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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 8
- 主要终点
- Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Week 12
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Identically appearing active and placebo capsules
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: LAU-7b for 3 cycles (Drug)
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.
干预措施: LAU-7b for 1 cycle, then placebo (Drug)
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.
干预措施: Placebo for 3 cycles (Other)
结局指标
主要结局
Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Week 12
时间窗: 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.
次要结局
- 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)
- Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36)(Weeks 0, 4, 8 and 12)
- Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection.(From Week 0 through Weeks 4, 8 and 12)
- Time to Relief of the First Core Burdensome Long COVID Symptom for a Minimum of 2 Weeks, Among Those Symptoms Present at Baseline.(From Week 0 to Week 12)
- Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8(Weeks 0, 4 and 8)
- 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.(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.(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.(Weeks 4, 8 and 12)
- Proportion of Subjects Deceased From Any Cause Through Week 12.(From Week 0 to Week 12)
- Proportion of Subjects With Significant Cardiovascular Events(From Week 0 to Week 12 and including up to the long-term follow-up at Week 24)
- Change From Baseline in the EuroQol-5 Dimensions -5 Levels (EQ-5D-5L) Score(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.(From Week 0 to Week 12)
- Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms.(Weeks 4, 8 and 12)
- Change From Baseline in the Total Number of Long COVID Symptoms (Core and Non-core).(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(From Week 0 to Week 12)