A Phase 2/3 interventional study of LAU-7b for 3 cycles and LAU-7b for 1 cycle, then placebo in Long COVID, sponsored by Laurent Pharmaceuticals Inc.. Completed at 5 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Laurent Pharmaceuticals Inc. · Phase 2/3, Interventional, and Treatment
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.
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.
604 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 201 are open to participants now.
This study's enrollment of 272 is above the median of 60 across 416 interventional studies indexed under Post-Acute COVID-19 Syndrome.
Browse Post-Acute COVID-19 Syndrome studies →Laurent Pharmaceuticals Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 for participation in the study. In case of doubt, the Investigator should consult with the Sponsor's medical representative:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.
Drug: LAU-7b for 3 cycles
Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.
Drug: LAU-7b for 1 cycle, then placebo
Each study arm will consist of three (3) cycles of 14 days of treatment intake each spaced by a treatment holiday of 14 days.
Other: Placebo for 3 cycles
Three cycles of 14 days of once-a-day intake of LAU-7b, each followed by a treatment intake pause of 14 days.
Also known as: fenretinide
One cycle of 14 days of once-a-day intake of LAU-7b followed by two cycles of 14 days of placebo administered similarly, each followed by a treatment intake pause of 14 days.
Also known as: fenretinide
Three cycles of 14 days of once-a-day intake of placebo, each followed by a treatment intake pause of 14 days
Also known as: sugar pill
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Started | 91 | 91 | 90 |
| Completed | 88 | 90 | 90 |
| Not completed | 3 | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 1 | 0 |
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.
| score on a scale | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| PCS at Week 12 | 29.47 ± 9.267 | 29.90 ± 7.941 | 30.06 ± 9.484 |
| Change from Baseline PCS | 1.94 ± 8.034 | 3.32 ± 7.777 | 2.78 ± 8.298 |
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.
| participants | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Participants with treatment-emergent adverse events | 71 | 71 | 61 |
| Participants with serious treatment-emergent adverse events | 1 | 2 | 2 |
| Participants with treatment-emergent adverse events leading to treatment discontinuation | 7 | 0 | 1 |
| Participants with treatment-emergent adverse events with fatal outcome | 0 | 0 | 0 |
| Participants with suspected unexpected serious adverse reaction (SUSAR) | 0 | 0 | 0 |
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.
| Participants | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| PGI-C at Week 4 — Very much improved | 0 | 1 | 1 |
| PGI-C at Week 4 — Much improved | 10 | 3 | 3 |
| PGI-C at Week 4 — Minimally improved | 25 | 25 | 25 |
| PGI-C at Week 4 — No change | 43 | 46 | 47 |
| PGI-C at Week 4 — Minimally worse | 6 | 7 | 6 |
| PGI-C at Week 4 — Much worse | 2 | 3 | 1 |
| PGI-C at Week 4 — Very much worse | 1 | 3 | 2 |
| PGI-C at Week 8 — Very much improved | 3 | 0 | 3 |
| PGI-C at Week 8 — Much improved | 11 | 5 | 1 |
| PGI-C at Week 8 — Minimally improved | 23 | 28 | 32 |
| PGI-C at Week 8 — No change | 39 | 42 | 35 |
| PGI-C at Week 8 — Minimally worse | 8 | 8 | 10 |
| PGI-C at Week 8 — Much worse | 2 | 6 | 3 |
| PGI-C at Week 8 — Very much worse | 1 | 0 | 1 |
| PGI-C at Week 12 — Very much improved | 7 | 0 | 2 |
| PGI-C at Week 12 — Much improved | 9 | 5 | 13 |
| PGI-C at Week 12 — Minimally improved | 18 | 37 | 30 |
| PGI-C at Week 12 — No change | 43 | 38 | 29 |
| PGI-C at Week 12 — Minimally worse | 8 | 5 | 11 |
| PGI-C at Week 12 — Much worse | 2 | 5 | 4 |
| PGI-C at Week 12 — Very much worse | 1 | 0 | 1 |
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.
| Participants | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Marked improvement of PGI-C at Week 4 — Participants achieving a marked improvement | 10 | 4 | 4 |
| Marked improvement of PGI-C at Week 4 — No marked improvement | 77 | 84 | 81 |
| Marked improvement of PGI-C at Week 8 — Participants achieving a marked improvement | 14 | 5 | 4 |
| Marked improvement of PGI-C at Week 8 — No marked improvement | 73 | 84 | 81 |
| Marked improvement of PGI-C at Week 12 — Participants achieving a marked improvement | 16 | 5 | 15 |
| Marked improvement of PGI-C at Week 12 — No marked improvement | 72 | 85 | 75 |
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.
| units on a scale | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Value at baseline | 15.68 ± 8.141 | 15.18 ± 6.940 | 16.48 ± 8.456 |
| Value at Week 4 | 20.28 ± 11.524 | 17.77 ± 9.499 | 19.33 ± 9.930 |
| Change from baseline at Week 4 | 4.70 ± 8.535 | 2.67 ± 7.005 | 2.91 ± 8.103 |
| Value at Week 8 | 21.67 ± 12.426 | 18.20 ± 9.309 | 19.60 ± 10.140 |
| Change from baseline at Week 8 | 5.94 ± 8.535 | 3.14 ± 8.099 | 3.29 ± 9.057 |
| Value at Week 12 | 20.63 ± 11.914 | 19.07 ± 9.547 | 22.19 ± 11.082 |
| Change from baseline at Week 12 | 5.07 ± 8.507 | 4.07 ± 7.998 | 5.73 ± 10.749 |
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.
| Participants | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Baseline — Participants with PEM | 81 | 87 | 84 |
| Baseline — Participants without PEM | 7 | 3 | 6 |
| Week 12 — Participants with PEM | 80 | 82 | 83 |
| Week 12 — Participants without PEM | 7 | 8 | 7 |
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.
| units on a scale | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| PCS at Week 4 | 28.71 ± 6.934 | 29.18 ± 8.350 | 28.20 ± 8.767 |
| Change from baseline PCS at Week 4 | 1.26 ± 6.950 | 2.89 ± 7.514 | 1.05 ± 7.661 |
| PCS at Week 8 | 30.35 ± 9.333 | 29.39 ± 8.295 | 29.64 ± 9.051 |
| Change from baseline PCS at Week 8 | 2.64 ± 8.806 | 2.81 ± 7.117 | 2.28 ± 7.897 |
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.
| units on a scale | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Baseline vitality score | 17.6 ± 14.36 | 14.8 ± 12.55 | 18.8 ± 14.61 |
| Change from baseline vitality score at Week 4 | 7.6 ± 16.64 | 7.2 ± 14.61 | 3.9 ± 15.38 |
| Change from baseline vitality score at Week 8 | 10.6 ± 18.25 | 5.8 ± 14.74 | 6.2 ± 18.54 |
| Change from baseline vitality score at Week 12 | 7.1 ± 17.78 | 6.9 ± 14.23 | 7.8 ± 19.64 |
| Baseline physical functioning score | 42.8 ± 22.85 | 38.1 ± 20.55 | 41.6 ± 23.68 |
| Change from baseline physical functioning score at Week 4 | -0.5 ± 21.19 | 5.8 ± 21.36 | -1.7 ± 22.09 |
| Change from baseline physical functioning score at Week 8 | 3.9 ± 24.65 | 4.8 ± 23.31 | 2.2 ± 25.05 |
| Change from baseline physical functioning score at Week 12 | 3.1 ± 26.71 | 8.0 ± 26.95 | 4.6 ± 25.69 |
| Baseline bodily pain score | 35.7 ± 24.45 | 37.5 ± 23.44 | 35.3 ± 22.04 |
| Change from baseline bodily pain score at Week 4 | 2.4 ± 20.50 | 0.4 ± 21.16 | 3.7 ± 15.09 |
| Change from baseline bodily pain score at Week 8 | 6.2 ± 19.87 | 3.0 ± 20.85 | 6.3 ± 17.94 |
| Change from baseline bodily pain score at Week 12 | 4.1 ± 18.92 | 4.2 ± 18.35 | 12.0 ± 24.68 |
| Baseline general health perception score | 30.0 ± 15.80 | 31.4 ± 14.96 | 31.8 ± 16.65 |
| Change from baseline general health perception score at Week 4 | 3.6 ± 11.85 | 2.0 ± 11.20 | 0.8 ± 12.45 |
| Change from baseline general health perception score at Week 8 | 5.1 ± 13.85 | 1.9 ± 11.66 | 1.2 ± 13.05 |
| Change from baseline general health perception score at Week 12 | 5.4 ± 14.57 | 3.4 ± 13.33 | 2.3 ± 14.61 |
| Baseline physical role functioning score | 1.7 ± 8.30 | 0.8 ± 4.54 | 3.7 ± 14.45 |
| Change from baseline physical role functioning score at Week 4 | 3.0 ± 17.20 | 4.5 ± 16.99 | 3.0 ± 23.37 |
| Change from baseline physical role functioning score at Week 8 | 7.5 ± 23.01 | 5.0 ± 18.82 | 6.4 ± 26.30 |
| Change from baseline physical role functioning score at Week 12 | 2.9 ± 17.00 | 2.3 ± 11.90 | 4.3 ± 20.95 |
| Baseline emotional role functioning | 47.0 ± 45.38 | 55.8 ± 46.00 | 51.5 ± 44.61 |
| Change from baseline emotional role functioning score at Week 4 | -2.4 ± 44.41 | -10.3 ± 45.40 | -5.3 ± 38.66 |
| Change from baseline emotional role functioning score at Week 8 | 6.4 ± 49.79 | -6.7 ± 46.80 | -0.4 ± 44.90 |
| Change from baseline emotional role functioning score at Week 12 | 1.6 ± 48.50 | -6.6 ± 43.93 | 6.9 ± 43.37 |
| Baseline social role functioning score | 23.9 ± 19.66 | 23.3 ± 19.06 | 26.6 ± 19.68 |
| Change from baseline social role functioning score at Week 4 | 5.6 ± 18.95 | 3.9 ± 17.56 | 4.4 ± 16.82 |
| Change from baseline social role functioning score at Week 8 | 10.4 ± 20.08 | 5.4 ± 18.94 | 7.2 ± 19.15 |
| Change from baseline social role functioning score at Week 12 | 10.4 ± 21.12 | 7.6 ± 20.15 | 9.3 ± 23.75 |
| Baseline mental health score | 55.7 ± 6.28 | 56.1 ± 8.11 | 56.2 ± 8.05 |
| Change from baseline mental health score at Week 4 | 1.0 ± 7.04 | -0.2 ± 7.62 | 1.3 ± 7.98 |
| Change from baseline mental health score at Week 8 | 0.7 ± 6.89 | -0.2 ± 7.40 | 0.7 ± 7.09 |
| Change from baseline mental health score at Week 12 | 1.0 ± 7.66 | -0.0 ± 8.45 | -0.1 ± 7.92 |
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."
| Participants | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Week 4 — Participants who judge to have regained daily usual activity level | 0 | 3 | 0 |
| Week 4 — Participants who judge NOT to have regained daily usual activity level | 89 | 88 | 90 |
| Week 8 — Participants who judge to have regained daily usual activity level | 0 | 0 | 1 |
| Week 8 — Participants who judge NOT to have regained daily usual activity level | 88 | 90 | 89 |
| Week 12 — Participants who judge to have regained daily usual activity level | 0 | 1 | 2 |
| Week 12 — Participants who judge NOT to have regained daily usual activity level | 88 | 89 | 88 |
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.
| Participants | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Week 4 — Participants with at least 25% improvement in burdensome symptoms total score | 10 | 6 | 6 |
| Week 4 — Participants not reaching 25% improvement in burdensome symptoms total score | 79 | 84 | 84 |
| Week 8 — Participants with at least 25% improvement in burdensome symptoms total score | 15 | 18 | 7 |
| Week 8 — Participants not reaching 25% improvement in burdensome symptoms total score | 68 | 72 | 81 |
| Week 12 — Participants with at least 25% improvement in burdensome symptoms total score | 15 | 16 | 18 |
| Week 12 — Participants not reaching 25% improvement in burdensome symptoms total score | 70 | 73 | 70 |
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.
| Participants | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Week 4 — Participants with at least 50% improvement in burdensome symptoms total score | 6 | 1 | 2 |
| Week 4 — Participants not reaching 50% improvement in burdensome symptoms total score | 83 | 89 | 88 |
| Week 8 — Participants with at least 50% improvement in burdensome symptoms total score | 9 | 3 | 4 |
| Week 8 — Participants not reaching 50% improvement in burdensome symptoms total score | 74 | 87 | 84 |
| Week 12 — Participants with at least 50% improvement in burdensome symptoms total score | 7 | 3 | 10 |
| Week 12 — Participants not reaching 50% improvement in burdensome symptoms total score | 78 | 86 | 78 |
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.
| Participants | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Week 4 — Participants with at least 75% improvement in burdensome symptoms total score | 2 | 0 | 0 |
| Week 4 — Participants not reaching 75% improvement in burdensome symptoms total score | 87 | 90 | 90 |
| Week 8 — Participants with at least 75% improvement in burdensome symptoms total score | 1 | 0 | 1 |
| Week 8 — Participants not reaching 75% improvement in burdensome symptoms total score | 82 | 90 | 87 |
| Week 12 — Participants with at least 75% improvement in burdensome symptoms total score | 1 | 0 | 1 |
| Week 12 — Participants not reaching 75% improvement in burdensome symptoms total score | 84 | 89 | 87 |
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.
| score on a scale | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Baseline Summary Index | 0.60 ± 0.195 | 0.56 ± 0.209 | 0.58 ± 0.213 |
| Change from baseline at Week 4 | 0.01 ± 0.178 | 0.03 ± 0.164 | 0.04 ± 0.150 |
| Change from baseline at Week 8 | 0.03 ± 0.158 | 0.02 ± 0.188 | 0.03 ± 0.174 |
| Change from baseline at Week 12 | 0.04 ± 0.150 | 0.03 ± 0.168 | 0.08 ± 0.187 |
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)
| Participants | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Participants with relief of at least one core burdensome symptom | 8 | 9 | 9 |
| Participants without relief of core burdensome symptoms | 83 | 82 | 81 |
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.
| days | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | 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. | 60.13 ± 19.23 | 64.78 ± 19.38 | 71.67 ± 14.64 |
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.
| Participants | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Week 4 — Participants achieving sustained recovery of all core symptoms | 0 | 0 | 0 |
| Week 4 — Participants NOT achieving sustained recovery of all core symptoms | 89 | 91 | 90 |
| Week 8 — Participants achieving sustained recovery of all core symptoms | 0 | 0 | 0 |
| Week 8 — Participants NOT achieving sustained recovery of all core symptoms | 88 | 90 | 90 |
| Week 12 — Participants achieving sustained recovery of all core symptoms | 0 | 0 | 0 |
| Week 12 — Participants NOT achieving sustained recovery of all core symptoms | 88 | 90 | 90 |
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.
| count of symptoms | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Baseline count of all Long COVID symptoms | 14.3 ± 7.07 | 15.2 ± 7.98 | 15.0 ± 7.88 |
| Count of all Long COVID symptoms at Week 4 | 14.2 ± 7.06 | 15.1 ± 8.04 | 15.0 ± 7.90 |
| Count of all Long COVID symptoms at Week 8 | 14.4 ± 7.25 | 15.0 ± 8.07 | 14.9 ± 7.57 |
| Count of all Long COVID symptoms at Week 12 | 14.4 ± 7.18 | 15.0 ± 8.05 | 14.9 ± 7.55 |
| Count of all Long COVID symptoms at Week 24 | 14.4 ± 7.26 | 14.8 ± 8.20 | 14.7 ± 7.65 |
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
| Participants | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Participants with Long COVID-related unplanned medical visits | 2 | 3 | 5 |
| Participants without Long COVID-related unplanned medical visits | 89 | 88 | 85 |
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
| Participants | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Participants deceased from any cause through Week 12 | 0 | 0 | 0 |
| Participants alive through Week 12 | 91 | 91 | 90 |
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
| Participants | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Participants with significant cardiovascular event through Week 24 | 0 | 0 | 0 |
| Participants without significant cardiovascular event through Week 24 | 91 | 91 | 90 |
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).
| counts of symptoms | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Health and Survival Follow-up (Week 24), Long COVID Symptom Count | 14.4 ± 7.26 | 14.8 ± 8.20 | 14.7 ± 7.65 |
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.
| Participants | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Participants with significant cardiovascular events or death through Week 24 | 0 | 0 | 0 |
| Participants without significant cardiovascular events or death through Week 24 | 91 | 91 | 90 |
These will be assessed by blood samples taken at randomization visit in a subgroup of participants consented to contribute samples.
| cells*10^9/L | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Erythrocyte count (10^9/L) - Baseline | 4496 ± 442.2 | 4703 ± 384.7 | 4610 ± 431.8 |
| Leucocyte count (10^9/L) - Baseline | 6.53 ± 2.102 | 5.99 ± 1.576 | 6.28 ± 1.634 |
| Platelet count (10^9/L) - Baseline | 265 ± 75.9 | 261 ± 56.8 | 252 ± 73.1 |
| Neutrophil count (10^9/L) - Baseline | 4.23 ± 1.655 | 3.59 ± 1.307 | 3.95 ± 1.369 |
These will be assessed by blood samples taken at randomization visit in a subgroup of participants consented to contribute samples.
| g/L | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Baseline Values of Systemic Biomarkers of Hematologic Function (Hemoglobin) | 137 ± 11.8 | 141 ± 8.8 | 142 ± 13.7 |
These will be assessed by blood samples taken at randomization visit in a subgroup of participants consented to contribute samples.
| L/L | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Baseline Values of Systemic Biomarkers of Hematologic Function (Hematocrit) | 0.409 ± 0.0358 | 0.417 ± 0.0269 | 0.418 ± 0.0405 |
These will be assessed by blood samples taken at specific visits of the study in a subgroup of participants consented to contribute samples.
| Percentage of change | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Erythrocyte % change from baseline at Week 2 | -1.29 ± 3.267 | -0.98 ± 4.386 | 0.34 ± 3.482 |
| Erythrocyte % change from baseline at Week 10 | -0.55 ± 7.443 | -0.44 ± 4.418 | -1.40 ± 4.534 |
| Leucocyte % change from baseline at Week 2 | -2.89 ± 18.551 | 4.90 ± 21.194 | 0.05 ± 19.758 |
| Leucocyte % change from baseline at Week 10 | 5.70 ± 37.957 | 5.31 ± 14.887 | -2.97 ± 15.053 |
| Platelet % change from baseline at Week 2 | -2.90 ± 10.746 | -3.39 ± 15.811 | 2.66 ± 9.501 |
| Platelet % change from baseline at Week 10 | -3.14 ± 12.807 | -2.25 ± 12.003 | 0.45 ± 12.018 |
| Hematocrit % change at Week 2 | -1.66 ± 4.349 | -1.18 ± 3.988 | 0.26 ± 3.960 |
| Hematocrit % change at Week 10 | -1.08 ± 3.956 | -0.41 ± 4.632 | -1.28 ± 5.252 |
| Hemoglobin % change at Week 2 | -1.37 ± 3.329 | -0.83 ± 3.194 | -0.51 ± 3.439 |
| Hemoglobin % change at Week 10 | -0.74 ± 4.194 | -0.71 ± 3.712 | -1.70 ± 3.910 |
| Neutrophil % change at Week 2 | -6.02 ± 24.371 | 10.47 ± 34,679 | -0.22 ± 27.398 |
| Neutrophil % change at Week 10 | 5.62 ± 52.222 | 6.71 ± 25.699 | -6.75 ± 22.195 |
These will be assessed by blood samples taken at randomization visits of the study in a subgroup of participants consented to contribute samples.
| pg/mL | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Baseline Interleukin-1-beta (pg/mL) | 0.347 ± 0.4324 | 0.439 ± 0.6867 | 0.197 ± 0.1472 |
| Baseline Interleukin-6 (pg/mL) | 1.880 ± 1.5469 | 1.316 ± 0.7612 | 1.424 ± 0.8999 |
| Baseline Interleukin-8 (pg/mL) | 7.984 ± 5.4974 | 7.174 ± 4.1427 | 7.619 ± 4.1476 |
| Baseline Interleukin-10 (pg/mL) | 0.470 ± 0.5790 | 0.308 ± 0.1848 | 0.282 ± 0.1825 |
| Baseline Interferon-lambda-1 (pg/mL) | 4.800 ± 5.0653 | 2.886 ± 1.9873 | 3.837 ± 2.7632 |
| Baseline Interferon-lambda-3 (pg/mL) | 43.006 ± 15.0238 | 15.015 ± 2.6113 | 16.589 ± 0.3848 |
| Baseline Interferon-gamma (pg/mL) | 25.235 ± 68.9460 | 10.449 ± 12.3146 | 10772 ± 10.4890 |
| Baseline Tumor Necrosis Factor alpha (pg/mL) | 1.593 ± 1.4729 | 1.093 ± 0.6115 | 1.210 ± 0.8951 |
| Baseline Cluster of Differentiation 40 ligand (pg/mL) | 1554.382 ± 1450.9193 | 1570.212 ± 872.6533 | 2201.813 ± 1421.8699 |
| Baseline Interferon gamma-induced protein 10 (pg/mL) | 394.642 ± 510.0155 | 331.127 ± 247.5556 | 257.239 ± 160.3321 |
These will be assessed by blood samples taken at randomization visits of the study in a subgroup of participants consented to contribute samples.
| µg/mL | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Baseline Calprotectin (µg/mL) | 1.335 ± 2.1836 | 1.091 ± 1.8067 | 1.282 ± 2.1241 |
| Baseline C-reactive protein (µg/mL) | 6.253 ± 5.9201 | 3.061 ± 2.6015 | 4.391 ± 8.5794 |
These will be assessed by blood samples taken at randomization visits of the study in a subgroup of participants consented to contribute samples.
| µmol/L | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Baseline Serotonin (µmol/L) | 1.894 ± 2.3104 | 1.382 ± 2.4128 | 1.915 ± 1.9254 |
| Baseline Tryptophan (µmol/L) | 56.688 ± 11.3971 | 58.115 ± 11.3080 | 55.397 ± 8.5476 |
| Baseline Taurine (µmol/L) | 97.381 ± 30.2629 | 104.615 ± 32.5454 | 108.351 ± 39.1587 |
These will be assessed by blood samples taken at specific visits of the study in a subgroup of participants consented to contribute samples.
| Percentage of change | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Interleukin-1-beta % change from baseline at Week 2 | 71.6 ± 245.5 | 45.9 ± 207.0 | 19.3 ± 55.3 |
| Interleukin-1-beta % change from baseline at Week 10 | 32.1 ± 151.1 | -23.6 ± 32.3 | 176.5 ± 678.5 |
| Interleukin-6 % change from baseline at Week 2 | 33.6 ± 138.1 | 30.7 ± 77.3 | 19.6 ± 50.6 |
| Interleukin-6 % change from baseline at Week 10 | 38.3 ± 182.9 | -10.6 ± 30.8 | 35.7 ± 165.6 |
| Interleukin-8 % change from baseline at Week 2 | 14.9 ± 48.3 | 12.9 ± 29.1 | 27.2 ± 127.7 |
| Interleukin-8 % change from baseline at Week 10 | 35.6 ± 59.4 | 19.8 ± 58.6 | 15.6 ± 51.3 |
| Interleukin-10 % change at Week 2 | 43.6 ± 119.8 | 43.4 ± 121.9 | 8.2 ± 31.0 |
| Interleukin-10 % change at Week 10 | 39.3 ± 125.1 | -14.2 ± 37.6 | 52.6 ± 283.2 |
| Interferon-lambda-1 % change at Week 2 | 1.1 ± 46.2 | 19.4 ± 77.6 | 8.3 ± 51.0 |
| Interferon-lambda-1 % change at Week 10 | 127.0 ± 152.0 | 90.9 ± 113.6 | 92.7 ± 245.1 |
| Interferon-lambda-3 % change at Week 2 | -10.5 ± 10.8 | 10.4 ± 46.0 | -4.15 ± NA |
| Interferon-lambda-3 % change at Week 10 | -16.9 ± NA | 87.1 ± 10.9 | — |
| Interferon-gamma % change at Week 2 | 43.7 ± 146.8 | 134.3 ± 320.8 | 115.4 ± 513.3 |
| Interferon-gamma % change at Week 10 | -16.1 ± 50.0 | -32.8 ± 40.8 | 5.4 ± 86.8 |
| Tumor Necrosis Factor alpha % change at Week 2 | 112.3 ± 459.7 | 65.1 ± 147.5 | 17.0 ± 59.7 |
| Tumor Necrosis Factor alpha % change at Week 10 | 76.3 ± 206.1 | 21.9 ± 72.2 | 84.9 ± 187.2 |
| Cluster of Differentiation 40 ligand % change at Week 2 | 43.6 ± 106.3 | 35.7 ± 106.1 | 60.3 ± 188.2 |
| Cluster of Differentiation 40 ligand % change at Week 10 | 36.1 ± 100.0 | 36.7 ± 113.1 | 43.2 ± 108.8 |
| Interferon gamma-induced protein 10 % change at Week 2 | 18.0 ± 68.6 | 37.0 ± 64.1 | 15.9 ± 45.6 |
| Interferon gamma-induced protein 10 % change at Week 10 | -29.5 ± 35.1 | -32.0 ± 32.7 | -10.5 ± 54.3 |
| Calprotectin % change at Week 2 | 187.7 ± 658.7 | 159.8 ± 572.9 | 65.3 ± 256.0 |
| Calprotectin % change at Week 10 | 9.6 ± 78.6 | 193.2 ± 629.7 | 219.1 ± 615.5 |
| C-reactive protein % change at Week 2 | 25.2 ± 95.4 | 185.6 ± 549.4 | 3.5 ± 25.7 |
| C-reactive protein % change at Week 10 | -8.9 ± 46.1 | 19.3 ± 55.2 | 71.6 ± 236.3 |
| Serotonin % change at Week 2 | 10.5 ± 50.7 | 274.5 ± 1257.3 | 606.1 ± 2059.9 |
| Serotonin % change at Week 10 | 51.2 ± 98.9 | 9.0 ± 65.3 | 5.1 ± 96.2 |
| Tryptophan % change at Week 2 | -1.2 ± 24.8 | 2.4 ± 15.3 | 4.4 ± 21.4 |
| Tryptophan % change at Week 10 | 8.1 ± 31.1 | 2.7 ± 16.0 | 1.2 ± 18.5 |
| Taurine % change at Week 2 | 13.1 ± 38.5 | 13.0 ± 47.1 | 29.7 ± 77.0 |
| Taurine % change at Week 10 | 12.4 ± 36.2 | 5.6 ± 38.9 | 18.0 ± 50.7 |
These will be assessed by blood samples taken at specific visits of the study in a subgroup of participants consented to contribute samples.
| µmol/L | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Baseline Retinol (µmol/L) | 1.89 ± 0.389 | 1.92 ± 0.303 | 2.05 ± 0.298 |
| Week 2 Retinol (µmol/L) | 0.42 ± 0.198 | 0.39 ± 0.092 | 1.81 ± 0.336 |
| Week 10 Retinol (µmol/L) | 0.37 ± 0.097 | 2.08 ± 0.541 | 2.07 ± 0.540 |
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.
| unitless value | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Baseline Systematic Inflammation Index | 726.4 ± 358.63 | 545.2 ± 190.27 | 628.8 ± 322.79 |
| Week 2 Systematic Inflammation Index | 626.5 ± 370.06 | 558.9 ± 169.71 | 632.2 ± 338.37 |
| Week 10 Systematic Inflammation Index | 639.5 ± 414.09 | 513.2 ± 159.02 | 563.5 ± 336.95 |
These will be assessed by blood samples taken at specific visits of the study in a subgroup of participants consented to contribute samples.
| percentage of baseline | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Retinol % change from baseline at Week 2 | -78.9 ± 5.94 | -79.5 ± 6.36 | -4.4 ± 8.24 |
| Retinol % change from baseline at Week 10 | -80.8 ± 4.274 | 0.3 ± 12.19 | 6.2 ± 21.15 |
Collected over Adverse events were collected from the time of informed consent until the Week 12 in person follow-up, or until early termination or death, whichever occurred first. Treatment emergent adverse events (TEAE) occurred from the first dose of study treatment (or worsened after first dose of study treatment) until the end of the AE collection period. Exceptions were LONG COVID symptoms (Endpoint #17) and significant cardiovascular events (Endpoints #20 & 22), both monitored until Week 24.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LAU-7b for 3 Cycles (Arm 1, AAA) | 0/90 (0%) | 1/90 (1.1%) | 71/90 (78.9%) |
| LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | 0/91 (0%) | 2/91 (2.2%) | 71/91 (78%) |
| Placebo for 3 Cycles (Arm 3, PPP) | 0/90 (0%) | 2/90 (2.2%) | 59/90 (65.6%) |
| Event | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| Femur fractureInjury, poisoning and procedural complications | 1/90 | 0/91 | 0/90 |
| CholecystitisHepatobiliary disorders | 0/90 | 0/91 | 1/90 |
| CholecystectomySurgical and medical procedures | 0/90 | 0/91 | 1/90 |
| Suicidal ideationPsychiatric disorders | 0/90 | 1/91 | 0/90 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/90 | 1/91 | 0/90 |
| Event | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) |
|---|---|---|---|
| DiarrheaGastrointestinal disorders | 17/90 | 4/91 | 9/90 |
| Abdominal painGastrointestinal disorders | 13/90 | 6/91 | 6/90 |
| Dry skinSkin and subcutaneous tissue disorders | 7/90 | 12/91 | 1/90 |
| Dry eyeEye disorders | 11/90 | 6/91 | 2/90 |
| ConstipationGastrointestinal disorders | 10/90 | 5/91 | 3/90 |
| NauseaGastrointestinal disorders | 7/90 | 10/91 | 8/90 |
| NasopharyngitisInfections and infestations | 8/90 | 8/91 | 9/90 |
| RashSkin and subcutaneous tissue disorders | 9/90 | 5/91 | 6/90 |
| Gastroesophageal reflux diseaseGastrointestinal disorders | 8/90 | 7/91 | 3/90 |
| HeadacheNervous system disorders | 8/90 | 5/91 | 3/90 |
| Age, Continuous(years) | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) | Total |
|---|---|---|---|---|
| Mean | 49.9 ± 9.26 | 46.8 ± 10.96 | 46.5 ± 10.08 | 47.8 ± 10.20 |
| Age, Customized(Participants) | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) | Total |
|---|---|---|---|---|
| Age categories — 18 to 44 years | 24 | 40 | 37 | 101 |
| Age categories — 45 to 54 years | 39 | 33 | 34 | 106 |
| Age categories — Equal or greater than 55 years | 28 | 18 | 19 | 65 |
| Sex: Female, Male(Participants) | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) | Total |
|---|---|---|---|---|
| Female | 76 | 78 | 74 | 228 |
| Male | 15 | 13 | 16 | 44 |
| Ethnicity (NIH/OMB)(Participants) | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 | 4 |
| Not Hispanic or Latino | 91 | 89 | 88 | 268 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 1 |
| White | 90 | 90 | 89 | 269 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 |
| Region of Enrollment(participants) | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) | Total |
|---|---|---|---|---|
| Canada | 91 | 91 | 90 | 272 |
| Body Weight(kilograms) | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) | Total |
|---|---|---|---|---|
| Mean | 77.18 ± 18.972 | 75.98 ± 17.375 | 81.88 ± 23.682 | 78.34 ± 20.264 |
| Body Mass Index (BMI)(kilograms/square meter) | LAU-7b for 3 Cycles (Arm 1, AAA) | LAU-7b for 1 Cycle, Then Placebo (Arm 2, APP) | Placebo for 3 Cycles (Arm 3, PPP) | Total |
|---|---|---|---|---|
| Mean | 28.14 ± 7.07 | 27.91 ± 6.29 | 29.54 ± 7.82 | 28.53 ± 7.10 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2023 to primary completion in Aug 2024, 8 months.
Results were first posted in Jan 2026, 1 year 5 months after primary completion.
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Studies of the drug tested here: Fenretinide
Post-Acute COVID-19 Syndrome →
Laurent Pharmaceuticals Inc.