvement in PGI-C

  Weeks 4, 8 and 12

• Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale

  Weeks 0, 4, 8 and 12

• Change From Baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ)

  Weeks 0 and 12

Other Outcomes (13)

• Health and Survival Follow-up (Week 24), Long COVID Symptom Count

  Week 24

• Health and Survival Follow-up (Week 24), Significant Cardiovascular Events

  Week 24

• Baseline Values of Systemic Biomarkers of Hematologic Function (Except Hemoglobin & Hematocrit)

  Week 0

Study Arms (3)

LAU-7b for 3 cycles

EXPERIMENTAL

Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.

Drug: LAU-7b for 3 cycles

LAU-7b for 1 cycle, then placebo

EXPERIMENTAL

Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.

Drug: LAU-7b for 1 cycle, then placebo

Placebo for 3 cycles

PLACEBO COMPARATOR

Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.

Other: Placebo for 3 cycles

Interventions

LAU-7b for 1 cycle, then placebo DRUG

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 of 14 days.

Also known as: fenretinide

LAU-7b for 1 cycle, then placebo

Placebo for 3 cycles OTHER

Three cycles of 14 days of once-a-day intake of placebo, each followed by a treatment intake pause of 14 days

Also known as: sugar pill

Placebo for 3 cycles

LAU-7b for 3 cycles DRUG

Three cycles of 14 days of once-a-day intake of LAU-7b, each followed by a treatment intake pause of 14 days.

Also known as: fenretinide

LAU-7b for 3 cycles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Subjects deemed capable of swallowing the study treatment capsules

You may not qualify if:

• 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:
• Febrile neutropenia;
• Fibromyalgia deemed to interfere with generalized pain measurements;
• Presence of end-stage cancer (palliative care).
• 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;
• 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;
• 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).

Sponsors & Collaborators

• Laurent Pharmaceuticals Inc.: lead

Study Sites (5)

CIUSS du Saguenay-Lac-St-Jean - Hôpital Chicoutimi

Chicoutimi, Quebec, G7H 5H6, Canada

Location

Institut de Recherches Cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Diex Recherche Québec Inc.

Québec, Quebec, G1V 4T3, Canada

Location

Centre Hospitalier de l'Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Interventions

Fenretinide; Sugars

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Carbohydrates

Results Point of Contact

• Title: Vice President Clinical Development
• Organization: Laurent Pharmaceuticals Inc.

jmhoule@laurentpharma.com

514-941-2313

Study Officials

• Jean-Marie Houle, PhD

  Laurent Pharmaceuticals Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Identically appearing active and placebo capsules
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel, regimen-finding, adaptive design well-controlled randomized clinical trial

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 21, 2023
• Study Start: November 15, 2023
• Primary Completion: August 5, 2024
• Study Completion: November 30, 2024
• Last Updated: January 6, 2026
• Results First Posted: January 6, 2026

Record last verified: 2025-12

Locations

CA (5)