Clinical trial NCT05999435: Study of LAU-7b for the Treatment of Long COVID in Adults
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Long COVID
Keywords: Long COVID
COVID-19
Antiviral
Inflammation control
Lead sponsor: Laurent Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-21
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel, regimen-finding, adaptive design well-controlled randomized clinical trial
Primary purpose: TREATMENT

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.

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.

Eligibility 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).

Primary outcomes:
measure: Change from baseline in Physical Functioning Score (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Week 12
timeFrame: Week 0 and 12
Secondary outcomes:
measure: Safety of LAU-7b
timeFrame: From Week 0 to Week 12
measure: Patient Global Impression of Change
timeFrame: Weeks 4, 8 and 12
measure: Change from baseline in the FACIT-Fatigue scale
timeFrame: Weeks 0, 4, 8 and 12
measure: Change from baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ)
timeFrame: Weeks 0 and 12
measure: Change from baseline in Physical Functioning Score (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8
timeFrame: Weeks 0, 4 and 8
measure: Change from baseline in the other aspects than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36)
timeFrame: Weeks 0, 4, 8 and 12
measure: Proportion of subjects who judge to have regained their daily usual activity level of pre-causative-infection.
timeFrame: From Week 0 through Weeks 4, 8 and 12
measure: Proportion of subjects achieving >=25%, >=50% or >=75% improvement in the sum of individual Core Long COVID symptom severity as evaluated by a standard 4-level Likert scale.
timeFrame: Weeks 4, 8 and 12
measure: Change from baseline in the EQ-5D-5L score
timeFrame: Weeks 0, 4, 8 and 12
measure: Proportion of subjects with relief of at least one core Long COVID symptom for a minimum of 2 weeks.
timeFrame: From Week 0 to Week 12
measure: Time to relief of the first core Long COVID symptom for a minimum of 2 weeks, among those symptoms present at baseline.
timeFrame: From Week 0 to Week 12
measure: Proportion of subjects with a sustained clinical recovery, meaning a relief (as defined in outcome #11) of all core Long COVID symptoms.
timeFrame: Weeks 4, 8 and 12
measure: Change from baseline in the total number of Long COVID symptoms (core and non-core).
timeFrame: Weeks 0, 4, 8 and 12
measure: Proportion of subjects with Long COVID-related unplanned medical visits
timeFrame: From Week 0 to Week 12
measure: Proportion of subjects deceased from any cause through Week 12.
timeFrame: From Week 0 to Week 12
measure: Proportion of subjects with significant cardiovascular events
timeFrame: From Week 0 to Week 12
Other outcomes:
measure: Health and survival follow-up 1
timeFrame: Week 24
measure: Health and survival follow-up 2
timeFrame: Week 24
measure: Changes relative to baseline (percent change) of systemic biomarkers of hematologic, inflammation and immunologic functions
timeFrame: Weeks 0, 2 and 10
Locations:
city: Chicoutimi
country: Canada
facility: CIUSS du Saguenay-Lac-St-Jean - Hôpital Chicoutimi
state: Quebec
city: Montréal
country: Canada
facility: Institut de Recherches Cliniques de Montréal
state: Quebec
city: Montréal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier de l'Université de Sherbrooke
state: Quebec
city: Québec
country: Canada
facility: Diex Recherche Québec Inc.
Study officials:
affiliation: Laurent Pharmaceuticals Inc.
name: Jean-Marie Houle, PhD
role: STUDY_DIRECTOR
References: