Long COVID
Conditions
Keywords
Long COVID, COVID-19, Antiviral, Inflammation control
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.
Interventions
DRUGLAU-7b for 3 cycles
Three cycles of 14 days of once-a-day intake of LAU-7b, each followed by a treatment intake pause of 14 days.
DRUGLAU-7b for 1 cycle, then placebo
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.
OTHERPlacebo for 3 cycles
Three cycles of 14 days of once-a-day intake of placebo, each followed by a treatment intake pause of 14 days
Sponsors
Laurent Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Identically appearing active and placebo capsules
Intervention model description
Parallel, regimen-finding, adaptive design well-controlled randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Weeks 0, 4, 8 and 12 | 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. |
| 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 | 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. |
| 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 | 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 |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| Change From Baseline in the EuroQol-5 Dimensions -5 Levels (EQ-5D-5L) Score | Weeks 0, 4, 8 and 12 | 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. |
| 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 | 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) |
| 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 | 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. |
| Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms. | Weeks 4, 8 and 12 | 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. |
| 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 | 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. |
| Proportion of Subjects With Long COVID-related Unplanned Medical Visits | From Week 0 to Week 12 | 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 |
| Proportion of Subjects Deceased From Any Cause Through Week 12. | From Week 0 to 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 |
| Safety of LAU-7b, Overview | From Week 0 to Week 12 | 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. |
| Patient Global Impression of Change (PGI-C) | Weeks 4, 8 and 12 | 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. |
| Proportion of Participants With Marked Improvement in PGI-C | Weeks 4, 8 and 12 | 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. |
| Change From Baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ) | Weeks 0 and 12 | 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. |
| 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Baseline Values of Systemic Biomarkers of Hematologic Function (Except Hemoglobin & Hematocrit) | Week 0 | These will be assessed by blood samples taken at randomization visit in a subgroup of participants consented to contribute samples. |
| Baseline Values of Systemic Biomarkers of Hematologic Function (Hemoglobin) | Week 0 | These will be assessed by blood samples taken at randomization visit in a subgroup of participants consented to contribute samples. |
| Baseline Values of Systemic Biomarkers of Hematologic Function (Hematocrit) | Week 0 | These will be assessed by blood samples taken at randomization visit in a subgroup of participants consented to contribute samples. |
| Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Weeks 0, 2 and 10 | These will be assessed by blood samples taken at specific visits of the study in a subgroup of participants consented to contribute samples. |
| Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Week 0 | These will be assessed by blood samples taken at randomization visits of the study in a subgroup of participants consented to contribute samples. |
| Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Calprotectin, C-reactive Protein) | Week 0 | These will be assessed by blood samples taken at randomization visits of the study in a subgroup of participants consented to contribute samples. |
| Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Serotonin, Tryptophan and Taurine) | Week 0 | These will be assessed by blood samples taken at randomization visits of the study in a subgroup of participants consented to contribute samples. |
| Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Weeks 0, 2 and 10 | These will be assessed by blood samples taken at specific visits of the study in a subgroup of participants consented to contribute samples. |
| Biomarkers of Pharmacodynamic Activity - Plasma Retinol | Weeks 0, 2 and 10 | These will be assessed by blood samples taken at specific visits of the study in a subgroup of participants consented to contribute samples. |
| Biomarkers of Pharmacodynamic Activity - Systematic Inflammation Index (SII) | Weeks 0, 2 and 10 | These will be assessed by blood samples taken at specific visits of the study in a subgroup of participants consented to contribute samples. SII = (N × P)/L, where N, P and L (cells\*10\^9/L) represent absolute neutrophil counts, platelet counts and lymphocyte counts. Since SII is a ratio of concentrations, it is unitless. |
| Changes Relative to Baseline (Percent Change) of Biomarker of Pharmacodynamic Activity - Retinol | Weeks 0, 2 and 10 | These will be assessed by blood samples taken at specific visits of the study in a subgroup of participants consented to contribute samples. |
| Health and Survival Follow-up (Week 24), Significant Cardiovascular Events | Week 24 | General health check-up: Assess significant cardiovascular events (one that results in at least an acute care visit, a hospitalization or an event-related death) and survival. |
| Health and Survival Follow-up (Week 24), Long COVID Symptom Count | Week 24 | This is now presented as part of Outcome #17. Initially planned to be separate from the reporting and analysis of the Week 12 outcomes, a longer term contact was made at Week 24 to assess the following: Presence or not of Long COVID symptoms (total number of Long COVID symptoms). |
Countries
Canada
Participant flow
Recruitment details
The study was conducted at 5 specialized Long COVID medical clinics in Quebec. A total of 285 potential participants were screened from 15 November 2023 to 07 May 2024
Participants by arm
| Arm | Count |
|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) Three cycles of 14 days of once-a-day intake of LAU-7b, each followed by a treatment intake pause of 14 days. | 91 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) 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. | 91 |
| Placebo for 3 Cycles (Arm 3, PPP) Three cycles of 14 days of once-a-day intake of placebo, each followed by a treatment intake pause of 14 days | 90 |
| Total | 272 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) | LAU-7b for 3 Cycles (Arm 1, AAA) | Total |
|---|---|---|---|---|
| Age, Continuous | 46.8 years STANDARD_DEVIATION 10.96 | 46.5 years STANDARD_DEVIATION 10.08 | 49.9 years STANDARD_DEVIATION 9.26 | 47.8 years STANDARD_DEVIATION 10.2 |
| Age, Customized Age categories 18 to 44 years | 40 Participants | 37 Participants | 24 Participants | 101 Participants |
| Age, Customized Age categories 45 to 54 years | 33 Participants | 34 Participants | 39 Participants | 106 Participants |
| Age, Customized Age categories Equal or greater than 55 years | 18 Participants | 19 Participants | 28 Participants | 65 Participants |
| Body Mass Index (BMI) | 27.91 kilograms/square meter STANDARD_DEVIATION 6.29 | 29.54 kilograms/square meter STANDARD_DEVIATION 7.82 | 28.14 kilograms/square meter STANDARD_DEVIATION 7.07 | 28.53 kilograms/square meter STANDARD_DEVIATION 7.1 |
| Body Weight | 75.98 kilograms STANDARD_DEVIATION 17.375 | 81.88 kilograms STANDARD_DEVIATION 23.682 | 77.18 kilograms STANDARD_DEVIATION 18.972 | 78.34 kilograms STANDARD_DEVIATION 20.264 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 89 Participants | 88 Participants | 91 Participants | 268 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 90 Participants | 89 Participants | 90 Participants | 269 Participants |
| Region of Enrollment Canada | 91 participants | 90 participants | 91 participants | 272 participants |
| Sex: Female, Male Female | 78 Participants | 74 Participants | 76 Participants | 228 Participants |
| Sex: Female, Male Male | 13 Participants | 16 Participants | 15 Participants | 44 Participants |
| Vaccinated against Coronavirus Disease 2019 (COVID-19) Non-vaccinated | 10 Participants | 5 Participants | 4 Participants | 19 Participants |
| Vaccinated against Coronavirus Disease 2019 (COVID-19) Vaccinated | 81 Participants | 85 Participants | 87 Participants | 253 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 91 | 0 / 90 |
| other Total, other adverse events | 71 / 90 | 71 / 91 | 59 / 90 |
| serious Total, serious adverse events | 1 / 90 | 2 / 91 | 2 / 90 |
Outcome results
Primary
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.
Time frame: Week 0 and 12
Population: Intent-to-Treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Week 12 | PCS at Week 12 | 29.47 score on a scale | Standard Deviation 9.267 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Week 12 | Change from Baseline PCS | 1.94 score on a scale | Standard Deviation 8.034 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Week 12 | PCS at Week 12 | 29.90 score on a scale | Standard Deviation 7.941 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Week 12 | Change from Baseline PCS | 3.32 score on a scale | Standard Deviation 7.777 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Week 12 | PCS at Week 12 | 30.06 score on a scale | Standard Deviation 9.484 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Week 12 | Change from Baseline PCS | 2.78 score on a scale | Standard Deviation 8.298 |
Comparison: Null hypothesis of no difference; statistical results of observed PCS and change from baseline PCS are identical.p-value: 0.4463Mixed Models Analysis
Comparison: Null hypothesis of no difference; statistical results of observed PCS and change from baseline PCS are identical.p-value: 0.8707Mixed Models Analysis
Comparison: Null hypothesis of no difference; statistical results of observed PCS and change from baseline PCS are identical.p-value: 0.36Mixed Models Analysis
Secondary
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.
Time frame: Weeks 0, 4 and 8
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8 | PCS at Week 4 | 28.71 units on a scale | Standard Deviation 6.934 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8 | Change from baseline PCS at Week 4 | 1.26 units on a scale | Standard Deviation 6.95 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8 | PCS at Week 8 | 30.35 units on a scale | Standard Deviation 9.333 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8 | Change from baseline PCS at Week 8 | 2.64 units on a scale | Standard Deviation 8.806 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8 | Change from baseline PCS at Week 8 | 2.81 units on a scale | Standard Deviation 7.117 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8 | PCS at Week 4 | 29.18 units on a scale | Standard Deviation 8.35 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8 | PCS at Week 8 | 29.39 units on a scale | Standard Deviation 8.295 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8 | Change from baseline PCS at Week 4 | 2.89 units on a scale | Standard Deviation 7.514 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8 | Change from baseline PCS at Week 8 | 2.28 units on a scale | Standard Deviation 7.897 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8 | Change from baseline PCS at Week 4 | 1.05 units on a scale | Standard Deviation 7.661 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8 | PCS at Week 8 | 29.64 units on a scale | Standard Deviation 9.051 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in Physical Component Summary (PCS) of the Medical Outcomes Study Short-Form-36 (SF-36) at Weeks 4 and 8 | PCS at Week 4 | 28.20 units on a scale | Standard Deviation 8.767 |
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 0.7052Mixed Models Analysis
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 0.115Mixed Models Analysis
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 0.2296Mixed Models Analysis
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 0.7761Mixed Models Analysis
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 0.8544Mixed Models Analysis
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 0.9197Mixed Models Analysis
Secondary
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.
Time frame: Weeks 0 and 12
Population: ITT population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ) | Baseline | Participants with PEM | 81 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ) | Baseline | Participants without PEM | 7 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ) | Week 12 | Participants with PEM | 80 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ) | Week 12 | Participants without PEM | 7 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ) | Week 12 | Participants without PEM | 8 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ) | Baseline | Participants with PEM | 87 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ) | Week 12 | Participants with PEM | 82 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ) | Baseline | Participants without PEM | 3 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ) | Week 12 | Participants without PEM | 7 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ) | Baseline | Participants without PEM | 6 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ) | Week 12 | Participants with PEM | 83 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the DePaul Post-Exertional Malaise Questionnaire (DPEMQ) | Baseline | Participants with PEM | 84 Participants |
Comparison: Baseline comparison, null hypothesis of no differencep-value: 0.7807Fisher Exact
Comparison: Baseline comparison, null hypothesis of no differencep-value: 0.4965Fisher Exact
Comparison: Baseline comparison, null hypothesis of no differencep-value: 0.2093Fisher Exact
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 1Fisher Exact
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 1Fisher Exact
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 1Fisher Exact
Secondary
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.
Time frame: Weeks 0, 4, 8 and 12
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the EuroQol-5 Dimensions -5 Levels (EQ-5D-5L) Score | Baseline Summary Index | 0.60 score on a scale | Standard Deviation 0.195 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the EuroQol-5 Dimensions -5 Levels (EQ-5D-5L) Score | Change from baseline at Week 4 | 0.01 score on a scale | Standard Deviation 0.178 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the EuroQol-5 Dimensions -5 Levels (EQ-5D-5L) Score | Change from baseline at Week 8 | 0.03 score on a scale | Standard Deviation 0.158 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the EuroQol-5 Dimensions -5 Levels (EQ-5D-5L) Score | Change from baseline at Week 12 | 0.04 score on a scale | Standard Deviation 0.15 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the EuroQol-5 Dimensions -5 Levels (EQ-5D-5L) Score | Change from baseline at Week 12 | 0.03 score on a scale | Standard Deviation 0.168 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the EuroQol-5 Dimensions -5 Levels (EQ-5D-5L) Score | Baseline Summary Index | 0.56 score on a scale | Standard Deviation 0.209 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the EuroQol-5 Dimensions -5 Levels (EQ-5D-5L) Score | Change from baseline at Week 8 | 0.02 score on a scale | Standard Deviation 0.188 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the EuroQol-5 Dimensions -5 Levels (EQ-5D-5L) Score | Change from baseline at Week 4 | 0.03 score on a scale | Standard Deviation 0.164 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the EuroQol-5 Dimensions -5 Levels (EQ-5D-5L) Score | Change from baseline at Week 12 | 0.08 score on a scale | Standard Deviation 0.187 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the EuroQol-5 Dimensions -5 Levels (EQ-5D-5L) Score | Change from baseline at Week 4 | 0.04 score on a scale | Standard Deviation 0.15 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the EuroQol-5 Dimensions -5 Levels (EQ-5D-5L) Score | Change from baseline at Week 8 | 0.03 score on a scale | Standard Deviation 0.174 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the EuroQol-5 Dimensions -5 Levels (EQ-5D-5L) Score | Baseline Summary Index | 0.58 score on a scale | Standard Deviation 0.213 |
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 0.4156Mixed Models Analysis
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 0.7088Mixed Models Analysis
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 0.661Mixed Models Analysis
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 0.758Mixed Models Analysis
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 0.4974Mixed Models Analysis
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 0.3289Mixed Models Analysis
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 0.17Mixed Models Analysis
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 0.0557Mixed Models Analysis
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 0.6008Mixed Models Analysis
Secondary
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.
Time frame: Weeks 0, 4, 8 and 12
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Value at Week 4 | 20.28 units on a scale | Standard Deviation 11.524 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Change from baseline at Week 8 | 5.94 units on a scale | Standard Deviation 8.535 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Value at Week 8 | 21.67 units on a scale | Standard Deviation 12.426 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Value at baseline | 15.68 units on a scale | Standard Deviation 8.141 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Change from baseline at Week 12 | 5.07 units on a scale | Standard Deviation 8.507 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Value at Week 12 | 20.63 units on a scale | Standard Deviation 11.914 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Change from baseline at Week 4 | 4.70 units on a scale | Standard Deviation 8.535 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Value at Week 8 | 18.20 units on a scale | Standard Deviation 9.309 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Value at baseline | 15.18 units on a scale | Standard Deviation 6.94 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Value at Week 4 | 17.77 units on a scale | Standard Deviation 9.499 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Change from baseline at Week 4 | 2.67 units on a scale | Standard Deviation 7.005 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Change from baseline at Week 8 | 3.14 units on a scale | Standard Deviation 8.099 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Value at Week 12 | 19.07 units on a scale | Standard Deviation 9.547 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Change from baseline at Week 12 | 4.07 units on a scale | Standard Deviation 7.998 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Change from baseline at Week 8 | 3.29 units on a scale | Standard Deviation 9.057 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Value at Week 4 | 19.33 units on a scale | Standard Deviation 9.93 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Change from baseline at Week 12 | 5.73 units on a scale | Standard Deviation 10.749 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Value at Week 12 | 22.19 units on a scale | Standard Deviation 11.082 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Value at Week 8 | 19.60 units on a scale | Standard Deviation 10.14 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Change from baseline at Week 4 | 2.91 units on a scale | Standard Deviation 8.103 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale | Value at baseline | 16.48 units on a scale | Standard Deviation 8.456 |
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 0.2217Mixed Models Analysis
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 0.6834Mixed Models Analysis
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 0.1061Mixed Models Analysis
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 0.0854Mixed Models Analysis
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 0.6686Mixed Models Analysis
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 0.0331Mixed Models Analysis
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 0.4327Mixed Models Analysis
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 0.1247Mixed Models Analysis
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 0.4606Mixed Models Analysis
Secondary
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.
Time frame: Weeks 0, 4, 8 and 12
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline bodily pain score | 35.7 units on a scale | Standard Deviation 24.45 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline vitality score at Week 4 | 7.6 units on a scale | Standard Deviation 16.64 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline vitality score at Week 8 | 10.6 units on a scale | Standard Deviation 18.25 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline vitality score at Week 12 | 7.1 units on a scale | Standard Deviation 17.78 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline physical functioning score | 42.8 units on a scale | Standard Deviation 22.85 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline physical functioning score at Week 4 | -0.5 units on a scale | Standard Deviation 21.19 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline physical functioning score at Week 8 | 3.9 units on a scale | Standard Deviation 24.65 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline physical functioning score at Week 12 | 3.1 units on a scale | Standard Deviation 26.71 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline vitality score | 17.6 units on a scale | Standard Deviation 14.36 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline bodily pain score at Week 4 | 2.4 units on a scale | Standard Deviation 20.5 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline bodily pain score at Week 8 | 6.2 units on a scale | Standard Deviation 19.87 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline bodily pain score at Week 12 | 4.1 units on a scale | Standard Deviation 18.92 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline general health perception score | 30.0 units on a scale | Standard Deviation 15.8 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline general health perception score at Week 4 | 3.6 units on a scale | Standard Deviation 11.85 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline general health perception score at Week 8 | 5.1 units on a scale | Standard Deviation 13.85 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline general health perception score at Week 12 | 5.4 units on a scale | Standard Deviation 14.57 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline physical role functioning score | 1.7 units on a scale | Standard Deviation 8.3 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline physical role functioning score at Week 4 | 3.0 units on a scale | Standard Deviation 17.2 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline physical role functioning score at Week 8 | 7.5 units on a scale | Standard Deviation 23.01 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline physical role functioning score at Week 12 | 2.9 units on a scale | Standard Deviation 17 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline emotional role functioning | 47.0 units on a scale | Standard Deviation 45.38 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline emotional role functioning score at Week 4 | -2.4 units on a scale | Standard Deviation 44.41 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline emotional role functioning score at Week 8 | 6.4 units on a scale | Standard Deviation 49.79 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline emotional role functioning score at Week 12 | 1.6 units on a scale | Standard Deviation 48.5 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline social role functioning score | 23.9 units on a scale | Standard Deviation 19.66 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline social role functioning score at Week 4 | 5.6 units on a scale | Standard Deviation 18.95 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline social role functioning score at Week 8 | 10.4 units on a scale | Standard Deviation 20.08 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline social role functioning score at Week 12 | 10.4 units on a scale | Standard Deviation 21.12 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline mental health score | 55.7 units on a scale | Standard Deviation 6.28 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline mental health score at Week 4 | 1.0 units on a scale | Standard Deviation 7.04 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline mental health score at Week 8 | 0.7 units on a scale | Standard Deviation 6.89 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline mental health score at Week 12 | 1.0 units on a scale | Standard Deviation 7.66 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline emotional role functioning score at Week 4 | -10.3 units on a scale | Standard Deviation 45.4 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline vitality score | 14.8 units on a scale | Standard Deviation 12.55 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline general health perception score at Week 4 | 2.0 units on a scale | Standard Deviation 11.2 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline physical role functioning score | 0.8 units on a scale | Standard Deviation 4.54 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline vitality score at Week 4 | 7.2 units on a scale | Standard Deviation 14.61 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline general health perception score | 31.4 units on a scale | Standard Deviation 14.96 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline mental health score at Week 8 | -0.2 units on a scale | Standard Deviation 7.4 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline vitality score at Week 8 | 5.8 units on a scale | Standard Deviation 14.74 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline physical role functioning score at Week 4 | 4.5 units on a scale | Standard Deviation 16.99 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline emotional role functioning score at Week 8 | -6.7 units on a scale | Standard Deviation 46.8 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline vitality score at Week 12 | 6.9 units on a scale | Standard Deviation 14.23 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline mental health score at Week 12 | -0.0 units on a scale | Standard Deviation 8.45 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline social role functioning score at Week 12 | 7.6 units on a scale | Standard Deviation 20.15 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline physical functioning score | 38.1 units on a scale | Standard Deviation 20.55 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline physical role functioning score at Week 8 | 5.0 units on a scale | Standard Deviation 18.82 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline general health perception score at Week 8 | 1.9 units on a scale | Standard Deviation 11.66 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline physical functioning score at Week 4 | 5.8 units on a scale | Standard Deviation 21.36 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline bodily pain score at Week 12 | 4.2 units on a scale | Standard Deviation 18.35 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline emotional role functioning score at Week 12 | -6.6 units on a scale | Standard Deviation 43.93 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline physical functioning score at Week 8 | 4.8 units on a scale | Standard Deviation 23.31 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline physical role functioning score at Week 12 | 2.3 units on a scale | Standard Deviation 11.9 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline social role functioning score at Week 8 | 5.4 units on a scale | Standard Deviation 18.94 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline physical functioning score at Week 12 | 8.0 units on a scale | Standard Deviation 26.95 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline general health perception score at Week 12 | 3.4 units on a scale | Standard Deviation 13.33 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline mental health score at Week 4 | -0.2 units on a scale | Standard Deviation 7.62 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline bodily pain score | 37.5 units on a scale | Standard Deviation 23.44 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline emotional role functioning | 55.8 units on a scale | Standard Deviation 46 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline social role functioning score | 23.3 units on a scale | Standard Deviation 19.06 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline bodily pain score at Week 4 | 0.4 units on a scale | Standard Deviation 21.16 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline social role functioning score at Week 4 | 3.9 units on a scale | Standard Deviation 17.56 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline mental health score | 56.1 units on a scale | Standard Deviation 8.11 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline bodily pain score at Week 8 | 3.0 units on a scale | Standard Deviation 20.85 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline physical functioning score at Week 12 | 4.6 units on a scale | Standard Deviation 25.69 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline mental health score at Week 4 | 1.3 units on a scale | Standard Deviation 7.98 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline bodily pain score at Week 12 | 12.0 units on a scale | Standard Deviation 24.68 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline general health perception score | 31.8 units on a scale | Standard Deviation 16.65 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline social role functioning score at Week 4 | 4.4 units on a scale | Standard Deviation 16.82 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline general health perception score at Week 4 | 0.8 units on a scale | Standard Deviation 12.45 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline general health perception score at Week 8 | 1.2 units on a scale | Standard Deviation 13.05 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline general health perception score at Week 12 | 2.3 units on a scale | Standard Deviation 14.61 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline social role functioning score at Week 8 | 7.2 units on a scale | Standard Deviation 19.15 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline physical role functioning score | 3.7 units on a scale | Standard Deviation 14.45 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline physical role functioning score at Week 4 | 3.0 units on a scale | Standard Deviation 23.37 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline physical role functioning score at Week 8 | 6.4 units on a scale | Standard Deviation 26.3 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline social role functioning score at Week 12 | 9.3 units on a scale | Standard Deviation 23.75 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline physical role functioning score at Week 12 | 4.3 units on a scale | Standard Deviation 20.95 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline mental health score at Week 8 | 0.7 units on a scale | Standard Deviation 7.09 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline emotional role functioning | 51.5 units on a scale | Standard Deviation 44.61 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline vitality score | 18.8 units on a scale | Standard Deviation 14.61 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline emotional role functioning score at Week 4 | -5.3 units on a scale | Standard Deviation 38.66 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline vitality score at Week 4 | 3.9 units on a scale | Standard Deviation 15.38 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline mental health score | 56.2 units on a scale | Standard Deviation 8.05 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline vitality score at Week 8 | 6.2 units on a scale | Standard Deviation 18.54 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline vitality score at Week 12 | 7.8 units on a scale | Standard Deviation 19.64 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline emotional role functioning score at Week 8 | -0.4 units on a scale | Standard Deviation 44.9 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline physical functioning score | 41.6 units on a scale | Standard Deviation 23.68 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline mental health score at Week 12 | -0.1 units on a scale | Standard Deviation 7.92 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline physical functioning score at Week 4 | -1.7 units on a scale | Standard Deviation 22.09 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline physical functioning score at Week 8 | 2.2 units on a scale | Standard Deviation 25.05 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline emotional role functioning score at Week 12 | 6.9 units on a scale | Standard Deviation 43.37 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline bodily pain score at Week 8 | 6.3 units on a scale | Standard Deviation 17.94 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline bodily pain score | 35.3 units on a scale | Standard Deviation 22.04 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Change from baseline bodily pain score at Week 4 | 3.7 units on a scale | Standard Deviation 15.09 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Other Aspects (Domain Scales) Than the PCS of the Medical Outcomes Study Short-Form-36 (SF-36) | Baseline social role functioning score | 26.6 units on a scale | Standard Deviation 19.68 |
Comparison: Vitality domain, Week 12 comparison, null hypothesis of no differencep-value: 0.6269Mixed Models Analysis
Comparison: Vitality domain, Week 12 comparison, null hypothesis of no differencep-value: 0.4427Mixed Models Analysis
Comparison: Vitality domain, Week 12 comparison, null hypothesis of no differencep-value: 0.7783Mixed Models Analysis
Comparison: Physical Functioning domain, Week 12 comparison, null hypothesis of no differencep-value: 0.7488Mixed Models Analysis
Comparison: Physical Functioning domain, Week 12 comparison, null hypothesis of no differencep-value: 0.5557Mixed Models Analysis
Comparison: Physical Functioning domain, Week 12 comparison, null hypothesis of no differencep-value: 0.3679Mixed Models Analysis
Comparison: Bodily Pain domain, Week 12 comparison, null hypothesis of no differencep-value: 0.0044Mixed Models Analysis
Comparison: Bodily Pain domain, Week 12 comparison, null hypothesis of no differencep-value: 0.0158Mixed Models Analysis
Comparison: Bodily Pain domain, Week 12 comparison, null hypothesis of no differencep-value: 0.6682Mixed Models Analysis
Comparison: General Health domain, Week 12 comparison, null hypothesis of no differencep-value: 0.2448Mixed Models Analysis
Comparison: General Health domain, Week 12 comparison, null hypothesis of no differencep-value: 0.4702Mixed Models Analysis
Comparison: General Health domain, Week 12 comparison, null hypothesis of no differencep-value: 0.6627Mixed Models Analysis
Comparison: Role Physical Functioning domain, Week 12 comparison, null hypothesis of no differencep-value: 0.2774Mixed Models Analysis
Comparison: Role Physical Functioning domain, Week 12 comparison, null hypothesis of no differencep-value: 0.1537Mixed Models Analysis
Comparison: Role Physical Functioning domain, Week 12 comparison, null hypothesis of no differencep-value: 0.7355Mixed Models Analysis
Comparison: Role Emotional Functioning domain, Week 12 comparison, null hypothesis of no differencep-value: 0.1757Mixed Models Analysis
Comparison: Rome Emotional Functioning domain, Week 12 comparison, null hypothesis of no differencep-value: 0.0649Mixed Models Analysis
Comparison: Role Emotional Functioning domain, Week 12 comparison, null hypothesis of no differencep-value: 0.6262Mixed Models Analysis
Comparison: Social Role Functioning domain, Week 12 comparison, null hypothesis of no differencep-value: 0.9709Mixed Models Analysis
Comparison: Social Role Functioning domain, Week 12 comparison, null hypothesis of no differencep-value: 0.3201Mixed Models Analysis
Comparison: Social Role Functioning domain, Week 12 comparison, null hypothesis of no differencep-value: 0.3065Mixed Models Analysis
Comparison: Mental Health domain, Week 12 comparison, null hypothesis of no differencep-value: 0.2891Mixed Models Analysis
Comparison: Mental Health domain, Week 12 comparison, null hypothesis of no differencep-value: 0.8714Mixed Models Analysis
Comparison: Mental Health domain, Week 12 comparison, null hypothesis of no differencep-value: 0.226Mixed Models Analysis
Secondary
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.
Time frame: Weeks 0, 4, 8 and 12, as well as the longer term visit at Week 24
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Total Number of Long COVID Symptoms (Core and Non-core). | Count of all Long COVID symptoms at Week 4 | 14.2 count of symptoms | Standard Deviation 7.06 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Total Number of Long COVID Symptoms (Core and Non-core). | Baseline count of all Long COVID symptoms | 14.3 count of symptoms | Standard Deviation 7.07 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Total Number of Long COVID Symptoms (Core and Non-core). | Count of all Long COVID symptoms at Week 8 | 14.4 count of symptoms | Standard Deviation 7.25 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Total Number of Long COVID Symptoms (Core and Non-core). | Count of all Long COVID symptoms at Week 24 | 14.4 count of symptoms | Standard Deviation 7.26 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Change From Baseline in the Total Number of Long COVID Symptoms (Core and Non-core). | Count of all Long COVID symptoms at Week 12 | 14.4 count of symptoms | Standard Deviation 7.18 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Total Number of Long COVID Symptoms (Core and Non-core). | Count of all Long COVID symptoms at Week 24 | 14.8 count of symptoms | Standard Deviation 8.2 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Total Number of Long COVID Symptoms (Core and Non-core). | Baseline count of all Long COVID symptoms | 15.2 count of symptoms | Standard Deviation 7.98 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Total Number of Long COVID Symptoms (Core and Non-core). | Count of all Long COVID symptoms at Week 4 | 15.1 count of symptoms | Standard Deviation 8.04 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Total Number of Long COVID Symptoms (Core and Non-core). | Count of all Long COVID symptoms at Week 8 | 15.0 count of symptoms | Standard Deviation 8.07 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Change From Baseline in the Total Number of Long COVID Symptoms (Core and Non-core). | Count of all Long COVID symptoms at Week 12 | 15.0 count of symptoms | Standard Deviation 8.05 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Total Number of Long COVID Symptoms (Core and Non-core). | Count of all Long COVID symptoms at Week 8 | 14.9 count of symptoms | Standard Deviation 7.57 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Total Number of Long COVID Symptoms (Core and Non-core). | Baseline count of all Long COVID symptoms | 15.0 count of symptoms | Standard Deviation 7.88 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Total Number of Long COVID Symptoms (Core and Non-core). | Count of all Long COVID symptoms at Week 24 | 14.7 count of symptoms | Standard Deviation 7.65 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Total Number of Long COVID Symptoms (Core and Non-core). | Count of all Long COVID symptoms at Week 4 | 15.0 count of symptoms | Standard Deviation 7.9 |
| Placebo for 3 Cycles (Arm 3, PPP) | Change From Baseline in the Total Number of Long COVID Symptoms (Core and Non-core). | Count of all Long COVID symptoms at Week 12 | 14.9 count of symptoms | Standard Deviation 7.55 |
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 0.7699ANOVA
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 0.9928ANOVA
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 0.8363ANOVA
Comparison: Week 24 comparison, null hypothesis of no differencep-value: 0.693ANOVA
Secondary
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.
Time frame: Weeks 4, 8 and 12
Population: ITT population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | Very much improved | 3 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | Minimally worse | 8 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | Very much worse | 1 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | Much improved | 11 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | Minimally improved | 25 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | Much worse | 2 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | Minimally improved | 23 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | Very much worse | 1 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | Minimally worse | 8 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | No change | 39 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | No change | 43 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | No change | 43 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | Much worse | 2 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | Minimally improved | 18 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | Minimally worse | 6 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | Much improved | 10 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | Much improved | 9 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | Much worse | 2 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | Very much worse | 1 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | Very much improved | 0 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | Very much improved | 7 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | Minimally worse | 5 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | Very much improved | 1 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | Much improved | 3 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | Minimally improved | 25 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | No change | 46 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | Minimally worse | 7 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | Very much worse | 3 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | Very much improved | 0 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | Much improved | 5 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | Minimally improved | 28 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | No change | 42 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | Minimally worse | 8 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | Much worse | 6 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | Very much worse | 0 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | Very much improved | 0 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | Much improved | 5 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | Minimally improved | 37 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | No change | 38 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | Much worse | 3 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | Much worse | 5 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | Very much worse | 0 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | Very much worse | 2 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | Minimally worse | 11 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | Very much improved | 2 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | Minimally worse | 6 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | Very much improved | 1 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | Much improved | 13 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | No change | 47 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | Very much worse | 1 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | Minimally improved | 30 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | Minimally improved | 25 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | Much worse | 4 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | No change | 35 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | Minimally improved | 32 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 12 | No change | 29 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | Minimally worse | 10 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | Much improved | 1 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | Much improved | 3 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | Much worse | 3 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | Very much improved | 3 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 4 | Much worse | 1 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Patient Global Impression of Change (PGI-C) | PGI-C at Week 8 | Very much worse | 1 Participants |
Secondary
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.
Time frame: Weeks 4, 8 and 12
Population: ITT population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Participants With Marked Improvement in PGI-C | Marked improvement of PGI-C at Week 12 | Participants achieving a marked improvement | 16 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Participants With Marked Improvement in PGI-C | Marked improvement of PGI-C at Week 8 | Participants achieving a marked improvement | 14 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Participants With Marked Improvement in PGI-C | Marked improvement of PGI-C at Week 12 | No marked improvement | 72 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Participants With Marked Improvement in PGI-C | Marked improvement of PGI-C at Week 4 | Participants achieving a marked improvement | 10 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Participants With Marked Improvement in PGI-C | Marked improvement of PGI-C at Week 8 | No marked improvement | 73 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Participants With Marked Improvement in PGI-C | Marked improvement of PGI-C at Week 4 | No marked improvement | 77 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Participants With Marked Improvement in PGI-C | Marked improvement of PGI-C at Week 8 | No marked improvement | 84 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Participants With Marked Improvement in PGI-C | Marked improvement of PGI-C at Week 12 | Participants achieving a marked improvement | 5 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Participants With Marked Improvement in PGI-C | Marked improvement of PGI-C at Week 4 | No marked improvement | 84 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Participants With Marked Improvement in PGI-C | Marked improvement of PGI-C at Week 12 | No marked improvement | 85 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Participants With Marked Improvement in PGI-C | Marked improvement of PGI-C at Week 8 | Participants achieving a marked improvement | 5 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Participants With Marked Improvement in PGI-C | Marked improvement of PGI-C at Week 4 | Participants achieving a marked improvement | 4 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Participants With Marked Improvement in PGI-C | Marked improvement of PGI-C at Week 12 | No marked improvement | 75 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Participants With Marked Improvement in PGI-C | Marked improvement of PGI-C at Week 4 | Participants achieving a marked improvement | 4 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Participants With Marked Improvement in PGI-C | Marked improvement of PGI-C at Week 4 | No marked improvement | 81 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Participants With Marked Improvement in PGI-C | Marked improvement of PGI-C at Week 8 | Participants achieving a marked improvement | 4 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Participants With Marked Improvement in PGI-C | Marked improvement of PGI-C at Week 8 | No marked improvement | 81 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Participants With Marked Improvement in PGI-C | Marked improvement of PGI-C at Week 12 | Participants achieving a marked improvement | 15 Participants |
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 0.1618Fisher Exact
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 1Fisher Exact
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 0.1027Fisher Exact
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 0.0229Fisher Exact
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 1Fisher Exact
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 0.0296Fisher Exact
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 0.8448Fisher Exact
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 0.0307Fisher Exact
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 0.0105Fisher Exact
Secondary
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.
Time frame: Weeks 4, 8 and 12
Population: ITT population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | 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. | Week 4 | Participants with at least 25% improvement in burdensome symptoms total score | 10 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | 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. | Week 4 | Participants not reaching 25% improvement in burdensome symptoms total score | 79 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | 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. | Week 8 | Participants with at least 25% improvement in burdensome symptoms total score | 15 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | 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. | Week 8 | Participants not reaching 25% improvement in burdensome symptoms total score | 68 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | 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. | Week 12 | Participants with at least 25% improvement in burdensome symptoms total score | 15 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | 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. | Week 12 | Participants not reaching 25% improvement in burdensome symptoms total score | 70 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | 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. | Week 12 | Participants not reaching 25% improvement in burdensome symptoms total score | 73 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | 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. | Week 4 | Participants with at least 25% improvement in burdensome symptoms total score | 6 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | 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. | Week 8 | Participants not reaching 25% improvement in burdensome symptoms total score | 72 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | 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. | Week 12 | Participants with at least 25% improvement in burdensome symptoms total score | 16 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | 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. | Week 4 | Participants not reaching 25% improvement in burdensome symptoms total score | 84 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | 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. | Week 8 | Participants with at least 25% improvement in burdensome symptoms total score | 18 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | 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. | Week 4 | Participants not reaching 25% improvement in burdensome symptoms total score | 84 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | 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. | Week 8 | Participants with at least 25% improvement in burdensome symptoms total score | 7 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | 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. | Week 12 | Participants not reaching 25% improvement in burdensome symptoms total score | 70 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | 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. | Week 8 | Participants not reaching 25% improvement in burdensome symptoms total score | 81 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | 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. | Week 4 | Participants with at least 25% improvement in burdensome symptoms total score | 6 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | 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. | Week 12 | Participants with at least 25% improvement in burdensome symptoms total score | 18 Participants |
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 0.3081Fisher Exact
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 1Fisher Exact
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 0.3081Fisher Exact
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 0.066Fisher Exact
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 0.0297Fisher Exact
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 0.8471Fisher Exact
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 0.7009Fisher Exact
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 0.7064Fisher Exact
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 1Fisher Exact
Secondary
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.
Time frame: Weeks 4, 8 and 12
Population: ITT population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | 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. | Week 4 | Participants with at least 50% improvement in burdensome symptoms total score | 6 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | 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. | Week 4 | Participants not reaching 50% improvement in burdensome symptoms total score | 83 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | 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. | Week 8 | Participants with at least 50% improvement in burdensome symptoms total score | 9 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | 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. | Week 8 | Participants not reaching 50% improvement in burdensome symptoms total score | 74 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | 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. | Week 12 | Participants with at least 50% improvement in burdensome symptoms total score | 7 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | 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. | Week 12 | Participants not reaching 50% improvement in burdensome symptoms total score | 78 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | 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. | Week 12 | Participants not reaching 50% improvement in burdensome symptoms total score | 86 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | 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. | Week 4 | Participants with at least 50% improvement in burdensome symptoms total score | 1 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | 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. | Week 8 | Participants not reaching 50% improvement in burdensome symptoms total score | 87 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | 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. | Week 12 | Participants with at least 50% improvement in burdensome symptoms total score | 3 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | 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. | Week 4 | Participants not reaching 50% improvement in burdensome symptoms total score | 89 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | 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. | Week 8 | Participants with at least 50% improvement in burdensome symptoms total score | 3 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | 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. | Week 4 | Participants not reaching 50% improvement in burdensome symptoms total score | 88 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | 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. | Week 8 | Participants with at least 50% improvement in burdensome symptoms total score | 4 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | 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. | Week 12 | Participants not reaching 50% improvement in burdensome symptoms total score | 78 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | 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. | Week 8 | Participants not reaching 50% improvement in burdensome symptoms total score | 84 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | 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. | Week 4 | Participants with at least 50% improvement in burdensome symptoms total score | 2 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | 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. | Week 12 | Participants with at least 50% improvement in burdensome symptoms total score | 10 Participants |
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 0.0479Fisher Exact
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 0.1686Fisher Exact
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 1Fisher Exact
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 0.0643Fisher Exact
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 0.1531Fisher Exact
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 0.7187Fisher Exact
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 0.072Fisher Exact
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 0.6117Fisher Exact
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 0.2042Fisher Exact
Secondary
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.
Time frame: Weeks 4, 8 and 12
Population: ITT population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | 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. | Week 4 | Participants with at least 75% improvement in burdensome symptoms total score | 2 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | 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. | Week 4 | Participants not reaching 75% improvement in burdensome symptoms total score | 87 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | 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. | Week 8 | Participants with at least 75% improvement in burdensome symptoms total score | 1 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | 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. | Week 8 | Participants not reaching 75% improvement in burdensome symptoms total score | 82 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | 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. | Week 12 | Participants with at least 75% improvement in burdensome symptoms total score | 1 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | 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. | Week 12 | Participants not reaching 75% improvement in burdensome symptoms total score | 84 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | 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. | Week 12 | Participants not reaching 75% improvement in burdensome symptoms total score | 89 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | 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. | Week 4 | Participants with at least 75% improvement in burdensome symptoms total score | 0 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | 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. | Week 8 | Participants not reaching 75% improvement in burdensome symptoms total score | 90 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | 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. | Week 12 | Participants with at least 75% improvement in burdensome symptoms total score | 0 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | 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. | Week 4 | Participants not reaching 75% improvement in burdensome symptoms total score | 90 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | 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. | Week 8 | Participants with at least 75% improvement in burdensome symptoms total score | 0 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | 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. | Week 4 | Participants not reaching 75% improvement in burdensome symptoms total score | 90 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | 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. | Week 8 | Participants with at least 75% improvement in burdensome symptoms total score | 1 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | 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. | Week 12 | Participants not reaching 75% improvement in burdensome symptoms total score | 87 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | 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. | Week 8 | Participants not reaching 75% improvement in burdensome symptoms total score | 87 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | 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. | Week 4 | Participants with at least 75% improvement in burdensome symptoms total score | 0 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | 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. | Week 12 | Participants with at least 75% improvement in burdensome symptoms total score | 1 Participants |
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 0.2458Fisher Exact
Comparison: Week 4 comparison, null hypothesis of no difference
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 0.2458Fisher Exact
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 1Fisher Exact
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 0.4944Fisher Exact
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 0.4798Fisher Exact
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 1Fisher Exact
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 0.4972Fisher Exact
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 0.4885Fisher Exact
Secondary
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
Time frame: From Week 0 to Week 12
Population: ITT population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Subjects Deceased From Any Cause Through Week 12. | Participants deceased from any cause through Week 12 | 0 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Subjects Deceased From Any Cause Through Week 12. | Participants alive through Week 12 | 91 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Subjects Deceased From Any Cause Through Week 12. | Participants deceased from any cause through Week 12 | 0 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Subjects Deceased From Any Cause Through Week 12. | Participants alive through Week 12 | 91 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Subjects Deceased From Any Cause Through Week 12. | Participants deceased from any cause through Week 12 | 0 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Subjects Deceased From Any Cause Through Week 12. | Participants alive through Week 12 | 90 Participants |
Secondary
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.
Time frame: From Week 0 through Weeks 4, 8 and 12
Population: ITT population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection. | Week 12 | Participants who judge NOT to have regained daily usual activity level | 88 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection. | Week 8 | Participants who judge to have regained daily usual activity level | 0 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection. | Week 12 | Participants who judge to have regained daily usual activity level | 0 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection. | Week 4 | Participants who judge to have regained daily usual activity level | 0 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection. | Week 8 | Participants who judge NOT to have regained daily usual activity level | 88 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection. | Week 4 | Participants who judge NOT to have regained daily usual activity level | 89 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection. | Week 8 | Participants who judge NOT to have regained daily usual activity level | 90 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection. | Week 12 | Participants who judge to have regained daily usual activity level | 1 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection. | Week 4 | Participants who judge NOT to have regained daily usual activity level | 88 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection. | Week 12 | Participants who judge NOT to have regained daily usual activity level | 89 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection. | Week 4 | Participants who judge to have regained daily usual activity level | 3 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection. | Week 8 | Participants who judge to have regained daily usual activity level | 0 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection. | Week 12 | Participants who judge NOT to have regained daily usual activity level | 88 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection. | Week 4 | Participants who judge to have regained daily usual activity level | 0 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection. | Week 4 | Participants who judge NOT to have regained daily usual activity level | 90 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection. | Week 8 | Participants who judge to have regained daily usual activity level | 1 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection. | Week 8 | Participants who judge NOT to have regained daily usual activity level | 89 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Subjects Who Judge to Have Regained Their Daily Usual Activity Level of Pre-causative-infection. | Week 12 | Participants who judge to have regained daily usual activity level | 2 Participants |
Comparison: Week 4 comparison, null hypothesis of no difference
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 0.2459Fisher Exact
Comparison: Week 4 comparison, null hypothesis of no differencep-value: 0.2459Fisher Exact
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 1Fisher Exact
Comparison: Week 8 comparison, null hypothesis of no differencep-value: 1Fisher Exact
Comparison: Week 8 comparison, null hypothesis of no difference
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 0.4972Fisher Exact
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 1Fisher Exact
Comparison: Week 12 comparison, null hypothesis of no differencep-value: 1Fisher Exact
Secondary
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.
Time frame: Weeks 4, 8 and 12
Population: ITT population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms. | Week 4 | Participants achieving sustained recovery of all core symptoms | 0 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms. | Week 4 | Participants NOT achieving sustained recovery of all core symptoms | 89 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms. | Week 8 | Participants achieving sustained recovery of all core symptoms | 0 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms. | Week 8 | Participants NOT achieving sustained recovery of all core symptoms | 88 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms. | Week 12 | Participants achieving sustained recovery of all core symptoms | 0 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms. | Week 12 | Participants NOT achieving sustained recovery of all core symptoms | 88 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms. | Week 12 | Participants NOT achieving sustained recovery of all core symptoms | 90 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms. | Week 4 | Participants achieving sustained recovery of all core symptoms | 0 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms. | Week 8 | Participants NOT achieving sustained recovery of all core symptoms | 90 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms. | Week 12 | Participants achieving sustained recovery of all core symptoms | 0 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms. | Week 4 | Participants NOT achieving sustained recovery of all core symptoms | 91 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms. | Week 8 | Participants achieving sustained recovery of all core symptoms | 0 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms. | Week 4 | Participants NOT achieving sustained recovery of all core symptoms | 90 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms. | Week 8 | Participants achieving sustained recovery of all core symptoms | 0 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms. | Week 12 | Participants NOT achieving sustained recovery of all core symptoms | 90 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms. | Week 8 | Participants NOT achieving sustained recovery of all core symptoms | 90 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms. | Week 4 | Participants achieving sustained recovery of all core symptoms | 0 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Subjects With a Sustained Clinical Recovery, Meaning a Relief of All Core Long COVID Symptoms. | Week 12 | Participants achieving sustained recovery of all core symptoms | 0 Participants |
Comparison: Null hypothesis of no difference
Secondary
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
Time frame: From Week 0 to Week 12
Population: ITT population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Subjects With Long COVID-related Unplanned Medical Visits | Participants with Long COVID-related unplanned medical visits | 2 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Subjects With Long COVID-related Unplanned Medical Visits | Participants without Long COVID-related unplanned medical visits | 89 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Subjects With Long COVID-related Unplanned Medical Visits | Participants with Long COVID-related unplanned medical visits | 3 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Subjects With Long COVID-related Unplanned Medical Visits | Participants without Long COVID-related unplanned medical visits | 88 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Subjects With Long COVID-related Unplanned Medical Visits | Participants with Long COVID-related unplanned medical visits | 5 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Subjects With Long COVID-related Unplanned Medical Visits | Participants without Long COVID-related unplanned medical visits | 85 Participants |
Comparison: Null hypothesis of no differencep-value: 0.278Fisher Exact
Comparison: Null hypothesis of no differencep-value: 0.4967Fisher Exact
Comparison: Null hypothesis of no differencep-value: 1Fisher Exact
Secondary
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)
Time frame: From Week 0 to Week 12
Population: ITT population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Subjects With Relief of at Least One Core Burdensome Long COVID Symptom for a Minimum of 2 Weeks. | Participants with relief of at least one core burdensome symptom | 8 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Subjects With Relief of at Least One Core Burdensome Long COVID Symptom for a Minimum of 2 Weeks. | Participants without relief of core burdensome symptoms | 83 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Subjects With Relief of at Least One Core Burdensome Long COVID Symptom for a Minimum of 2 Weeks. | Participants with relief of at least one core burdensome symptom | 9 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Subjects With Relief of at Least One Core Burdensome Long COVID Symptom for a Minimum of 2 Weeks. | Participants without relief of core burdensome symptoms | 82 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Subjects With Relief of at Least One Core Burdensome Long COVID Symptom for a Minimum of 2 Weeks. | Participants with relief of at least one core burdensome symptom | 9 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Subjects With Relief of at Least One Core Burdensome Long COVID Symptom for a Minimum of 2 Weeks. | Participants without relief of core burdensome symptoms | 81 Participants |
Comparison: Null hypothesis of no differencep-value: 0.8046Fisher Exact
Comparison: Null hypothesis of no differencep-value: 1Fisher Exact
Comparison: Null hypothesis of no differencep-value: 1Fisher Exact
Secondary
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
Time frame: From Week 0 to Week 12 and including up to the long-term follow-up at Week 24
Population: ITT population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Subjects With Significant Cardiovascular Events | Participants with significant cardiovascular event through Week 24 | 0 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Proportion of Subjects With Significant Cardiovascular Events | Participants without significant cardiovascular event through Week 24 | 91 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Subjects With Significant Cardiovascular Events | Participants with significant cardiovascular event through Week 24 | 0 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Proportion of Subjects With Significant Cardiovascular Events | Participants without significant cardiovascular event through Week 24 | 91 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Subjects With Significant Cardiovascular Events | Participants with significant cardiovascular event through Week 24 | 0 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Proportion of Subjects With Significant Cardiovascular Events | Participants without significant cardiovascular event through Week 24 | 90 Participants |
Secondary
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.
Time frame: From Week 0 to Week 12
Population: Safety population includes all participants who received at least one dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Safety of LAU-7b, Overview | Participants with treatment-emergent adverse events with fatal outcome | 0 participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Safety of LAU-7b, Overview | Participants with treatment-emergent adverse events leading to treatment discontinuation | 7 participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Safety of LAU-7b, Overview | Participants with treatment-emergent adverse events | 71 participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Safety of LAU-7b, Overview | Participants with serious treatment-emergent adverse events | 1 participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Safety of LAU-7b, Overview | Participants with suspected unexpected serious adverse reaction (SUSAR) | 0 participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Safety of LAU-7b, Overview | Participants with treatment-emergent adverse events leading to treatment discontinuation | 0 participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Safety of LAU-7b, Overview | Participants with treatment-emergent adverse events | 71 participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Safety of LAU-7b, Overview | Participants with serious treatment-emergent adverse events | 2 participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Safety of LAU-7b, Overview | Participants with treatment-emergent adverse events with fatal outcome | 0 participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Safety of LAU-7b, Overview | Participants with suspected unexpected serious adverse reaction (SUSAR) | 0 participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Safety of LAU-7b, Overview | Participants with suspected unexpected serious adverse reaction (SUSAR) | 0 participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Safety of LAU-7b, Overview | Participants with treatment-emergent adverse events with fatal outcome | 0 participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Safety of LAU-7b, Overview | Participants with treatment-emergent adverse events | 61 participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Safety of LAU-7b, Overview | Participants with treatment-emergent adverse events leading to treatment discontinuation | 1 participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Safety of LAU-7b, Overview | Participants with serious treatment-emergent adverse events | 2 participants |
Secondary
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.
Time frame: From Week 0 to Week 12
Population: ITT population, Incidence rate of relief of at least one core burdensome symptom is less than 10%. Kaplan-Meier analysis and estimates, as well as log-rank test are not reliable and were not performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Time to Relief of the First Core Burdensome Long COVID Symptom for a Minimum of 2 Weeks, Among Those Symptoms Present at Baseline. | 60.13 days | Standard Deviation 19.23 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Time to Relief of the First Core Burdensome Long COVID Symptom for a Minimum of 2 Weeks, Among Those Symptoms Present at Baseline. | 64.78 days | Standard Deviation 19.38 |
| Placebo for 3 Cycles (Arm 3, PPP) | Time to Relief of the First Core Burdensome Long COVID Symptom for a Minimum of 2 Weeks, Among Those Symptoms Present at Baseline. | 71.67 days | Standard Deviation 14.64 |
Other Pre-specified
Baseline Values of Systemic Biomarkers of Hematologic Function (Except Hemoglobin & Hematocrit)
These will be assessed by blood samples taken at randomization visit in a subgroup of participants consented to contribute samples.
Time frame: Week 0
Population: Biomarker subset of participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Hematologic Function (Except Hemoglobin & Hematocrit) | Erythrocyte count (10^9/L) - Baseline | 4496 cells*10^9/L | Standard Deviation 442.2 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Hematologic Function (Except Hemoglobin & Hematocrit) | Leucocyte count (10^9/L) - Baseline | 6.53 cells*10^9/L | Standard Deviation 2.102 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Hematologic Function (Except Hemoglobin & Hematocrit) | Platelet count (10^9/L) - Baseline | 265 cells*10^9/L | Standard Deviation 75.9 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Hematologic Function (Except Hemoglobin & Hematocrit) | Neutrophil count (10^9/L) - Baseline | 4.23 cells*10^9/L | Standard Deviation 1.655 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Hematologic Function (Except Hemoglobin & Hematocrit) | Neutrophil count (10^9/L) - Baseline | 3.59 cells*10^9/L | Standard Deviation 1.307 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Hematologic Function (Except Hemoglobin & Hematocrit) | Erythrocyte count (10^9/L) - Baseline | 4703 cells*10^9/L | Standard Deviation 384.7 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Hematologic Function (Except Hemoglobin & Hematocrit) | Platelet count (10^9/L) - Baseline | 261 cells*10^9/L | Standard Deviation 56.8 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Hematologic Function (Except Hemoglobin & Hematocrit) | Leucocyte count (10^9/L) - Baseline | 5.99 cells*10^9/L | Standard Deviation 1.576 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Hematologic Function (Except Hemoglobin & Hematocrit) | Neutrophil count (10^9/L) - Baseline | 3.95 cells*10^9/L | Standard Deviation 1.369 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Hematologic Function (Except Hemoglobin & Hematocrit) | Leucocyte count (10^9/L) - Baseline | 6.28 cells*10^9/L | Standard Deviation 1.634 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Hematologic Function (Except Hemoglobin & Hematocrit) | Platelet count (10^9/L) - Baseline | 252 cells*10^9/L | Standard Deviation 73.1 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Hematologic Function (Except Hemoglobin & Hematocrit) | Erythrocyte count (10^9/L) - Baseline | 4610 cells*10^9/L | Standard Deviation 431.8 |
Other Pre-specified
Baseline Values of Systemic Biomarkers of Hematologic Function (Hematocrit)
These will be assessed by blood samples taken at randomization visit in a subgroup of participants consented to contribute samples.
Time frame: Week 0
Population: Biomarker subset of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Hematologic Function (Hematocrit) | 0.409 L/L | Standard Deviation 0.0358 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Hematologic Function (Hematocrit) | 0.417 L/L | Standard Deviation 0.0269 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Hematologic Function (Hematocrit) | 0.418 L/L | Standard Deviation 0.0405 |
Other Pre-specified
Baseline Values of Systemic Biomarkers of Hematologic Function (Hemoglobin)
These will be assessed by blood samples taken at randomization visit in a subgroup of participants consented to contribute samples.
Time frame: Week 0
Population: Biomarker subset of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Hematologic Function (Hemoglobin) | 137 g/L | Standard Deviation 11.8 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Hematologic Function (Hemoglobin) | 141 g/L | Standard Deviation 8.8 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Hematologic Function (Hemoglobin) | 142 g/L | Standard Deviation 13.7 |
Other Pre-specified
Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Calprotectin, C-reactive Protein)
These will be assessed by blood samples taken at randomization visits of the study in a subgroup of participants consented to contribute samples.
Time frame: Week 0
Population: Biomarker subset of participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Calprotectin, C-reactive Protein) | Baseline Calprotectin (µg/mL) | 1.335 µg/mL | Standard Deviation 2.1836 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Calprotectin, C-reactive Protein) | Baseline C-reactive protein (µg/mL) | 6.253 µg/mL | Standard Deviation 5.9201 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Calprotectin, C-reactive Protein) | Baseline Calprotectin (µg/mL) | 1.091 µg/mL | Standard Deviation 1.8067 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Calprotectin, C-reactive Protein) | Baseline C-reactive protein (µg/mL) | 3.061 µg/mL | Standard Deviation 2.6015 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Calprotectin, C-reactive Protein) | Baseline Calprotectin (µg/mL) | 1.282 µg/mL | Standard Deviation 2.1241 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Calprotectin, C-reactive Protein) | Baseline C-reactive protein (µg/mL) | 4.391 µg/mL | Standard Deviation 8.5794 |
Other Pre-specified
Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL)
These will be assessed by blood samples taken at randomization visits of the study in a subgroup of participants consented to contribute samples.
Time frame: Week 0
Population: Biomarker subset of participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interleukin-1-beta (pg/mL) | 0.347 pg/mL | Standard Deviation 0.4324 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interleukin-6 (pg/mL) | 1.880 pg/mL | Standard Deviation 1.5469 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interleukin-8 (pg/mL) | 7.984 pg/mL | Standard Deviation 5.4974 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interleukin-10 (pg/mL) | 0.470 pg/mL | Standard Deviation 0.579 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interferon-lambda-1 (pg/mL) | 4.800 pg/mL | Standard Deviation 5.0653 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interferon-lambda-3 (pg/mL) | 43.006 pg/mL | Standard Deviation 15.0238 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interferon-gamma (pg/mL) | 25.235 pg/mL | Standard Deviation 68.946 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Tumor Necrosis Factor alpha (pg/mL) | 1.593 pg/mL | Standard Deviation 1.4729 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Cluster of Differentiation 40 ligand (pg/mL) | 1554.382 pg/mL | Standard Deviation 1450.9193 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interferon gamma-induced protein 10 (pg/mL) | 394.642 pg/mL | Standard Deviation 510.0155 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Cluster of Differentiation 40 ligand (pg/mL) | 1570.212 pg/mL | Standard Deviation 872.6533 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interleukin-1-beta (pg/mL) | 0.439 pg/mL | Standard Deviation 0.6867 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interferon-lambda-3 (pg/mL) | 15.015 pg/mL | Standard Deviation 2.6113 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interferon-lambda-1 (pg/mL) | 2.886 pg/mL | Standard Deviation 1.9873 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interleukin-6 (pg/mL) | 1.316 pg/mL | Standard Deviation 0.7612 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interferon gamma-induced protein 10 (pg/mL) | 331.127 pg/mL | Standard Deviation 247.5556 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Tumor Necrosis Factor alpha (pg/mL) | 1.093 pg/mL | Standard Deviation 0.6115 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interleukin-8 (pg/mL) | 7.174 pg/mL | Standard Deviation 4.1427 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interferon-gamma (pg/mL) | 10.449 pg/mL | Standard Deviation 12.3146 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interleukin-10 (pg/mL) | 0.308 pg/mL | Standard Deviation 0.1848 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Tumor Necrosis Factor alpha (pg/mL) | 1.210 pg/mL | Standard Deviation 0.8951 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interleukin-10 (pg/mL) | 0.282 pg/mL | Standard Deviation 0.1825 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interferon-lambda-1 (pg/mL) | 3.837 pg/mL | Standard Deviation 2.7632 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interferon-lambda-3 (pg/mL) | 16.589 pg/mL | Standard Deviation 0.3848 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Cluster of Differentiation 40 ligand (pg/mL) | 2201.813 pg/mL | Standard Deviation 1421.8699 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interferon-gamma (pg/mL) | 10772 pg/mL | Standard Deviation 10.489 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interleukin-1-beta (pg/mL) | 0.197 pg/mL | Standard Deviation 0.1472 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interferon gamma-induced protein 10 (pg/mL) | 257.239 pg/mL | Standard Deviation 160.3321 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interleukin-6 (pg/mL) | 1.424 pg/mL | Standard Deviation 0.8999 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Parameters in pg/mL) | Baseline Interleukin-8 (pg/mL) | 7.619 pg/mL | Standard Deviation 4.1476 |
Other Pre-specified
Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Serotonin, Tryptophan and Taurine)
These will be assessed by blood samples taken at randomization visits of the study in a subgroup of participants consented to contribute samples.
Time frame: Week 0
Population: Biomarker subset of participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Serotonin, Tryptophan and Taurine) | Baseline Tryptophan (µmol/L) | 56.688 µmol/L | Standard Deviation 11.3971 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Serotonin, Tryptophan and Taurine) | Baseline Serotonin (µmol/L) | 1.894 µmol/L | Standard Deviation 2.3104 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Serotonin, Tryptophan and Taurine) | Baseline Taurine (µmol/L) | 97.381 µmol/L | Standard Deviation 30.2629 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Serotonin, Tryptophan and Taurine) | Baseline Tryptophan (µmol/L) | 58.115 µmol/L | Standard Deviation 11.308 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Serotonin, Tryptophan and Taurine) | Baseline Serotonin (µmol/L) | 1.382 µmol/L | Standard Deviation 2.4128 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Serotonin, Tryptophan and Taurine) | Baseline Taurine (µmol/L) | 104.615 µmol/L | Standard Deviation 32.5454 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Serotonin, Tryptophan and Taurine) | Baseline Serotonin (µmol/L) | 1.915 µmol/L | Standard Deviation 1.9254 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Serotonin, Tryptophan and Taurine) | Baseline Taurine (µmol/L) | 108.351 µmol/L | Standard Deviation 39.1587 |
| Placebo for 3 Cycles (Arm 3, PPP) | Baseline Values of Systemic Biomarkers of Inflammation and Immunologic Function (Serotonin, Tryptophan and Taurine) | Baseline Tryptophan (µmol/L) | 55.397 µmol/L | Standard Deviation 8.5476 |
Other Pre-specified
Biomarkers of Pharmacodynamic Activity - Plasma Retinol
These will be assessed by blood samples taken at specific visits of the study in a subgroup of participants consented to contribute samples.
Time frame: Weeks 0, 2 and 10
Population: Biomarker subset of participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Biomarkers of Pharmacodynamic Activity - Plasma Retinol | Week 2 Retinol (µmol/L) | 0.42 µmol/L | Standard Deviation 0.198 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Biomarkers of Pharmacodynamic Activity - Plasma Retinol | Baseline Retinol (µmol/L) | 1.89 µmol/L | Standard Deviation 0.389 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Biomarkers of Pharmacodynamic Activity - Plasma Retinol | Week 10 Retinol (µmol/L) | 0.37 µmol/L | Standard Deviation 0.097 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Biomarkers of Pharmacodynamic Activity - Plasma Retinol | Week 2 Retinol (µmol/L) | 0.39 µmol/L | Standard Deviation 0.092 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Biomarkers of Pharmacodynamic Activity - Plasma Retinol | Baseline Retinol (µmol/L) | 1.92 µmol/L | Standard Deviation 0.303 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Biomarkers of Pharmacodynamic Activity - Plasma Retinol | Week 10 Retinol (µmol/L) | 2.08 µmol/L | Standard Deviation 0.541 |
| Placebo for 3 Cycles (Arm 3, PPP) | Biomarkers of Pharmacodynamic Activity - Plasma Retinol | Baseline Retinol (µmol/L) | 2.05 µmol/L | Standard Deviation 0.298 |
| Placebo for 3 Cycles (Arm 3, PPP) | Biomarkers of Pharmacodynamic Activity - Plasma Retinol | Week 10 Retinol (µmol/L) | 2.07 µmol/L | Standard Deviation 0.54 |
| Placebo for 3 Cycles (Arm 3, PPP) | Biomarkers of Pharmacodynamic Activity - Plasma Retinol | Week 2 Retinol (µmol/L) | 1.81 µmol/L | Standard Deviation 0.336 |
Other Pre-specified
Biomarkers of Pharmacodynamic Activity - Systematic Inflammation Index (SII)
These will be assessed by blood samples taken at specific visits of the study in a subgroup of participants consented to contribute samples. SII = (N × P)/L, where N, P and L (cells\*10\^9/L) represent absolute neutrophil counts, platelet counts and lymphocyte counts. Since SII is a ratio of concentrations, it is unitless.
Time frame: Weeks 0, 2 and 10
Population: Biomarker subset of participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Biomarkers of Pharmacodynamic Activity - Systematic Inflammation Index (SII) | Week 10 Systematic Inflammation Index | 639.5 unitless value | Standard Deviation 414.09 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Biomarkers of Pharmacodynamic Activity - Systematic Inflammation Index (SII) | Baseline Systematic Inflammation Index | 726.4 unitless value | Standard Deviation 358.63 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Biomarkers of Pharmacodynamic Activity - Systematic Inflammation Index (SII) | Week 2 Systematic Inflammation Index | 626.5 unitless value | Standard Deviation 370.06 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Biomarkers of Pharmacodynamic Activity - Systematic Inflammation Index (SII) | Week 10 Systematic Inflammation Index | 513.2 unitless value | Standard Deviation 159.02 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Biomarkers of Pharmacodynamic Activity - Systematic Inflammation Index (SII) | Baseline Systematic Inflammation Index | 545.2 unitless value | Standard Deviation 190.27 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Biomarkers of Pharmacodynamic Activity - Systematic Inflammation Index (SII) | Week 2 Systematic Inflammation Index | 558.9 unitless value | Standard Deviation 169.71 |
| Placebo for 3 Cycles (Arm 3, PPP) | Biomarkers of Pharmacodynamic Activity - Systematic Inflammation Index (SII) | Week 10 Systematic Inflammation Index | 563.5 unitless value | Standard Deviation 336.95 |
| Placebo for 3 Cycles (Arm 3, PPP) | Biomarkers of Pharmacodynamic Activity - Systematic Inflammation Index (SII) | Week 2 Systematic Inflammation Index | 632.2 unitless value | Standard Deviation 338.37 |
| Placebo for 3 Cycles (Arm 3, PPP) | Biomarkers of Pharmacodynamic Activity - Systematic Inflammation Index (SII) | Baseline Systematic Inflammation Index | 628.8 unitless value | Standard Deviation 322.79 |
Other Pre-specified
Changes Relative to Baseline (Percent Change) of Biomarker of Pharmacodynamic Activity - Retinol
These will be assessed by blood samples taken at specific visits of the study in a subgroup of participants consented to contribute samples.
Time frame: Weeks 0, 2 and 10
Population: Biomarker subset of participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Biomarker of Pharmacodynamic Activity - Retinol | Retinol % change from baseline at Week 2 | -78.9 percentage of baseline | Standard Deviation 5.94 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Biomarker of Pharmacodynamic Activity - Retinol | Retinol % change from baseline at Week 10 | -80.8 percentage of baseline | Standard Deviation 4.274 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Biomarker of Pharmacodynamic Activity - Retinol | Retinol % change from baseline at Week 2 | -79.5 percentage of baseline | Standard Deviation 6.36 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Biomarker of Pharmacodynamic Activity - Retinol | Retinol % change from baseline at Week 10 | 0.3 percentage of baseline | Standard Deviation 12.19 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Biomarker of Pharmacodynamic Activity - Retinol | Retinol % change from baseline at Week 2 | -4.4 percentage of baseline | Standard Deviation 8.24 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Biomarker of Pharmacodynamic Activity - Retinol | Retinol % change from baseline at Week 10 | 6.2 percentage of baseline | Standard Deviation 21.15 |
Other Pre-specified
Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function
These will be assessed by blood samples taken at specific visits of the study in a subgroup of participants consented to contribute samples.
Time frame: Weeks 0, 2 and 10
Population: Biomarker subset of participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Erythrocyte % change from baseline at Week 2 | -1.29 Percentage of change | Standard Deviation 3.267 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Erythrocyte % change from baseline at Week 10 | -0.55 Percentage of change | Standard Deviation 7.443 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Leucocyte % change from baseline at Week 2 | -2.89 Percentage of change | Standard Deviation 18.551 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Leucocyte % change from baseline at Week 10 | 5.70 Percentage of change | Standard Deviation 37.957 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Platelet % change from baseline at Week 2 | -2.90 Percentage of change | Standard Deviation 10.746 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Platelet % change from baseline at Week 10 | -3.14 Percentage of change | Standard Deviation 12.807 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Hematocrit % change at Week 2 | -1.66 Percentage of change | Standard Deviation 4.349 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Hematocrit % change at Week 10 | -1.08 Percentage of change | Standard Deviation 3.956 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Hemoglobin % change at Week 2 | -1.37 Percentage of change | Standard Deviation 3.329 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Hemoglobin % change at Week 10 | -0.74 Percentage of change | Standard Deviation 4.194 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Neutrophil % change at Week 2 | -6.02 Percentage of change | Standard Deviation 24.371 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Neutrophil % change at Week 10 | 5.62 Percentage of change | Standard Deviation 52.222 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Neutrophil % change at Week 10 | 6.71 Percentage of change | Standard Deviation 25.699 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Erythrocyte % change from baseline at Week 2 | -0.98 Percentage of change | Standard Deviation 4.386 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Hematocrit % change at Week 2 | -1.18 Percentage of change | Standard Deviation 3.988 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Hemoglobin % change at Week 2 | -0.83 Percentage of change | Standard Deviation 3.194 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Erythrocyte % change from baseline at Week 10 | -0.44 Percentage of change | Standard Deviation 4.418 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Platelet % change from baseline at Week 10 | -2.25 Percentage of change | Standard Deviation 12.003 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Neutrophil % change at Week 2 | 10.47 Percentage of change | — |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Leucocyte % change from baseline at Week 2 | 4.90 Percentage of change | Standard Deviation 21.194 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Hematocrit % change at Week 10 | -0.41 Percentage of change | Standard Deviation 4.632 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Platelet % change from baseline at Week 2 | -3.39 Percentage of change | Standard Deviation 15.811 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Leucocyte % change from baseline at Week 10 | 5.31 Percentage of change | Standard Deviation 14.887 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Hemoglobin % change at Week 10 | -0.71 Percentage of change | Standard Deviation 3.712 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Leucocyte % change from baseline at Week 10 | -2.97 Percentage of change | Standard Deviation 15.053 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Platelet % change from baseline at Week 2 | 2.66 Percentage of change | Standard Deviation 9.501 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Hemoglobin % change at Week 10 | -1.70 Percentage of change | Standard Deviation 3.91 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Platelet % change from baseline at Week 10 | 0.45 Percentage of change | Standard Deviation 12.018 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Hematocrit % change at Week 2 | 0.26 Percentage of change | Standard Deviation 3.96 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Hematocrit % change at Week 10 | -1.28 Percentage of change | Standard Deviation 5.252 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Neutrophil % change at Week 2 | -0.22 Percentage of change | Standard Deviation 27.398 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Erythrocyte % change from baseline at Week 2 | 0.34 Percentage of change | Standard Deviation 3.482 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Erythrocyte % change from baseline at Week 10 | -1.40 Percentage of change | Standard Deviation 4.534 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Hemoglobin % change at Week 2 | -0.51 Percentage of change | Standard Deviation 3.439 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Leucocyte % change from baseline at Week 2 | 0.05 Percentage of change | Standard Deviation 19.758 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Hematologic Function | Neutrophil % change at Week 10 | -6.75 Percentage of change | Standard Deviation 22.195 |
Other Pre-specified
Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function
These will be assessed by blood samples taken at specific visits of the study in a subgroup of participants consented to contribute samples.
Time frame: Weeks 0, 2 and 10
Population: Biomarker subset of participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Tumor Necrosis Factor alpha % change at Week 10 | 76.3 Percentage of change | Standard Deviation 206.1 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Calprotectin % change at Week 10 | 9.6 Percentage of change | Standard Deviation 78.6 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-6 % change from baseline at Week 2 | 33.6 Percentage of change | Standard Deviation 138.1 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | C-reactive protein % change at Week 2 | 25.2 Percentage of change | Standard Deviation 95.4 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-10 % change at Week 10 | 39.3 Percentage of change | Standard Deviation 125.1 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | C-reactive protein % change at Week 10 | -8.9 Percentage of change | Standard Deviation 46.1 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Serotonin % change at Week 2 | 10.5 Percentage of change | Standard Deviation 50.7 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Serotonin % change at Week 10 | 51.2 Percentage of change | Standard Deviation 98.9 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon-lambda-1 % change at Week 2 | 1.1 Percentage of change | Standard Deviation 46.2 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Tryptophan % change at Week 2 | -1.2 Percentage of change | Standard Deviation 24.8 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Tryptophan % change at Week 10 | 8.1 Percentage of change | Standard Deviation 31.1 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Taurine % change at Week 2 | 13.1 Percentage of change | Standard Deviation 38.5 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-1-beta % change from baseline at Week 2 | 71.6 Percentage of change | Standard Deviation 245.5 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Taurine % change at Week 10 | 12.4 Percentage of change | Standard Deviation 36.2 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon-lambda-1 % change at Week 10 | 127.0 Percentage of change | Standard Deviation 152 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-6 % change from baseline at Week 10 | 38.3 Percentage of change | Standard Deviation 182.9 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon-lambda-3 % change at Week 2 | -10.5 Percentage of change | Standard Deviation 10.8 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon-lambda-3 % change at Week 10 | -16.9 Percentage of change | — |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon-gamma % change at Week 2 | 43.7 Percentage of change | Standard Deviation 146.8 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-1-beta % change from baseline at Week 10 | 32.1 Percentage of change | Standard Deviation 151.1 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon-gamma % change at Week 10 | -16.1 Percentage of change | Standard Deviation 50 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-8 % change from baseline at Week 2 | 14.9 Percentage of change | Standard Deviation 48.3 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Tumor Necrosis Factor alpha % change at Week 2 | 112.3 Percentage of change | Standard Deviation 459.7 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Calprotectin % change at Week 2 | 187.7 Percentage of change | Standard Deviation 658.7 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Cluster of Differentiation 40 ligand % change at Week 2 | 43.6 Percentage of change | Standard Deviation 106.3 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-8 % change from baseline at Week 10 | 35.6 Percentage of change | Standard Deviation 59.4 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Cluster of Differentiation 40 ligand % change at Week 10 | 36.1 Percentage of change | Standard Deviation 100 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon gamma-induced protein 10 % change at Week 2 | 18.0 Percentage of change | Standard Deviation 68.6 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon gamma-induced protein 10 % change at Week 10 | -29.5 Percentage of change | Standard Deviation 35.1 |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-10 % change at Week 2 | 43.6 Percentage of change | Standard Deviation 119.8 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-8 % change from baseline at Week 10 | 19.8 Percentage of change | Standard Deviation 58.6 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Calprotectin % change at Week 2 | 159.8 Percentage of change | Standard Deviation 572.9 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-10 % change at Week 2 | 43.4 Percentage of change | Standard Deviation 121.9 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Tumor Necrosis Factor alpha % change at Week 10 | 21.9 Percentage of change | Standard Deviation 72.2 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Calprotectin % change at Week 10 | 193.2 Percentage of change | Standard Deviation 629.7 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon-lambda-3 % change at Week 2 | 10.4 Percentage of change | Standard Deviation 46 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-6 % change from baseline at Week 10 | -10.6 Percentage of change | Standard Deviation 30.8 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | C-reactive protein % change at Week 2 | 185.6 Percentage of change | Standard Deviation 549.4 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-1-beta % change from baseline at Week 10 | -23.6 Percentage of change | Standard Deviation 32.3 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon-lambda-3 % change at Week 10 | 87.1 Percentage of change | Standard Deviation 10.9 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | C-reactive protein % change at Week 10 | 19.3 Percentage of change | Standard Deviation 55.2 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-10 % change at Week 10 | -14.2 Percentage of change | Standard Deviation 37.6 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon gamma-induced protein 10 % change at Week 10 | -32.0 Percentage of change | Standard Deviation 32.7 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Serotonin % change at Week 2 | 274.5 Percentage of change | Standard Deviation 1257.3 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-6 % change from baseline at Week 2 | 30.7 Percentage of change | Standard Deviation 77.3 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon-gamma % change at Week 2 | 134.3 Percentage of change | Standard Deviation 320.8 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Serotonin % change at Week 10 | 9.0 Percentage of change | Standard Deviation 65.3 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Cluster of Differentiation 40 ligand % change at Week 2 | 35.7 Percentage of change | Standard Deviation 106.1 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon gamma-induced protein 10 % change at Week 2 | 37.0 Percentage of change | Standard Deviation 64.1 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Tryptophan % change at Week 2 | 2.4 Percentage of change | Standard Deviation 15.3 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon-lambda-1 % change at Week 2 | 19.4 Percentage of change | Standard Deviation 77.6 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon-gamma % change at Week 10 | -32.8 Percentage of change | Standard Deviation 40.8 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Tryptophan % change at Week 10 | 2.7 Percentage of change | Standard Deviation 16 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-1-beta % change from baseline at Week 2 | 45.9 Percentage of change | Standard Deviation 207 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Taurine % change at Week 2 | 13.0 Percentage of change | Standard Deviation 47.1 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Cluster of Differentiation 40 ligand % change at Week 10 | 36.7 Percentage of change | Standard Deviation 113.1 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Tumor Necrosis Factor alpha % change at Week 2 | 65.1 Percentage of change | Standard Deviation 147.5 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Taurine % change at Week 10 | 5.6 Percentage of change | Standard Deviation 38.9 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-8 % change from baseline at Week 2 | 12.9 Percentage of change | Standard Deviation 29.1 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon-lambda-1 % change at Week 10 | 90.9 Percentage of change | Standard Deviation 113.6 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Taurine % change at Week 10 | 18.0 Percentage of change | Standard Deviation 50.7 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-1-beta % change from baseline at Week 2 | 19.3 Percentage of change | Standard Deviation 55.3 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-1-beta % change from baseline at Week 10 | 176.5 Percentage of change | Standard Deviation 678.5 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-6 % change from baseline at Week 2 | 19.6 Percentage of change | Standard Deviation 50.6 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-6 % change from baseline at Week 10 | 35.7 Percentage of change | Standard Deviation 165.6 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-8 % change from baseline at Week 2 | 27.2 Percentage of change | Standard Deviation 127.7 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-8 % change from baseline at Week 10 | 15.6 Percentage of change | Standard Deviation 51.3 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-10 % change at Week 2 | 8.2 Percentage of change | Standard Deviation 31 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interleukin-10 % change at Week 10 | 52.6 Percentage of change | Standard Deviation 283.2 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon-lambda-1 % change at Week 2 | 8.3 Percentage of change | Standard Deviation 51 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon-lambda-1 % change at Week 10 | 92.7 Percentage of change | Standard Deviation 245.1 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon-lambda-3 % change at Week 2 | -4.15 Percentage of change | — |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon-gamma % change at Week 2 | 115.4 Percentage of change | Standard Deviation 513.3 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon-gamma % change at Week 10 | 5.4 Percentage of change | Standard Deviation 86.8 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Tumor Necrosis Factor alpha % change at Week 2 | 17.0 Percentage of change | Standard Deviation 59.7 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Tumor Necrosis Factor alpha % change at Week 10 | 84.9 Percentage of change | Standard Deviation 187.2 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Cluster of Differentiation 40 ligand % change at Week 2 | 60.3 Percentage of change | Standard Deviation 188.2 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Cluster of Differentiation 40 ligand % change at Week 10 | 43.2 Percentage of change | Standard Deviation 108.8 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon gamma-induced protein 10 % change at Week 2 | 15.9 Percentage of change | Standard Deviation 45.6 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Interferon gamma-induced protein 10 % change at Week 10 | -10.5 Percentage of change | Standard Deviation 54.3 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Calprotectin % change at Week 2 | 65.3 Percentage of change | Standard Deviation 256 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Calprotectin % change at Week 10 | 219.1 Percentage of change | Standard Deviation 615.5 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | C-reactive protein % change at Week 2 | 3.5 Percentage of change | Standard Deviation 25.7 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | C-reactive protein % change at Week 10 | 71.6 Percentage of change | Standard Deviation 236.3 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Serotonin % change at Week 2 | 606.1 Percentage of change | Standard Deviation 2059.9 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Serotonin % change at Week 10 | 5.1 Percentage of change | Standard Deviation 96.2 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Tryptophan % change at Week 2 | 4.4 Percentage of change | Standard Deviation 21.4 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Taurine % change at Week 2 | 29.7 Percentage of change | Standard Deviation 77 |
| Placebo for 3 Cycles (Arm 3, PPP) | Changes Relative to Baseline (Percent Change) of Systemic Biomarkers of Inflammation and Immunologic Function | Tryptophan % change at Week 10 | 1.2 Percentage of change | Standard Deviation 18.5 |
Other Pre-specified
Health and Survival Follow-up (Week 24), Long COVID Symptom Count
This is now presented as part of Outcome #17. Initially planned to be separate from the reporting and analysis of the Week 12 outcomes, a longer term contact was made at Week 24 to assess the following: Presence or not of Long COVID symptoms (total number of Long COVID symptoms).
Time frame: Week 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Health and Survival Follow-up (Week 24), Long COVID Symptom Count | 14.4 counts of symptoms | Standard Deviation 7.26 |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Health and Survival Follow-up (Week 24), Long COVID Symptom Count | 14.8 counts of symptoms | Standard Deviation 8.2 |
| Placebo for 3 Cycles (Arm 3, PPP) | Health and Survival Follow-up (Week 24), Long COVID Symptom Count | 14.7 counts of symptoms | Standard Deviation 7.65 |
Other Pre-specified
Health and Survival Follow-up (Week 24), Significant Cardiovascular Events
General health check-up: Assess significant cardiovascular events (one that results in at least an acute care visit, a hospitalization or an event-related death) and survival.
Time frame: Week 24
Population: ITT population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | Health and Survival Follow-up (Week 24), Significant Cardiovascular Events | Participants with significant cardiovascular events or death through Week 24 | 0 Participants |
| LAU-7b for 3 Cycles (Arm 1, AAA) | Health and Survival Follow-up (Week 24), Significant Cardiovascular Events | Participants without significant cardiovascular events or death through Week 24 | 91 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Health and Survival Follow-up (Week 24), Significant Cardiovascular Events | Participants with significant cardiovascular events or death through Week 24 | 0 Participants |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Health and Survival Follow-up (Week 24), Significant Cardiovascular Events | Participants without significant cardiovascular events or death through Week 24 | 91 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Health and Survival Follow-up (Week 24), Significant Cardiovascular Events | Participants with significant cardiovascular events or death through Week 24 | 0 Participants |
| Placebo for 3 Cycles (Arm 3, PPP) | Health and Survival Follow-up (Week 24), Significant Cardiovascular Events | Participants without significant cardiovascular events or death through Week 24 | 90 Participants |