Long COVIDPhase 2/3ESSORNCT05999435
Study of LAU-7b for the Treatment of Long COVID in Adults
A Phase 2/3 study testing LAU-7b for 3 cycles in people with Long COVID, run by Laurent Pharmaceuticals Inc. at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID
- What is being tested?
- LAU-7b for 3 cycles
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 272 participants
- Where
- 5 sitesCanada
- Study dates
- 15 Nov 2023to 30 Nov 2024
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 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;
- Subjects deemed capable of swallowing the study treatment capsules
Who cannot join
- 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;
Show all 12Show fewer
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
CIUSS du Saguenay-Lac-St-Jean - Hôpital Chicoutimi
Chicoutimi, Quebec, G7H 5H6
Institut de Recherches Cliniques de Montréal
Montreal, Quebec, H2W 1R7
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Diex Recherche Québec Inc.
Québec, Quebec, G1V 4T3
Centre Hospitalier de l'Université de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, ADAPTIVE PHASE 2/3 STUDY OF THE EFFICACY OF LAU-7b IN THE TREATMENT OF ADULTS WITH LONG COVID AND MODERATE TO SEVERE SYMPTOMS
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.
Read the detailed description
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.
- Conditions
- Long COVID
- Being tested
- LAU-7b for 3 cycles, LAU-7b for 1 cycle, then placebo, Placebo for 3 cycles
- Keywords
- Long COVID, COVID-19, Antiviral, Inflammation control
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAU-7b for 3 cyclesDrug
Also called fenretinide
Three cycles of 14 days of once-a-day intake of LAU-7b, each followed by a treatment intake pause of 14 days.
LAU-7b for 1 cycle, then placeboDrug
Also called fenretinide
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.
Placebo for 3 cyclesOther
Also called sugar pill
Three cycles of 14 days of once-a-day intake of placebo, each followed by a treatment intake pause of 14 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Placebo for 3 cycles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0 and 12
Secondary outcomes (19)
Safety of LAU-7b, Overview
Number of participants with adverse events. The safety was assessed through the monitoring of adverse events including laboratory test abnormalities, serious adverse events and adverse events leading to study treatment discontinuation. Treatment-emergent adverse event is defined as any adverse event with onset date on or after the first dose of study drug and on or before the Week 12 in person follow-up or until early termination or death, whichever occurred first.
Measured: From Week 0 to Week 12
Patient Global Impression of Change (PGI-C)
The PGI-C is a single item questionnaire that asks: "Overall, how would you rate the change in your ability to perform usual daily activities since you started the study?".
These are the 7-point scale options: 1) "very much better", 2) "much better", 3) "minimally better", 4) "no change", 5) "minimally worse", 6) "much worse", or 7) "very much worse".
Higher scores indicate a change for the worse and lower scores indicate a change for the better.
Measured: Weeks 4, 8 and 12
Proportion of Participants With Marked Improvement in PGI-C
Marked improvement includes "Very much improved" and Much improved". The PGI-C is a single item questionnaire that asks: "Overall, how would you rate the change in your ability to perform usual daily activities since you started the study?".
These are the 7-point scale options: 1) "very much better", 2) "much better", 3) "minimally better", 4) "no change", 5) "minimally worse", 6) "much worse", or 7) "very much worse".
Higher scores indicate a change for the worse and lower scores indicate a change for the better.
Measured: Weeks 4, 8 and 12
Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale
This instrument was developed to characterize fatigue, in cancer and used in other conditions with a phenotype of fatigue. It is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function. The recall period is 7 days and the response scale employs a 5-point Likert-type scale. The final total score is the sum of the responses for all 13 items and can range from 0 to 52. A higher score means less fatigue.
Measured: Weeks 0, 4, 8 and 12
Change From Baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ)
This instrument was developed to characterize and evaluate the debilitation caused by a physical exertion, whether a usual daily activity or a leisure activity. It is a 10-item questionnaire that assess both the nature of post-exertional malaise (PEM) and duration of symptom. In this study, the presence or not of PEM (based on frequency and severity of 5 PEM items) is determined by the questionnaire. The endpoint of the study is the proportion of participants with PEM at baseline and Week 12, compared between treatment groups.
Measured: Weeks 0 and 12
Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8
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. The analysis is performed jointly with the primary outcome measure (Week 12). A positive change from baseline value means improvement, negative value means worsening.
Measured: Weeks 0, 4 and 8
Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36)
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). 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 outcome. The study endpoint is the change from baseline in score, a positive change from baseline value means improvement and a negative value means worsening outcome. For sake of conciseness, only Week 12 comparisons are presented.
Measured: Weeks 0, 4, 8 and 12
Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection.
This will be assessed by a single question with either yes or no as answer: "Do you judge that you have regained the daily usual activity level you had prior to being infected by COVID-19 back in Month xxxx? By daily usual activity we mean work, leisure, physical exercise...etc."
Measured: From Week 0 through Weeks 4, 8 and 12
Proportion of Subjects Achieving >=25% (>=50% and >=75% Presented Separately) Improvement in the Sum of Individual Core Long COVID Symptom Severity as Evaluated by a Standard 4-level Likert Scale.
The Core (most common) Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.
Each symptom is rated as: 0=No symptom, 1=Mild symptom (no interference with daily activities), 2=Moderate symptom (interfere and may limit daily activities), and 3=Severe symptom (strong interference preventing daily activities. The higher the rating is, worse is the symptom.
0 and 1 are deemed not burdensome, 2 and 3 are burdensome. A sum of the burdensome category is calculated for each visit and is the endpoint being evaluated for improvement since burdensome symptoms are those with highest impact on daily usual activity level.
Measured: Weeks 4, 8 and 12
Proportion of Subjects Achieving >=50% (>=25% and >=75% Presented Separately) Improvement in the Sum of Individual Core Long COVID Symptom Severity as Evaluated by a Standard 4-level Likert Scale.
The Core (most common) Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.
Each symptom is rated as: 0=No symptom, 1=Mild symptom (no interference with daily activities), 2=Moderate symptom (interfere and may limit daily activities), and 3=Severe symptom (strong interference preventing daily activities. The higher the rating is, worse is the symptom.
0 and 1 are deemed not burdensome, 2 and 3 are burdensome. A sum of the burdensome category is calculated for each visit and is the endpoint being evaluated for improvement since burdensome symptoms are those with highest impact on daily usual activity level.
Measured: Weeks 4, 8 and 12
Proportion of Subjects Achieving >=75% (>=25% and >=50% Presented Separately) Improvement in the Sum of Individual Core Long COVID Symptom Severity as Evaluated by a Standard 4-level Likert Scale.
The Core (most common) Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.
Each symptom is rated as: 0=No symptom, 1=Mild symptom (no interference with daily activities), 2=Moderate symptom (interfere and may limit daily activities), and 3=Severe symptom (strong interference preventing daily activities. The higher the rating is, worse is the symptom.
0 and 1 are deemed not burdensome, 2 and 3 are burdensome. A sum of the burdensome category is calculated for each visit and is the endpoint being evaluated for improvement since burdensome symptoms are those with highest impact on daily usual activity level.
Measured: Weeks 4, 8 and 12
Change From Baseline in the EuroQol-5 Dimensions -5 Levels (EQ-5D-5L) Score
EQ-5D-5L is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). Higher values indicate worse outcomes, while lower indicate better outcomes. The subscales are combined to compute a total score index, adjusted for a standard value of general population in a country/region and averaged to produce the mean and SD. The Summary index value range is from 0 to 1, where 1 is considered the best possible health and 0 is the worst possible health. For the change in score, a positive number indicates that the scores improved from baseline.
Measured: Weeks 0, 4, 8 and 12
Proportion of Subjects With Relief of at Least One Core Burdensome Long COVID Symptom for a Minimum of 2 Weeks.
The core Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.
Each symptom is rated as: 0=No symptom, 1=Mild symptom (no interference with daily activities), 2=Moderate symptom (interfere and may limit daily activities), and 3=Severe symptom (strong interference preventing daily activities. The higher the rating is, worse is the symptom.
0 and 1 are deemed not burdensome, 2 and 3 are burdensome.
Relief means a reduction of severity from moderate to none, or severe to mild/none (≥2-point Likert score change)
Measured: From Week 0 to Week 12
Time to Relief of the First Core Burdensome Long COVID Symptom for a Minimum of 2 Weeks, Among Those Symptoms Present at Baseline.
The core Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (brain fog or memory fog) and mental health symptoms. Each symptom is rated as: 0=No symptom, 1=Mild symptom (no interference with daily activities), 2=Moderate symptom (interfere and may limit daily activities), and 3=Severe symptom (strong interference preventing daily activities. The higher the rating is, worse is the symptom. 0 and 1 are deemed not burdensome, 2 and 3 are burdensome. This will be assessed through periodic inventory of the core Long COVID symptoms, performed at each visit. Relief means a reduction of severity from moderate to none, or severe to mild/none (≥2-point Likert score change). A longer time is worse than a short time to resolution.
Measured: From Week 0 to Week 12
Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms.
The core Long COVID symptoms are: fatigue, trouble sleeping, shortness of breath, general pain and discomfort, cognitive problems (most commonly known as brain fog or memory fog) and mental health symptoms.
Each symptom is rated as: 0=No symptom, 1=Mild symptom (no interference with daily activities), 2=Moderate symptom (interfere and may limit daily activities), and 3=Severe symptom (strong interference preventing daily activities. The higher the rating is, worse is the symptom.
0 and 1 are deemed not burdensome, 2 and 3 are burdensome.
This will be assessed through periodic inventory of the core Long COVID symptoms, performed at each visit. Relief means a reduction of severity from moderate to none, or severe to mild/none (≥2-point Likert score change). A higher proportion is better than a lower proportion.
Measured: Weeks 4, 8 and 12
Change From Baseline in the Total Number of Long COVID Symptoms (Core and Non-core).
This will be assessed through periodic inventory of all the Long COVID symptoms, performed at each visit, relative to the baseline inventory. A lower total number is better than a higher total number.
Measured: Weeks 0, 4, 8 and 12, as well as the longer term visit at Week 24
Proportion of Subjects With Long COVID-related Unplanned Medical Visits
This will be assessed by probing the subjects at each visit. Long COVID-related unplanned medical visits includes visits to practitioner's office, urgent care visits, emergency room <24h, or hospitalization >24 hours.
A higher proportion is worse than a lower proportion
Measured: From Week 0 to Week 12
Proportion of Subjects Deceased From Any Cause Through Week 12.
This will be assessed by probing the subjects at each visit, including caretakers or relatives if the subjects cannot be reached at a given visit.
A higher proportion is worse than a lower proportion
Measured: From Week 0 to Week 12
Proportion of Subjects With Significant Cardiovascular Events
A significant cardiovascular event is one that results in at least an acute care visit, a hospitalization or an event-related death.
A higher proportion is worse than a lower proportion
Measured: From Week 0 to Week 12 and including up to the long-term follow-up at Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start15 Nov 2023
- Primary completion5 Aug 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel, regimen-finding, adaptive design well-controlled randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laurent Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Marie Houle, PhD, Study director, Laurent Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999435
- Sponsor's protocol ID
- LAU-23-01
- Acronym
- ESSOR
- Status last verified
- Dec 2025
- First submitted
- 11 Aug 2023
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, ADAPTIVE PHASE 2/3 STUDY OF THE EFFICACY OF LAU-7b IN THE TREATMENT OF ADULTS WITH LONG COVID AND MODERATE TO SEVERE SYMPTOMS
- ClinicalTrials.gov ID
- NCT05999435
- Acronym / sponsor ID
- ESSOR / LAU-23-01
- Conditions
- Long COVID
- Keywords
- Long COVID, COVID-19, Antiviral, Inflammation control
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Laurent Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Posted 6 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel, regimen-finding, adaptive design well-controlled randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| LAU-7b for 3 cycles | Experimental | Drug: LAU-7b for 3 cyclesEach 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 | Experimental | Drug: LAU-7b for 1 cycle, then placeboEach 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 | Placebo comparator | Other: Placebo for 3 cyclesEach study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAU-7b for 3 cyclesAlso: fenretinideThree cycles of 14 days of once-a-day intake of LAU-7b, each followed by a treatment intake pause of 14 days. | Drug | LAU-7b for 3 cycles |
| LAU-7b for 1 cycle, then placeboAlso: fenretinideOne 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. | Drug | LAU-7b for 1 cycle, then placebo |
| Placebo for 3 cyclesAlso: sugar pillThree cycles of 14 days of once-a-day intake of placebo, each followed by a treatment intake pause of 14 days | Other | Placebo for 3 cycles |
Primary outcome
Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Week 12
Time frame: Week 0 and 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.
19 secondary outcomes
Safety of LAU-7b, Overview
Time frame: From Week 0 to Week 12
Patient Global Impression of Change (PGI-C)
Time frame: Weeks 4, 8 and 12
Proportion of Participants With Marked Improvement in PGI-C
Time frame: Weeks 4, 8 and 12
Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale
Time frame: Weeks 0, 4, 8 and 12
Change From Baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ)
Time frame: Weeks 0 and 12
Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8
Time frame: Weeks 0, 4 and 8
Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36)
Time frame: Weeks 0, 4, 8 and 12
Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection.
Time frame: From Week 0 through Weeks 4, 8 and 12
Proportion of Subjects Achieving >=25% (>=50% and >=75% Presented Separately) Improvement in the Sum of Individual Core Long COVID Symptom Severity as Evaluated by a Standard 4-level Likert Scale.
Time frame: Weeks 4, 8 and 12
Proportion of Subjects Achieving >=50% (>=25% and >=75% Presented Separately) Improvement in the Sum of Individual Core Long COVID Symptom Severity as Evaluated by a Standard 4-level Likert Scale.
Time frame: Weeks 4, 8 and 12
Proportion of Subjects Achieving >=75% (>=25% and >=50% Presented Separately) Improvement in the Sum of Individual Core Long COVID Symptom Severity as Evaluated by a Standard 4-level Likert Scale.
Time frame: Weeks 4, 8 and 12
Change From Baseline in the EuroQol-5 Dimensions -5 Levels (EQ-5D-5L) Score
Time frame: Weeks 0, 4, 8 and 12
Proportion of Subjects With Relief of at Least One Core Burdensome Long COVID Symptom for a Minimum of 2 Weeks.
Time frame: From Week 0 to Week 12
Time to Relief of the First Core Burdensome Long COVID Symptom for a Minimum of 2 Weeks, Among Those Symptoms Present at Baseline.
Time frame: From Week 0 to Week 12
Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms.
Time frame: Weeks 4, 8 and 12
Change From Baseline in the Total Number of Long COVID Symptoms (Core and Non-core).
Time frame: Weeks 0, 4, 8 and 12, as well as the longer term visit at Week 24
Proportion of Subjects With Long COVID-related Unplanned Medical Visits
Time frame: From Week 0 to Week 12
Proportion of Subjects Deceased From Any Cause Through Week 12.
Time frame: From Week 0 to Week 12
Proportion of Subjects With Significant Cardiovascular Events
Time frame: From Week 0 to Week 12 and including up to the long-term follow-up at Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marie Houle, PhD study director
Laurent Pharmaceuticals Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing LAU-7b for 3 cycles in people with Long COVID, run by Laurent Pharmaceuticals Inc. at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Week 12 (time frame: Week 0 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.