A Phase 2/3 interventional study of LAU-7b and Placebo oral capsule in COVID-19 Disease, sponsored by Laurent Pharmaceuticals Inc.. Terminated at 29 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-13.
Sponsored by Laurent Pharmaceuticals Inc. · Phase 2/3, Interventional, and Treatment
A randomized, double-blind, placebo-controlled Phase 2/3 Study of LAU-7b against confirmed COVID-19 Disease in hospitalized patients at a higher risk of complications.
RESOLUTION is a multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study of LAU-7b for the treatment of COVID-19 Disease in participants at a higher risk than the general COVID-19 Disease population to develop complications while hospitalized.
The goal of the study is to evaluate the efficacy of LAU-7b therapy + standard-of-care relative to placebo + standard-of-care in participants with COVID-19 Disease with confirmed SARS-CoV-2 infection. SARS is "severe acute respiratory syndrome". CoV is " Coronavirus".
The purpose of the treatment with LAU-7b is to prevent the worsening of the health of hospitalized participants including aggravation such as recourse to mechanical ventilation and death.
The means are the direct effects of LAU-7b on the resolution of inflammation, interference with viral proliferation and protection from excessive pro-inflammatory response.
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's enrollment of 351 is above the median of 50 across 2,577 interventional studies indexed under Inflammation.
Browse Inflammation 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.
Participant must have had at least one of the following factors/co-morbidities:
Exclusion Criteria:
Health condition deemed to possibly interfere with the study endpoints and/or the safety of the participants. For example, the following conditions were considered for participation in the study, but this was not an exhaustive list. In case of doubt, the investigator was to 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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
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.
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.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
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.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
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.
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.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
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.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
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.
Active drug as LAU-7b capsules
Drug: LAU-7b
Placebo oral capsule (as inactive capsules identical to active arm)
Drug: Placebo oral capsule
LAU-7b will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
Also known as: fenretinide
Placebo will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
Primary Outcome for Phase 2: Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively)
This will be assessed through health status scoring using the WHO 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
Time frame: On Day 29
Primary Outcome for Phase 3: Proportion of Participants Requiring Mechanical Ventilation (Includes Extra-corporeal Membrane Oxygenation - ECMO) AND/OR Deceased (All Causes) by Day 60 (Ordinal Scale Scores 1-4, Inclusively)
This will be assessed through health status scoring using the WHO 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
Time frame: By Day 60
The Safety of LAU-7b Therapy, Overview.
This will be assessed through monitoring of treatment emergent adverse events and serious adverse events, vital signs including oxygen saturation and body temperature, symptom-directed physical examinations and safety laboratory tests.
Time frame: From baseline to Day 60
The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group
This will be assessed through monitoring of treatment emergent adverse events and serious adverse events, vital signs including oxygen saturation and body temperature, symptom-directed physical examinations and safety laboratory tests.
Time frame: From baseline to Day 60
Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups.
The health status was graded using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
Time frame: On Days 14 and 29
For Phase 2 Portion: Rate of All-causes Death by Day 29, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 7
This was assessed with Day 29 (and Day 60, presented separately) Health Status grading using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
Time frame: On Day 29
For Phase 3 Portion: Rate of All-causes Death by Day 29, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 7
This was assessed with Day 29 (and Day 60, presented separately) Health Status grading using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
Time frame: On Day 29
For Phase 2 Portion: Rate of All-causes Death By Day 60, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 7
This was assessed with Day 60 (and Day 29, presented separately) Health Status grading using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
Time frame: On Day 60
For Phase 3 Portion: Rate of All-causes Death By Day 60, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 7
This was assessed with Day 60 (and Day 29, presented separately) Health Status grading using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
Time frame: On Day 60
Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively)
This will be assessed through health status scoring using the WHO 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
Time frame: Day 29
For Phase 2 Portion: Rate of COVID-19 Disease-related Aggravation, Depicted by a Change From Baseline in the Ordinal Scale Score of at Least One Category
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
Time frame: From baseline to Day 60
For Phase 3 Portion: Rate of COVID-19 Disease-related Aggravation, Depicted by a Change From Baseline in the Ordinal Scale Score of at Least One Category
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
Time frame: From baseline to Day 60
For Phase 2 Only: Rate of COVID-19 Disease-related Transfer to Intensive Care Unit, Depicted by a Change From Baseline in the Ordinal Scale Score to Categories 5 or 6.
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
Time frame: From baseline to Day 60
For Phase 2 Only: Rate of COVID-19 Disease-related Transfer to Mechanical Ventilation, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 6
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
Time frame: From baseline to Day 60
For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time.
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score. Outcome measure data are counts of participants with a given change from baseline in number of categories, by treatment group. The mean change from baseline is compared between treatment groups. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
Time frame: From baseline to Day 60
For Phase 2 Only: Time to a Participant's Improvement of at Least One Category on the Ordinal Scale Health Status.
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score. If health status was not improved (remains stable or aggravates) by Day 60, it was censored at Day 60. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
Time frame: From baseline to Day 60
For Phase 2 Portion: Time to Recovery, Defined as the Time to Reach Categories 2 or 1 on the Ordinal Scale Participant Health Status (First Occurrence if More Than Once).
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score. If health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
Time frame: From baseline to Day 60
For Phase 3 Portion: Time to Recovery, Defined as the Time to Reach Categories 2 or 1 on the Ordinal Scale Participant Health Status (First Occurrence if More Than Once).
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score. If health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
Time frame: From baseline to Day 60
For Phase 2 Only: Time to Mechanical Ventilation, Defined Here as Time to Reach Category 6 on the Ordinal Scale Participant Health Status.
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score. If category 6 was skipped and the subject died (category 7), it was considered an event. Subjects with missing observations were censored at their last available assessment if they did not need mechanical ventilation while on study. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
Time frame: From baseline to Day 60
For Phase 2 Only: Time to Death, Defined Here as a Time to Reach Category 7 on the Ordinal Scale Participant Health Status, Censored to Day 60 if it Happens Later Than Day 60
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score. It was censored to Day 60 if it happened later than Day 60, or at the last available visit where the subject was alive if no further ordinal scale health status. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
Time frame: From baseline to Day 60
For Phase 2 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60
Monitoring of the hospitalization. In case of re-hospitalization within Day 60 for a given participant, the additional hospitalization time was included. Hospitalization for more than 60 days was considered 60 days in the calculation.
Time frame: From baseline to Day 60
For Phase 3 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60
Monitoring of the hospitalization. In case of re-hospitalization within Day 60 for a given participant, the additional hospitalization time was included. Hospitalization for more than 60 days was considered 60 days in the calculation.
Time frame: From baseline to Day 60
For Phase 2 Only: Time to Attain an Undetectable Viral Load in Oropharyngeal Swabs.
Intent was to compare median time to undetectable viral load between treatment groups, through oropharyngeal swabs done at specified times while hospitalized. However, almost all sites were unable to obtain serial samples until discharge of participants. Therefore, with only a handful of results (reported herein), it was not possible to estimate the time to undetectable viral load.
Time frame: Until discharge of participants, up to Day 60
The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey
This will be assessed in person or remotely, in participants reaching Days 14, 29, 45 and 60 and able to fill the questionnaire. EQ-5D-5L value was calculated based on the EQ-5D-5L user guide, and a higher value indicated better health status. The upper anchor point, full health, was 1.0 and the minimum value was 0.0.
Time frame: On Days 1, 14, 29, 45 and 60
The study was conducted in two distinct, sequential parts. The Pilot Phase 2 followed by a Phase 3 extension in a new group of subjects. The Pilot Phase 2 included 232 subjects from August 18, 2020 to July 15, 2021 and the Phase 3 extension included 119 subjects from January 28, 2022 to November 13, 2023.
| Milestone | LAU-7b | Placebo |
|---|---|---|
| Started | 117 | 115 |
| Completed | 89 | 91 |
| Not completed | 28 | 24 |
| Withdrew: Adverse event | 2 | 0 |
| Withdrew: Death | 14 | 11 |
| Withdrew: Lost to follow-up | 3 | 5 |
| Withdrew: Withdrawal by subject | 7 | 6 |
| Withdrew: Hepatic impairment | 1 | 0 |
| Withdrew: Unblinding | 1 | 0 |
| Withdrew: All other | 0 | 2 |
| Milestone | LAU-7b | Placebo |
|---|---|---|
| Started | 57 | 62 |
| Completed | 45 | 56 |
| Not completed | 12 | 6 |
| Withdrew: Death | 3 | 1 |
| Withdrew: Lost to follow-up | 4 | 2 |
| Withdrew: Patient withdrawal | 2 | 2 |
| Withdrew: Study terminated by sponsor due to futility criteria reached | 3 | 1 |
This will be assessed through health status scoring using the WHO 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
| Participants | LAU-7b Phase 2 | Placebo Phase 2 |
|---|---|---|
| ITT population, alive and free of respiratory failure. Missing data as failure. | 81 | 83 |
| Per-Protocol Population, alive and free of respiratory failure, no imputation | 65 | 65 |
| Health Status 3 + 4 at baseline alive and free of respiratory failure. Missing data as failure. | 60 | 54 |
| Health Status 5 at baseline alive and free of respiratory failure. Missing data as failure. | 21 | 29 |
| Health Status 3 + 4 at baseline with Day 29 data (no imputation) | 60 | 54 |
This will be assessed through health status scoring using the WHO 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
| Participants | LAU-7b Phase 3 | Placebo Phase 3 |
|---|---|---|
| ITT population with Day 60 data (no imputation) | 3 | 2 |
| Per-Protocol Population, alive and free of respiratory failure, no imputation | 2 | 2 |
This will be assessed through monitoring of treatment emergent adverse events and serious adverse events, vital signs including oxygen saturation and body temperature, symptom-directed physical examinations and safety laboratory tests.
| participants | LAU-7b Phase 2 | Placebo Phase 2 | LAU-7b Phase 3 | Placebo Phase 3 |
|---|---|---|---|---|
| Participants with TEAEs | 97 | 94 | 45 | 54 |
| Participants with serious TEAEs | 23 | 22 | 12 | 13 |
| Participants with at least possibly-related serious TEAEs | 0 | 0 | 0 | 0 |
| Participants with TEAEs with fatal outcome | 13 | 11 | 3 | 1 |
| Participants with TEAEs leading to treatment discontinuation | 22 | 18 | 1 | 4 |
| Participants with AE related to COVID-19 | 62 | 62 | 28 | 28 |
| Participants with suspected unexpected serious adverse reaction (SUSAR) | 0 | 0 | 0 | 0 |
This will be assessed through monitoring of treatment emergent adverse events and serious adverse events, vital signs including oxygen saturation and body temperature, symptom-directed physical examinations and safety laboratory tests.
| participants | LAU-7b Phase 2 | Placebo Phase 2 | LAU-7b Phase 3 | Placebo Phase 3 |
|---|---|---|---|---|
| Dry skin | 21 | 17 | 7 | 12 |
| Vision blurred | 18 | 20 | 5 | 5 |
| Diarrhea | 14 | 7 | 3 | 10 |
| Constipation | 10 | 12 | 2 | 4 |
| Dyspnea | 8 | 7 | 8 | 6 |
| Insomnia | 7 | 4 | 4 | 7 |
| Headache | 5 | 12 | 2 | 5 |
| Nausea | 4 | 7 | 6 | 8 |
| Cough | 0 | 0 | 6 | 7 |
The health status was graded using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
| Participants | LAU-7b Phase 2 | Placebo Phase2 | LAU-7b Phase 3 | Placebo Phase 3 |
|---|---|---|---|---|
| Health Status on Day 14 — Health Status = 1 | 2 | 1 | 0 | 0 |
| Health Status on Day 14 — Health Status = 2 | 5 | 5 | 2 | 4 |
| Health Status on Day 14 — Health Status = 3 | 33 | 32 | 20 | 28 |
| Health Status on Day 14 — Health Status = 4 | 48 | 57 | 33 | 26 |
| Health Status on Day 14 — Health Status = 5 | 9 | 4 | 0 | 3 |
| Health Status on Day 14 — Health Status = 6 | 7 | 7 | 0 | 0 |
| Health Status on Day 14 — Health Status = 7 | 1 | 1 | 0 | 0 |
| Health Status on Day 14 — Missing Health Status data | 12 | 8 | 2 | 1 |
| Health Status on Day 29 — Health Status = 1 | 44 | 42 | 36 | 30 |
| Health Status on Day 29 — Health Status = 2 | 35 | 42 | 11 | 20 |
| Health Status on Day 29 — Health Status = 3 | 2 | 0 | 2 | 1 |
| Health Status on Day 29 — Health Status = 4 | 2 | 3 | 0 | 4 |
| Health Status on Day 29 — Health Status = 5 | 2 | 0 | 0 | 0 |
| Health Status on Day 29 — Health Status = 6 | 4 | 1 | 0 | 0 |
| Health Status on Day 29 — Health Status = 7 | 0 | 0 | 0 | 0 |
| Health Status on Day 29 — Missing Health Status data | 28 | 27 | 8 | 7 |
This was assessed with Day 29 (and Day 60, presented separately) Health Status grading using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
| Participants | LAU-7b Phase 2 | Placebo Phase 2 |
|---|---|---|
| Overall ITT population — Rate of all-cause death by Day 29 | 12 | 10 |
| Overall ITT population — All other Health Status including missing data | 105 | 105 |
| Participants with Health Status 3 + 4 at baseline — Rate of all-cause death by Day 29 | 0 | 4 |
| Participants with Health Status 3 + 4 at baseline — All other Health Status including missing data | 76 | 68 |
| Participants with Health Status 5 at baseline — Rate of all-cause death by Day 29 | 12 | 6 |
| Participants with Health Status 5 at baseline — All other Health Status including missing data | 29 | 37 |
This was assessed with Day 29 (and Day 60, presented separately) Health Status grading using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
| Participants | LAU-7b Phase 3 | Placebo Phase 3 |
|---|---|---|
| Rate of all-cause death by Day 29 | 0 | 1 |
| All other Health Status including missing data | 57 | 61 |
This was assessed with Day 60 (and Day 29, presented separately) Health Status grading using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
| Participants | LAU-7b Phase 2 | Placebo Phase 2 |
|---|---|---|
| Overall ITT population — Rate of all-cause death by Day 60 | 14 | 11 |
| Overall ITT population — All other Health Status including missing data | 103 | 104 |
| Participants with Health Status 3 + 4 at baseline — Rate of all-cause death by Day 60 | 0 | 4 |
| Participants with Health Status 3 + 4 at baseline — All other Health Status including missing data | 76 | 68 |
| Participants with Health Status 5 at baseline — Rate of all-cause death by Day 60 | 14 | 7 |
| Participants with Health Status 5 at baseline — All other Health Status including missing data | 27 | 36 |
This was assessed with Day 60 (and Day 29, presented separately) Health Status grading using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
| Participants | LAU-7b Phase 3 | Placebo Phase 3 |
|---|---|---|
| Rate of all-cause death by Day 60 | 3 | 1 |
| All other Health Status including missing data | 54 | 61 |
This will be assessed through health status scoring using the WHO 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
| Participants | LAU-7b Phase 3 | Placebo Phase 3 |
|---|---|---|
| Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively) | 48 | 55 |
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
| Participants | LAU-7b Phase 2 | Placebo Phase 2 |
|---|---|---|
| Overall ITT population — Rate of COVID-19 disease-related aggravation by Day 60 | 27 | 28 |
| Overall ITT population — No aggravation by Day 60 | 90 | 87 |
| Participants with Health Status 3 + 4 at baseline — Rate of COVID-19 disease-related aggravation by Day 60 | 11 | 20 |
| Participants with Health Status 3 + 4 at baseline — No aggravation by Day 60 | 65 | 52 |
| Participants with Health Status 5 at baseline — Rate of COVID-19 disease-related aggravation by Day 60 | 16 | 8 |
| Participants with Health Status 5 at baseline — No aggravation by Day 60 | 25 | 35 |
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
| Participants | LAU-7b Phase 3 | Placebo Phase 3 |
|---|---|---|
| Rate of COVID-19 disease-related aggravation by Day 60 | 7 | 9 |
| No aggravation by Day 60 | 50 | 53 |
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
| Participants | LAU-7b Phase 2 | Placebo Phase 2 |
|---|---|---|
| Overall ITT population — Rate of COVID-19 disease-related transfer to ICU | 50 | 54 |
| Overall ITT population — No transfer to ICU | 67 | 61 |
| Participants with Health Status 3 + 4 at baseline — Rate of COVID-19 disease-related transfer to ICU | 10 | 15 |
| Participants with Health Status 3 + 4 at baseline — No transfer to ICU | 66 | 57 |
| Participants with Health Status 5 at baseline — Rate of COVID-19 disease-related transfer to ICU | 40 | 39 |
| Participants with Health Status 5 at baseline — No transfer to ICU | 1 | 4 |
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
| Participants | LAU-7b Phase 2 | Placebo Phase 2 |
|---|---|---|
| Overall ITT population — Rate of COVID-19 disease-related transfer to mechanical ventilation | 10 | 11 |
| Overall ITT population — No transfer to mechanical ventilation | 107 | 104 |
| Participants with Health Status 3 + 4 at baseline — Rate of COVID-19 disease-related transfer to mechanical ventilation | 0 | 5 |
| Participants with Health Status 3 + 4 at baseline — No transfer to mechanical ventilation | 76 | 67 |
| Participants with Health Status 5 at baseline — Rate of COVID-19 disease-related transfer to mechanical ventilation | 10 | 6 |
| Participants with Health Status 5 at baseline — No transfer to mechanical ventilation | 31 | 37 |
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score. Outcome measure data are counts of participants with a given change from baseline in number of categories, by treatment group. The mean change from baseline is compared between treatment groups. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
| Participants | LAU-7b Phase 2 | Placebo Phase 2 |
|---|---|---|
| Change from baseline on Day 14/end of hospitalization — Change of -4 categories | 0 | 0 |
| Change from baseline on Day 14/end of hospitalization — Change of -3 categories | 3 | 3 |
| Change from baseline on Day 14/end of hospitalization — Change of -2 categories | 4 | 6 |
| Change from baseline on Day 14/end of hospitalization — Change of -1 category | 38 | 48 |
| Change from baseline on Day 14/end of hospitalization — No change | 49 | 39 |
| Change from baseline on Day 14/end of hospitalization — Change of +1 category | 10 | 7 |
| Change from baseline on Day 14/end of hospitalization — Change of +2 categories | 1 | 4 |
| Change from baseline on Day 29 — Change of -4 categories | 7 | 14 |
| Change from baseline on Day 29 — Change of -3 categories | 42 | 38 |
| Change from baseline on Day 29 — Change of -2 categories | 25 | 28 |
| Change from baseline on Day 29 — Change of -1 category | 7 | 6 |
| Change from baseline on Day 29 — No change | 4 | 0 |
| Change from baseline on Day 29 — Change of +1 category | 4 | 2 |
| Change from baseline on Day 29 — Change of +2 categories | 0 | 0 |
| Change from baseline on Day 45 — Change of -4 categories | 9 | 15 |
| Change from baseline on Day 45 — Change of -3 categories | 37 | 35 |
| Change from baseline on Day 45 — Change of -2 categories | 10 | 12 |
| Change from baseline on Day 45 — Change of -1 category | 3 | 2 |
| Change from baseline on Day 45 — No change | 1 | 0 |
| Change from baseline on Day 45 — Change of +1 category | 0 | 0 |
| Change from baseline on Day 45 — Change of +2 categories | 0 | 0 |
| Change from baseline on Day 60 — Change of -4 categories | 11 | 19 |
| Change from baseline on Day 60 — Change of -3 categories | 50 | 48 |
| Change from baseline on Day 60 — Change of -2 categories | 13 | 8 |
| Change from baseline on Day 60 — Change of -1 category | 3 | 3 |
| Change from baseline on Day 60 — No change | 1 | 0 |
| Change from baseline on Day 60 — Change of +1 category | 0 | 0 |
| Change from baseline on Day 60 — Change of +2 categories | 0 | 0 |
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score. If health status was not improved (remains stable or aggravates) by Day 60, it was censored at Day 60. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
| days | LAU-7b Phase 2 | Placebo Phase 2 |
|---|---|---|
| Overall ITT population, 75% percentile value | 9 (7 to 15) | 11 (8 to 14) |
| Participants with Health Status 3 + 4 at baseline, 75% percentile value | 7 (5 to 11) | 9.5 (6 to 14) |
| Participants with Health Status 5 at baseline, 75% percentile value | 15 (9 to 26) | 12 (9 to 15) |
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score. If health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
| days | LAU-7b Phase 2 | Placebo Phase 2 |
|---|---|---|
| Overall ITT population, 75% percentile value | 14 (8 to 19) | 13 (10 to 15) |
| Participants with Health Status 3 + 4 at baseline, 75% percentile value | 8 (6 to 14) | 10 (7 to 14) |
| Participants with Health Status 5 at baseline, 75% percentile value | 21 (14 to 29) | 15 (12 to 22) |
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score. If health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
| days | LAU-7b Phase 3 | Placebo Phase 3 |
|---|---|---|
| For Phase 3 Portion: Time to Recovery, Defined as the Time to Reach Categories 2 or 1 on the Ordinal Scale Participant Health Status (First Occurrence if More Than Once). | 6 (5 to 9) | 6 (5 to 9) |
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score. If category 6 was skipped and the subject died (category 7), it was considered an event. Subjects with missing observations were censored at their last available assessment if they did not need mechanical ventilation while on study. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
| days | LAU-7b Phase 2 | Placebo Phase 2 |
|---|---|---|
| For Phase 2 Only: Time to Mechanical Ventilation, Defined Here as Time to Reach Category 6 on the Ordinal Scale Participant Health Status. | NA (NA to NA) | NA (NA to NA) |
This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score. It was censored to Day 60 if it happened later than Day 60, or at the last available visit where the subject was alive if no further ordinal scale health status. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation 7. Death
| days | LAU-7b Phase 2 | Placebo Phase 2 |
|---|---|---|
| For Phase 2 Only: Time to Death, Defined Here as a Time to Reach Category 7 on the Ordinal Scale Participant Health Status, Censored to Day 60 if it Happens Later Than Day 60 | NA (NA to NA) | NA (NA to NA) |
Monitoring of the hospitalization. In case of re-hospitalization within Day 60 for a given participant, the additional hospitalization time was included. Hospitalization for more than 60 days was considered 60 days in the calculation.
| days | LAU-7b Phase 2 | Placebo Phase 2 |
|---|---|---|
| Overall ITT population | 9.04 ± 10.51 | 8.23 ± 6.91 |
| Participants with Health Status 3 + 4 at baseline | 6.33 ± 8.39 | 6.50 ± 5.78 |
| Participants with Health Status 5 at baseline | 14.07 ± 12.18 | 11.14 ± 7.69 |
Monitoring of the hospitalization. In case of re-hospitalization within Day 60 for a given participant, the additional hospitalization time was included. Hospitalization for more than 60 days was considered 60 days in the calculation.
| days | LAU-7b Phase 3 | Placebo Phase 3 |
|---|---|---|
| For Phase 3 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60 | 5.81 ± 6.95 | 6.77 ± 6.41 |
Intent was to compare median time to undetectable viral load between treatment groups, through oropharyngeal swabs done at specified times while hospitalized. However, almost all sites were unable to obtain serial samples until discharge of participants. Therefore, with only a handful of results (reported herein), it was not possible to estimate the time to undetectable viral load.
| participants | LAU-7b Phase 2 | Placebo Phase 2 |
|---|---|---|
| Positive SARS-CoV-2 result on Day 2 | 3 | 0 |
| Positive SARS-CoV-2 result on Day 3 | 0 | 1 |
| Positive SARS-CoV-2 result on Day 5 | 0 | 1 |
| Positive SARS-CoV-2 result on Day 14 or End-of-Hospitalization | 2 | 3 |
This will be assessed in person or remotely, in participants reaching Days 14, 29, 45 and 60 and able to fill the questionnaire. EQ-5D-5L value was calculated based on the EQ-5D-5L user guide, and a higher value indicated better health status. The upper anchor point, full health, was 1.0 and the minimum value was 0.0.
| score on a scale | LAU-7b Phase 2 | Placebo Phase 2 | LAU-7b Phase 3 | Placebo Phase 3 |
|---|---|---|---|---|
| Baseline | 0.544 ± 0.346 | 0.599 ± 0.318 | 0.597 ± 0.308 | 0.517 ± 0.324 |
| Day 14 or end of hospitalization | 0.747 ± 0.274 | 0.783 ± 0.218 | 0.745 ± 0.309 | 0.660 ± 0.324 |
| Day 29 | 0.838 ± 0.238 | 0.853 ± 0.185 | 0.819 ± 0.263 | 0.754 ± 0.264 |
| Day 45 | 0.871 ± 0.250 | 0.912 ± 0.139 | 0.824 ± 0.216 | 0.745 ± 0.308 |
| Day 60 | 0.888 ± 0.195 | 0.920 ± 0.127 | 0.830 ± 0.180 | 0.774 ± 0.292 |
Collected over Adverse events were collected from the time of informed consent until the End-of-Study follow-up on Day 60, or until early termination or death, whichever occurred first.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LAU-7b Phase 2 | 14/117 (12%) | 23/117 (19.7%) | 97/117 (82.9%) |
| Placebo Phase 2 | 11/115 (9.6%) | 22/115 (19.1%) | 94/115 (81.7%) |
| LAU-7b Phase 3 | 3/57 (5.3%) | 12/57 (21.1%) | 45/57 (78.9%) |
| Placebo Phase 3 | 1/62 (1.6%) | 13/62 (21%) | 54/62 (87.1%) |
| Event | LAU-7b Phase 2 | Placebo Phase 2 | LAU-7b Phase 3 | Placebo Phase 3 |
|---|---|---|---|---|
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 9/117 | 9/115 | 0/57 | 0/62 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 5/117 | 2/115 | 1/57 | 3/62 |
| PneumoniaInfections and infestations | 1/117 | 5/115 | 1/57 | 1/62 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 0/117 | 0/115 | 2/57 | 0/62 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/117 | 1/115 | 0/57 | 2/62 |
| Atrioventricular block completeCardiac disorders | 0/117 | 0/115 | 1/57 | 0/62 |
| Cardiac arrestCardiac disorders | 1/117 | 0/115 | 1/57 | 0/62 |
| Ventricular tachycardiaCardiac disorders | 0/117 | 0/115 | 1/57 | 0/62 |
| Sudden deathGeneral disorders | 0/117 | 0/115 | 1/57 | 0/62 |
| Anaphylactic reactionImmune system disorders | 0/117 | 0/115 | 1/57 | 0/62 |
| Event | LAU-7b Phase 2 | Placebo Phase 2 | LAU-7b Phase 3 | Placebo Phase 3 |
|---|---|---|---|---|
| Dry skinSkin and subcutaneous tissue disorders | 21/117 | 17/115 | 7/57 | 12/62 |
| Vision blurredEye disorders | 18/117 | 20/115 | 5/57 | 5/62 |
| DiarrhoeaGastrointestinal disorders | 14/117 | 7/115 | 3/57 | 10/62 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 8/117 | 6/115 | 8/57 | 4/62 |
| NauseaGastrointestinal disorders | 4/117 | 7/115 | 6/57 | 8/62 |
| InsomniaPsychiatric disorders | 7/117 | 4/115 | 4/57 | 7/62 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/117 | 5/115 | 6/57 | 7/62 |
| ConstipationGastrointestinal disorders | 10/117 | 12/115 | 2/57 | 4/62 |
| HeadacheNervous system disorders | 5/117 | 12/115 | 2/57 | 5/62 |
| PyrexiaGeneral disorders | 5/117 | 3/115 | 2/57 | 6/62 |
The Pilot Phase 2 and the Phase 3 extensions are distinct, sequential portions with different subjects.
| Age, Continuous(years) | LAU-7b Phase 2 | Placebo Phase 2 | LAU-7b Phase 3 | Placebo Phase 3 | Total |
|---|---|---|---|---|---|
| Mean | 57.5 ± 13.5 | 56.7 ± 12.4 | 68.1 ± 12.97 | 65.9 ± 15.91 | 61.1 ± 15 |
| Age, Customized(Participants) | LAU-7b Phase 2 | Placebo Phase 2 | LAU-7b Phase 3 | Placebo Phase 3 | Total |
|---|---|---|---|---|---|
| 18 to 44 years | 22 | 22 | 4 | 6 | 54 |
| 45 to 69 years | 70 | 73 | 18 | 26 | 187 |
| 70 years and older | 25 | 20 | 35 | 30 | 110 |
| Sex: Female, Male(Participants) | LAU-7b Phase 2 | Placebo Phase 2 | LAU-7b Phase 3 | Placebo Phase 3 | Total |
|---|---|---|---|---|---|
| Female | 46 | 45 | 30 | 28 | 149 |
| Male | 71 | 70 | 27 | 34 | 202 |
| Ethnicity (NIH/OMB)(Participants) | LAU-7b Phase 2 | Placebo Phase 2 | LAU-7b Phase 3 | Placebo Phase 3 | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 10 | 17 | 4 | 5 | 36 |
| Not Hispanic or Latino | 106 | 98 | 51 | 56 | 311 |
| Unknown or Not Reported | 1 | 0 | 2 | 1 | 4 |
| Race (NIH/OMB)(Participants) | LAU-7b Phase 2 | Placebo Phase 2 | LAU-7b Phase 3 | Placebo Phase 3 | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 0 | 0 | 2 |
| Asian | 5 | 0 | 1 | 3 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 0 | 1 |
| Black or African American | 14 | 19 | 7 | 7 | 47 |
| White | 92 | 86 | 46 | 48 | 272 |
| More than one race | 0 | 0 | 0 | 2 | 2 |
| Unknown or Not Reported | 5 | 9 | 2 | 2 | 18 |
| Region of Enrollment(participants) | LAU-7b Phase 2 | Placebo Phase 2 | LAU-7b Phase 3 | Placebo Phase 3 | Total |
|---|---|---|---|---|---|
| Canada | 37 | 35 | 2 | 2 | 76 |
| United States | 80 | 80 | 55 | 60 | 275 |
| Health Status of the Patient on the 7-point Ordinal Scale(Participants) | LAU-7b Phase 2 | Placebo Phase 2 | LAU-7b Phase 3 | Placebo Phase 3 | Total |
|---|---|---|---|---|---|
| Health Status at baseline = 3 | 17 | 12 | 19 | 19 | 67 |
| Health Status at baseline = 4 | 59 | 60 | 37 | 43 | 199 |
| Health Status at baseline = 5 | 41 | 43 | 1 | 0 | 85 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2020 to primary completion in Feb 2024, 41 months.
Results were first posted in Nov 2025, 1 year 8 months after primary completion.
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Studies of the drug tested here: Fenretinide
Laurent Pharmaceuticals Inc.