COVID-19 Disease
Conditions
Keywords
Inflammation, Antiviral, Host-directed treatment, Docosahexaenoic acid, Pro-resolving
Brief summary
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.
Detailed description
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.
Interventions
DRUGLAU-7b
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.
DRUGPlacebo oral capsule
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.
Sponsors
Laurent Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Patients will be randomly assigned to take either the active drug (LAU-7b capsule) or a matching inactive placebo (inactive capsule)
Intervention model description
Double-blind, randomized, parallel groups and placebo-controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant exhibited symptoms \[Extension Phase 3 study only: (including at least one lower respiratory symptom such as shortness of breath or dyspnea)\] of COVID-19 disease at screening and/or since the start of their hospitalization (may have included treated symptoms) 2. Participant was 18 years and older, of either gender 3. Participant must have had at least one of the following factors/co-morbidities: 1. Controlled or uncontrolled diabetes 2. Pre-existing cardiovascular disease, including hypertension 3. Pre-existing respiratory disease such as chronic obstructive pulmonary disease(COPD), asthma, emphysema 4. Active \[Extension Phase 3 study only: or a former smoker\] with 20 pack-years of smoking history 5. Obesity as depicted by BMI ≥30 kg/m2 6. Laboratory tests indicative of a higher risk of COVID-19-related complications, such as troponin \>1.5 the upper limit of normal (ULN), \[Extension Phase 3 study only: D-dimer \>3.0 ULN\] and/or C reactive protein (CRP) \>1.5 ULN 7. Aged 70 years and older who, based on the judgment of the investigator, was at a higher risk of developing complications 4. Participant had a documented positive test for the SARS-CoV-2 virus \[Pilot Phase 2 study only: or was suspected to be positive and with a test result pending\]. \[Extension Phase 3 study only: Co-infection with other viral respiratory infections was allowed and had to be documented in medical history\] 5. Participant was under observation by, or admitted to, a controlled facility or hospital \[Extension Phase 3 study only: for no more than 48 hours (72 hours from amendment 3 onwards) before screening, including any prior stay in another hospital\] to receive standard of care (SoC) for COVID-19 disease 6. \[Pilot Phase 2 study only: Participant's hs was 3, 4, or 5 on the WHO ordinal scale and not previously a 6\] \[Extension Phase 3 study only: 3 or 4 on the World Health Organization (WHO) ordinal scale and not previously a 5 or a 6\] 7. If female, participant was either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who were capable of conception had to be practicing a highly effective method of birth control (acceptable methods included intrauterine device, complete abstinence, spermicide + barrier, male partner surgical sterilization, or hormonal contraception) during the study and through 30 days after the last dose of the study medication. Periodical abstinence was not classified as an effective method of birth control. A pregnancy test had to be negative at the Screening Visit 8. Participant had the ability to understand and give informed consent, which could have been verbal with a witness, according to local requirements 9. Participant was deemed capable of adequate compliance including attending scheduled visits for the duration of the study 10. Participant was able to swallow the study drug capsules
Exclusion criteria
1. Pregnancy or breastfeeding 2. Health condition deemed to possibly interfere with the study endpoints and/or the safety of the participants. For example, the following conditions were considered contraindicated 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: 1. Presence of inherited retinitis pigmentosa 2. Presence or history of liver failure (Child-Pugh B or C) 3. Presence or history of stage 4 severe chronic kidney disease or dialysis requirement 4. Febrile neutropenia 5. \[Pilot Phase 2 study: Presence of active cancer treated with systemic chemotherapy or radiotherapy\]\[Extension Phase 3 study: Presence of end-stage cancer\] 3. Known history of a severe allergy or sensitivity to retinoids, or with known allergies to excipients in the oral capsule formulation used in the study 4. Participation in another drug clinical trial within 30 days (or a minimum of 5 t½) prior to screening, except ongoing participation in non-interventional studies 5. Calculated creatinine clearance (CrCl), using the Cockroft-Gault equation for example \[Pilot Phase 2 study: \<60 mL/min\] \[Extension Phase 3 study: \<30 mL/min)\] 6. Presence of total bilirubin \>1.5 x ULN (in the absence of demonstrated Gilbert's syndrome), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>2.5 x ULN 7. \[Extension Phase 3 study only: Subject expected to be transferred to ICU or die in the next 24 hours\]
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome for Phase 2: Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively) | On Day 29 | 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 |
| 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) | By Day 60 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | On Days 14 and 29 | 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 |
| 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 | On Day 29 | 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 |
| 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 | On Day 29 | 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 |
| 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 | On Day 60 | 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 |
| 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 | On Day 60 | 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 |
| Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively) | Day 29 | 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 |
| 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 | From baseline to Day 60 | 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 |
| 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 | From baseline to Day 60 | 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 |
| 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. | From baseline to Day 60 | 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 |
| 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 | From baseline to Day 60 | 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 |
| The Safety of LAU-7b Therapy, Overview. | From baseline to Day 60 | 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. |
| For Phase 2 Only: Time to a Participant's Improvement of at Least One Category on the Ordinal Scale Health Status. | From baseline to 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. 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 |
| 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). | From baseline to 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. 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 |
| 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). | From baseline to 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. 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 |
| For Phase 2 Only: Time to Mechanical Ventilation, Defined Here as Time to Reach Category 6 on the Ordinal Scale Participant Health Status. | From baseline to 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. 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 |
| 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 | From baseline to 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 |
| For Phase 2 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60 | From baseline to Day 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. |
| For Phase 3 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60 | From baseline to Day 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. |
| For Phase 2 Only: Time to Attain an Undetectable Viral Load in Oropharyngeal Swabs. | Until discharge of participants, up to Day 60 | 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. |
| The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | On Days 1, 14, 29, 45 and 60 | 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. |
| For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | From baseline to 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. 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 |
| The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | From baseline to Day 60 | 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. |
Countries
Canada, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| LAU-7b Phase 2 Active drug as LAU-7b capsules
LAU-7b: 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. | 117 |
| Placebo Phase 2 Placebo oral capsule (as inactive capsules identical to active arm)
Placebo oral capsule: 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. | 115 |
| LAU-7b Phase 3 Active drug as LAU-7b capsules
LAU-7b: 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. | 57 |
| Placebo Phase 3 Placebo oral capsule (as inactive capsules identical to active arm)
Placebo oral capsule: 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. | 62 |
| Total | 351 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Phase 3 Extension | Death | 3 | 1 |
| Phase 3 Extension | Lost to Follow-up | 4 | 2 |
| Phase 3 Extension | Patient withdrawal | 2 | 2 |
| Phase 3 Extension | Study terminated by sponsor due to futility criteria reached | 3 | 1 |
| Pilot Phase 2 | Adverse Event | 2 | 0 |
| Pilot Phase 2 | All other | 0 | 2 |
| Pilot Phase 2 | Death | 14 | 11 |
| Pilot Phase 2 | Hepatic impairment | 1 | 0 |
| Pilot Phase 2 | Lost to Follow-up | 3 | 5 |
| Pilot Phase 2 | Unblinding | 1 | 0 |
| Pilot Phase 2 | Withdrawal by Subject | 7 | 6 |
Baseline characteristics
| Characteristic | LAU-7b Phase 2 | Placebo Phase 2 | LAU-7b Phase 3 | Placebo Phase 3 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 57.5 years STANDARD_DEVIATION 13.5 | 56.7 years STANDARD_DEVIATION 12.4 | 68.1 years STANDARD_DEVIATION 12.97 | 65.9 years STANDARD_DEVIATION 15.91 | 61.1 years STANDARD_DEVIATION 15 |
| Age, Customized 18 to 44 years | 22 Participants | 22 Participants | 4 Participants | 6 Participants | 54 Participants |
| Age, Customized 45 to 69 years | 70 Participants | 73 Participants | 18 Participants | 26 Participants | 187 Participants |
| Age, Customized 70 years and older | 25 Participants | 20 Participants | 35 Participants | 30 Participants | 110 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 17 Participants | 4 Participants | 5 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 106 Participants | 98 Participants | 51 Participants | 56 Participants | 311 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 4 Participants |
| Health Status of the Patient on the 7-point Ordinal Scale Health Status at baseline = 3 | 17 Participants | 12 Participants | 19 Participants | 19 Participants | 67 Participants |
| Health Status of the Patient on the 7-point Ordinal Scale Health Status at baseline = 4 | 59 Participants | 60 Participants | 37 Participants | 43 Participants | 199 Participants |
| Health Status of the Patient on the 7-point Ordinal Scale Health Status at baseline = 5 | 41 Participants | 43 Participants | 1 Participants | 0 Participants | 85 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 0 Participants | 1 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 19 Participants | 7 Participants | 7 Participants | 47 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 9 Participants | 2 Participants | 2 Participants | 18 Participants |
| Race (NIH/OMB) White | 92 Participants | 86 Participants | 46 Participants | 48 Participants | 272 Participants |
| Region of Enrollment Canada | 37 participants | 35 participants | 2 participants | 2 participants | 76 participants |
| Region of Enrollment United States | 80 participants | 80 participants | 55 participants | 60 participants | 275 participants |
| Sex: Female, Male Female | 46 Participants | 45 Participants | 30 Participants | 28 Participants | 149 Participants |
| Sex: Female, Male Male | 71 Participants | 70 Participants | 27 Participants | 34 Participants | 202 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 14 / 117 | 11 / 115 | 3 / 57 | 1 / 62 |
| other Total, other adverse events | 97 / 117 | 94 / 115 | 45 / 57 | 54 / 62 |
| serious Total, serious adverse events | 23 / 117 | 22 / 115 | 12 / 57 | 13 / 62 |
Outcome results
Primary
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
Population: ITT population (received a minimum of one study treatment dose), per-protocol (PP) population (received a minimum of 12 days of study treatment and no major protocol deviation)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LAU-7b Phase 2 | Primary Outcome for Phase 2: Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively) | ITT population, alive and free of respiratory failure. Missing data as failure. | 81 Participants |
| LAU-7b Phase 2 | Primary Outcome for Phase 2: Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively) | Per-Protocol Population, alive and free of respiratory failure, no imputation | 65 Participants |
| LAU-7b Phase 2 | Primary Outcome for Phase 2: Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively) | Health Status 3 + 4 at baseline alive and free of respiratory failure. Missing data as failure. | 60 Participants |
| LAU-7b Phase 2 | Primary Outcome for Phase 2: Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively) | Health Status 5 at baseline alive and free of respiratory failure. Missing data as failure. | 21 Participants |
| LAU-7b Phase 2 | Primary Outcome for Phase 2: Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively) | Health Status 3 + 4 at baseline with Day 29 data (no imputation) | 60 Participants |
| Placebo Phase 2 | Primary Outcome for Phase 2: Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively) | Health Status 3 + 4 at baseline with Day 29 data (no imputation) | 54 Participants |
| Placebo Phase 2 | Primary Outcome for Phase 2: Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively) | ITT population, alive and free of respiratory failure. Missing data as failure. | 83 Participants |
| Placebo Phase 2 | Primary Outcome for Phase 2: Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively) | Health Status 5 at baseline alive and free of respiratory failure. Missing data as failure. | 29 Participants |
| Placebo Phase 2 | Primary Outcome for Phase 2: Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively) | Per-Protocol Population, alive and free of respiratory failure, no imputation | 65 Participants |
| Placebo Phase 2 | Primary Outcome for Phase 2: Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively) | Health Status 3 + 4 at baseline alive and free of respiratory failure. Missing data as failure. | 54 Participants |
Comparison: Participants with health status data missing on Day 29 were treated as non-responders, where a non-responder was defined as not reaching a health status of 1-4.p-value: 0.737795% CI: [-15, 9]Fisher Exact
Comparison: Participants from Per-Protocol population and with available Day 29 health status datap-value: 195% CI: [-10, 2.8]Fisher Exact
Comparison: Multivariable logistic regression was constructed for the proportion of participants alive and free of respiratory failure on Day 29 as the outcome variable by screening baseline covariates using stepwise technique with an alpha of 0.1 as the entry and stay criterion, and treatment group was forced to remain in the model. Health status at baseline was used as a continuous variablep-value: 0.017795% CI: [0.359, 0.907]Regression, Logistic
Comparison: Participants in the ITT population with baseline Health Status of 3 + 4 grouped together with imputation of failure for missing Day 29 datap-value: 0.353795% CI: [-10.2, 18.2]Fisher Exact
Comparison: Participants in the ITT population with baseline Health Status of 5 and imputation of failure for missing Day 29 datap-value: 0.95995% CI: [-36.6, 5.4]Fisher Exact
Comparison: Participants in the ITT population with baseline Health Status of 3 + 4 and available Day 29 health status data (no imputation)p-value: 0.055395% CI: [0.4, 17.1]Fisher Exact
Primary
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
Population: ITT population (received a minimum of one study treatment dose), per-protocol (PP) population (received a minimum of 12 days of study treatment and no major protocol deviation)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LAU-7b Phase 2 | 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) | ITT population with Day 60 data (no imputation) | 3 Participants |
| LAU-7b Phase 2 | 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) | Per-Protocol Population, alive and free of respiratory failure, no imputation | 2 Participants |
| Placebo Phase 2 | 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) | ITT population with Day 60 data (no imputation) | 2 Participants |
| Placebo Phase 2 | 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) | Per-Protocol Population, alive and free of respiratory failure, no imputation | 2 Participants |
Comparison: ITT population with Day 60 health status/survival datap-value: 0.6695% CI: [-6.9, 13.9]Fisher Exact
Comparison: Per-Protocol population with Day 60 health status/survival datap-value: 195% CI: [-10.6, 12.6]Fisher Exact
Secondary
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
Population: ITT population; this endpoint was analyzed for Phase 2 only. Due to early termination of Phase 3, this endpoint was planned not to be analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 60 | Change of +1 category | 0 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 14/end of hospitalization | No change | 49 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 14/end of hospitalization | Change of +2 categories | 1 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 29 | Change of -3 categories | 42 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 29 | Change of -2 categories | 25 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 29 | Change of -1 category | 7 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 29 | No change | 4 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 29 | Change of +1 category | 4 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 29 | Change of +2 categories | 0 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 45 | Change of -4 categories | 9 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 45 | Change of -3 categories | 37 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 45 | Change of -2 categories | 10 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 45 | Change of -1 category | 3 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 45 | No change | 1 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 45 | Change of +1 category | 0 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 45 | Change of +2 categories | 0 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 60 | Change of -4 categories | 11 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 60 | Change of -1 category | 3 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 60 | No change | 1 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 60 | Change of +2 categories | 0 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 14/end of hospitalization | Change of -3 categories | 3 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 14/end of hospitalization | Change of -2 categories | 4 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 14/end of hospitalization | Change of -1 category | 38 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 14/end of hospitalization | Change of +1 category | 10 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 29 | Change of -4 categories | 7 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 60 | Change of -3 categories | 50 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 60 | Change of -2 categories | 13 Participants |
| LAU-7b Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 14/end of hospitalization | Change of -4 categories | 0 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 45 | Change of +1 category | 0 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 14/end of hospitalization | Change of -3 categories | 3 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 14/end of hospitalization | No change | 39 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 14/end of hospitalization | Change of +1 category | 7 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 45 | Change of +2 categories | 0 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 14/end of hospitalization | Change of +2 categories | 4 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 29 | Change of -3 categories | 38 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 60 | Change of -4 categories | 19 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 29 | Change of -2 categories | 28 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 60 | Change of -3 categories | 48 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 29 | Change of -1 category | 6 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 60 | Change of -2 categories | 8 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 29 | No change | 0 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 14/end of hospitalization | Change of -2 categories | 6 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 29 | Change of +1 category | 2 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 60 | Change of -1 category | 3 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 29 | Change of +2 categories | 0 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 60 | No change | 0 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 45 | Change of -4 categories | 15 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 60 | Change of +1 category | 0 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 45 | Change of -3 categories | 35 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 14/end of hospitalization | Change of -1 category | 48 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 45 | Change of -2 categories | 12 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 60 | Change of +2 categories | 0 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 45 | Change of -1 category | 2 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 14/end of hospitalization | Change of -4 categories | 0 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 45 | No change | 0 Participants |
| Placebo Phase 2 | For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time. | Change from baseline on Day 29 | Change of -4 categories | 14 Participants |
Comparison: Null hypothesis of no differencep-value: 0.646Mixed Models Analysis
Secondary
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
Population: ITT population; this endpoint was analyzed for Phase 2 only. Due to early termination of Phase 3, this endpoint was planned not to be analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAU-7b Phase 2 | 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. | Overall ITT population | No transfer to ICU | 67 Participants |
| LAU-7b Phase 2 | 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. | Participants with Health Status 3 + 4 at baseline | Rate of COVID-19 disease-related transfer to ICU | 10 Participants |
| LAU-7b Phase 2 | 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. | Participants with Health Status 3 + 4 at baseline | No transfer to ICU | 66 Participants |
| LAU-7b Phase 2 | 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. | Participants with Health Status 5 at baseline | Rate of COVID-19 disease-related transfer to ICU | 40 Participants |
| LAU-7b Phase 2 | 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. | Participants with Health Status 5 at baseline | No transfer to ICU | 1 Participants |
| LAU-7b Phase 2 | 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. | Overall ITT population | Rate of COVID-19 disease-related transfer to ICU | 50 Participants |
| Placebo Phase 2 | 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. | Participants with Health Status 5 at baseline | No transfer to ICU | 4 Participants |
| Placebo Phase 2 | 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. | Overall ITT population | No transfer to ICU | 61 Participants |
| Placebo Phase 2 | 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. | Participants with Health Status 5 at baseline | Rate of COVID-19 disease-related transfer to ICU | 39 Participants |
| Placebo Phase 2 | 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. | Participants with Health Status 3 + 4 at baseline | Rate of COVID-19 disease-related transfer to ICU | 15 Participants |
| Placebo Phase 2 | 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. | Overall ITT population | Rate of COVID-19 disease-related transfer to ICU | 54 Participants |
| Placebo Phase 2 | 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. | Participants with Health Status 3 + 4 at baseline | No transfer to ICU | 57 Participants |
Comparison: Calculated based on the total number of participants who had the event prior to or with Day 60 assessment available within each group.p-value: 0.8886Fisher Exact
Comparison: Calculated based on the total number of participants with Health Status 3 + 4 at baseline who had the event prior to or with Day 60 assessment available within each group.p-value: 0.2735Fisher Exact
Comparison: Calculated based on the total number of participants with Health Status 5 at baseline who had the event prior to or with Day 60 assessment available within each group.p-value: 0.3604Fisher Exact
Secondary
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
Population: ITT population; this endpoint was analyzed for Phase 2 only. Due to early termination of Phase 3, this endpoint was planned not to be analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAU-7b Phase 2 | 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 | Overall ITT population | Rate of COVID-19 disease-related transfer to mechanical ventilation | 10 Participants |
| LAU-7b Phase 2 | 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 | Overall ITT population | No transfer to mechanical ventilation | 107 Participants |
| LAU-7b Phase 2 | 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 | Participants with Health Status 3 + 4 at baseline | Rate of COVID-19 disease-related transfer to mechanical ventilation | 0 Participants |
| LAU-7b Phase 2 | 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 | Participants with Health Status 3 + 4 at baseline | No transfer to mechanical ventilation | 76 Participants |
| LAU-7b Phase 2 | 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 | Participants with Health Status 5 at baseline | Rate of COVID-19 disease-related transfer to mechanical ventilation | 10 Participants |
| LAU-7b Phase 2 | 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 | Participants with Health Status 5 at baseline | No transfer to mechanical ventilation | 31 Participants |
| Placebo Phase 2 | 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 | Participants with Health Status 5 at baseline | Rate of COVID-19 disease-related transfer to mechanical ventilation | 6 Participants |
| Placebo Phase 2 | 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 | Overall ITT population | Rate of COVID-19 disease-related transfer to mechanical ventilation | 11 Participants |
| Placebo Phase 2 | 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 | Participants with Health Status 3 + 4 at baseline | No transfer to mechanical ventilation | 67 Participants |
| Placebo Phase 2 | 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 | Overall ITT population | No transfer to mechanical ventilation | 104 Participants |
| Placebo Phase 2 | 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 | Participants with Health Status 5 at baseline | No transfer to mechanical ventilation | 37 Participants |
| Placebo Phase 2 | 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 | Participants with Health Status 3 + 4 at baseline | Rate of COVID-19 disease-related transfer to mechanical ventilation | 5 Participants |
Comparison: Calculated based on the total number of participants who had the event prior to or with Day 60 assessment available within each group.p-value: 1Fisher Exact
Comparison: Calculated based on the total number of participants with Health Status 3 + 4 at baseline who had the event prior to or with Day 60 assessment available within each group.p-value: 0.0253Fisher Exact
Comparison: Calculated based on the total number of participants with Health Status 5 at baseline who had the event prior to or with Day 60 assessment available within each group.p-value: 0.2729Fisher Exact
Secondary
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
Population: ITT population; this endpoint was analyzed for Phase 2 only. Due to early termination of Phase 3, this endpoint was planned not to be analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LAU-7b Phase 2 | For Phase 2 Only: Time to a Participant's Improvement of at Least One Category on the Ordinal Scale Health Status. | Overall ITT population, 75% percentile value | 9 days |
| LAU-7b Phase 2 | For Phase 2 Only: Time to a Participant's Improvement of at Least One Category on the Ordinal Scale Health Status. | Participants with Health Status 3 + 4 at baseline, 75% percentile value | 7 days |
| LAU-7b Phase 2 | For Phase 2 Only: Time to a Participant's Improvement of at Least One Category on the Ordinal Scale Health Status. | Participants with Health Status 5 at baseline, 75% percentile value | 15 days |
| Placebo Phase 2 | For Phase 2 Only: Time to a Participant's Improvement of at Least One Category on the Ordinal Scale Health Status. | Overall ITT population, 75% percentile value | 11 days |
| Placebo Phase 2 | For Phase 2 Only: Time to a Participant's Improvement of at Least One Category on the Ordinal Scale Health Status. | Participants with Health Status 3 + 4 at baseline, 75% percentile value | 9.5 days |
| Placebo Phase 2 | For Phase 2 Only: Time to a Participant's Improvement of at Least One Category on the Ordinal Scale Health Status. | Participants with Health Status 5 at baseline, 75% percentile value | 12 days |
Comparison: If health status was not improved (remains stable or aggravates) by Day 60, it was censored at Day 60. Overall ITT population.p-value: 0.8722Log Rank
Comparison: If health status was not improved (remains stable or aggravates) by Day 60, it was censored at Day 60. Participants with Health Status 3 + 4 at baseline.p-value: 0.539Log Rank
Comparison: If health status was not improved (remains stable or aggravates) by Day 60, it was censored at Day 60. Participants with Health Status 5 at baseline.p-value: 0.2319Log Rank
Secondary
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
Population: In Phase 2 portion Only: Participants sampled after randomization during hospitalization. Too few samples collected, intended endpoint not estimable. Not an endpoint for Phase 3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LAU-7b Phase 2 | For Phase 2 Only: Time to Attain an Undetectable Viral Load in Oropharyngeal Swabs. | Positive SARS-CoV-2 result on Day 2 | 3 participants |
| LAU-7b Phase 2 | For Phase 2 Only: Time to Attain an Undetectable Viral Load in Oropharyngeal Swabs. | Positive SARS-CoV-2 result on Day 3 | 0 participants |
| LAU-7b Phase 2 | For Phase 2 Only: Time to Attain an Undetectable Viral Load in Oropharyngeal Swabs. | Positive SARS-CoV-2 result on Day 5 | 0 participants |
| LAU-7b Phase 2 | For Phase 2 Only: Time to Attain an Undetectable Viral Load in Oropharyngeal Swabs. | Positive SARS-CoV-2 result on Day 14 or End-of-Hospitalization | 2 participants |
| Placebo Phase 2 | For Phase 2 Only: Time to Attain an Undetectable Viral Load in Oropharyngeal Swabs. | Positive SARS-CoV-2 result on Day 14 or End-of-Hospitalization | 3 participants |
| Placebo Phase 2 | For Phase 2 Only: Time to Attain an Undetectable Viral Load in Oropharyngeal Swabs. | Positive SARS-CoV-2 result on Day 2 | 0 participants |
| Placebo Phase 2 | For Phase 2 Only: Time to Attain an Undetectable Viral Load in Oropharyngeal Swabs. | Positive SARS-CoV-2 result on Day 5 | 1 participants |
| Placebo Phase 2 | For Phase 2 Only: Time to Attain an Undetectable Viral Load in Oropharyngeal Swabs. | Positive SARS-CoV-2 result on Day 3 | 1 participants |
Secondary
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
Population: ITT population; this endpoint was analyzed for Phase 2 only. Due to early termination of Phase 3, this endpoint was planned not to be analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| LAU-7b 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 days |
| 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 days |
Secondary
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
Population: ITT population; this endpoint was analyzed for Phase 2 only. Due to early termination of Phase 3, this endpoint was planned not to be analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| LAU-7b 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 days |
| 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 days |
Secondary
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
Population: ITT population, in this portion of study, participants with Health Status 3, 4 or 5 were enrolled.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LAU-7b Phase 2 | For Phase 2 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60 | Overall ITT population | 9.04 days | Standard Deviation 10.51 |
| LAU-7b Phase 2 | For Phase 2 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60 | Participants with Health Status 3 + 4 at baseline | 6.33 days | Standard Deviation 8.39 |
| LAU-7b Phase 2 | For Phase 2 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60 | Participants with Health Status 5 at baseline | 14.07 days | Standard Deviation 12.18 |
| Placebo Phase 2 | For Phase 2 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60 | Overall ITT population | 8.23 days | Standard Deviation 6.91 |
| Placebo Phase 2 | For Phase 2 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60 | Participants with Health Status 3 + 4 at baseline | 6.50 days | Standard Deviation 5.78 |
| Placebo Phase 2 | For Phase 2 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60 | Participants with Health Status 5 at baseline | 11.14 days | Standard Deviation 7.69 |
Comparison: Overall ITT population. The Kolmogorov-Smirnov test and visual check indicated the normality assumption was rejected, and two-sided Wilcoxon rank sum test was used to obtain the P-value.p-value: 0.2706Wilcoxon (Mann-Whitney)
Comparison: Participants with Health Status 3 + 4 at baseline. The Kolmogorov-Smirnov test and visual check indicated the normality assumption was rejected, and two-sided Wilcoxon rank sum test was used to obtain the P-value.p-value: 0.0974Wilcoxon (Mann-Whitney)
Comparison: Participants with Health Status 5 at baseline. The Kolmogorov-Smirnov test and visual check indicated the normality assumption was rejected, and two-sided Wilcoxon rank sum test was used to obtain the P-value.p-value: 0.5549Wilcoxon (Mann-Whitney)
Secondary
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
Population: ITT population; In this portion of study, participants with Health Status 3,4 and 5 were enrolled.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAU-7b Phase 2 | 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 | Participants with Health Status 5 at baseline | Rate of all-cause death by Day 29 | 12 Participants |
| LAU-7b Phase 2 | 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 | Overall ITT population | All other Health Status including missing data | 105 Participants |
| LAU-7b Phase 2 | 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 | Participants with Health Status 3 + 4 at baseline | Rate of all-cause death by Day 29 | 0 Participants |
| LAU-7b Phase 2 | 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 | Participants with Health Status 3 + 4 at baseline | All other Health Status including missing data | 76 Participants |
| LAU-7b Phase 2 | 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 | Participants with Health Status 5 at baseline | All other Health Status including missing data | 29 Participants |
| LAU-7b Phase 2 | 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 | Overall ITT population | Rate of all-cause death by Day 29 | 12 Participants |
| Placebo Phase 2 | 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 | Participants with Health Status 5 at baseline | All other Health Status including missing data | 37 Participants |
| Placebo Phase 2 | 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 | Overall ITT population | Rate of all-cause death by Day 29 | 10 Participants |
| Placebo Phase 2 | 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 | Participants with Health Status 5 at baseline | Rate of all-cause death by Day 29 | 6 Participants |
| Placebo Phase 2 | 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 | Overall ITT population | All other Health Status including missing data | 105 Participants |
| Placebo Phase 2 | 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 | Participants with Health Status 3 + 4 at baseline | All other Health Status including missing data | 68 Participants |
| Placebo Phase 2 | 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 | Participants with Health Status 3 + 4 at baseline | Rate of all-cause death by Day 29 | 4 Participants |
Comparison: Total number of participants in the overall ITT population who had the event prior to or with Day 29 assessment available.p-value: 0.8222Fisher Exact
Comparison: Total number of participants with Health Status 3 + 4 at baseline who had the event prior to or with Day 29 assessment available.p-value: 0.0536Fisher Exact
Comparison: Total number of participants with Health Status 5 at baseline who had the event prior to or with Day 29 assessment available.p-value: 0.1131Fisher Exact
Secondary
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
Population: ITT population; in this portion of study, participants with Health Status 3,4 and 5 were enrolled.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAU-7b Phase 2 | 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 | Overall ITT population | Rate of all-cause death by Day 60 | 14 Participants |
| LAU-7b Phase 2 | 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 | Overall ITT population | All other Health Status including missing data | 103 Participants |
| LAU-7b Phase 2 | 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 | Participants with Health Status 3 + 4 at baseline | Rate of all-cause death by Day 60 | 0 Participants |
| LAU-7b Phase 2 | 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 | Participants with Health Status 3 + 4 at baseline | All other Health Status including missing data | 76 Participants |
| LAU-7b Phase 2 | 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 | Participants with Health Status 5 at baseline | Rate of all-cause death by Day 60 | 14 Participants |
| LAU-7b Phase 2 | 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 | Participants with Health Status 5 at baseline | All other Health Status including missing data | 27 Participants |
| Placebo Phase 2 | 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 | Participants with Health Status 5 at baseline | Rate of all-cause death by Day 60 | 7 Participants |
| Placebo Phase 2 | 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 | Overall ITT population | Rate of all-cause death by Day 60 | 11 Participants |
| Placebo Phase 2 | 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 | Participants with Health Status 3 + 4 at baseline | All other Health Status including missing data | 68 Participants |
| Placebo Phase 2 | 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 | Overall ITT population | All other Health Status including missing data | 104 Participants |
| Placebo Phase 2 | 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 | Participants with Health Status 5 at baseline | All other Health Status including missing data | 36 Participants |
| Placebo Phase 2 | 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 | Participants with Health Status 3 + 4 at baseline | Rate of all-cause death by Day 60 | 4 Participants |
Comparison: Total number of participants in the overall ITT population who had the event prior to or with Day 60 assessment available.p-value: 0.6689Fisher Exact
Comparison: Total number of participants with Health Status 3 + 4 at baseline who had the event prior to or with Day 60 assessment available.p-value: 0.0536Fisher Exact
Comparison: Total number of participants with Health Status 5 at baseline who had the event prior to or with Day 60 assessment available.p-value: 0.0786Fisher Exact
Secondary
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
Population: ITT population; in this portion of study, participants with Health Status of 3, 4 and 5 were enrolled.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAU-7b Phase 2 | 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 | Overall ITT population | No aggravation by Day 60 | 90 Participants |
| LAU-7b Phase 2 | 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 | Participants with Health Status 5 at baseline | Rate of COVID-19 disease-related aggravation by Day 60 | 16 Participants |
| LAU-7b Phase 2 | 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 | Participants with Health Status 3 + 4 at baseline | Rate of COVID-19 disease-related aggravation by Day 60 | 11 Participants |
| LAU-7b Phase 2 | 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 | Participants with Health Status 5 at baseline | No aggravation by Day 60 | 25 Participants |
| LAU-7b Phase 2 | 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 | Participants with Health Status 3 + 4 at baseline | No aggravation by Day 60 | 65 Participants |
| LAU-7b Phase 2 | 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 | Overall ITT population | Rate of COVID-19 disease-related aggravation by Day 60 | 27 Participants |
| Placebo Phase 2 | 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 | Participants with Health Status 5 at baseline | No aggravation by Day 60 | 35 Participants |
| Placebo Phase 2 | 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 | Overall ITT population | Rate of COVID-19 disease-related aggravation by Day 60 | 28 Participants |
| Placebo Phase 2 | 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 | Overall ITT population | No aggravation by Day 60 | 87 Participants |
| Placebo Phase 2 | 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 | Participants with Health Status 3 + 4 at baseline | No aggravation by Day 60 | 52 Participants |
| Placebo Phase 2 | 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 | Participants with Health Status 5 at baseline | Rate of COVID-19 disease-related aggravation by Day 60 | 8 Participants |
| Placebo Phase 2 | 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 | Participants with Health Status 3 + 4 at baseline | Rate of COVID-19 disease-related aggravation by Day 60 | 20 Participants |
Comparison: Calculated based on the total number of participants who had the event prior to or with Day 60 assessment available within each groupp-value: 1Fisher Exact
Comparison: Calculated based on the total number of participants with health status 3 + 4 at baseline who had the event prior to or with Day 60 assessment available within each group.p-value: 0.068Fisher Exact
Comparison: Calculated based on the total number of participants with health status 5 at baseline who had the event prior to or with Day 60 assessment available within each group.p-value: 0.0534Fisher Exact
Secondary
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
Population: ITT population, in this portion of study, participants with Health Status 3, 4 or 5 were enrolled.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LAU-7b Phase 2 | 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). | Overall ITT population, 75% percentile value | 14 days |
| LAU-7b Phase 2 | 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). | Participants with Health Status 5 at baseline, 75% percentile value | 21 days |
| LAU-7b Phase 2 | 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). | Participants with Health Status 3 + 4 at baseline, 75% percentile value | 8 days |
| Placebo Phase 2 | 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). | Overall ITT population, 75% percentile value | 13 days |
| Placebo Phase 2 | 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). | Participants with Health Status 3 + 4 at baseline, 75% percentile value | 10 days |
| Placebo Phase 2 | 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). | Participants with Health Status 5 at baseline, 75% percentile value | 15 days |
Comparison: If health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60. Overall ITT population.p-value: 0.9358Log Rank
Comparison: If health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60. Participants with Health Status 3 + 4 at baseline.p-value: 0.63Log Rank
Comparison: If health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60. Participants with Health Status 5 at baseline.p-value: 0.655Log Rank
Secondary
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
Population: ITT population; in this portion of study, all except one (Health Status of 5) had a Health Status of 3 or 4 at baseline, the participant with Health Status of 5 is grouped with the other participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LAU-7b Phase 2 | For Phase 3 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60 | 5.81 days | Standard Deviation 6.95 |
| Placebo Phase 2 | For Phase 3 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60 | 6.77 days | Standard Deviation 6.41 |
Comparison: Overall ITT population. The Kolmogorov-Smirnov test and visual check indicated the normality assumption was rejected, and two-sided Wilcoxon rank sum test was used to obtain the P-valuep-value: 0.4787Wilcoxon (Mann-Whitney)
Secondary
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
Population: ITT population; in this study portion all participants except one (Health Status of 5) had a Health Status of 3 or 4 at baseline, the participant with Health Status of 5 is grouped with the other participants. This endpoint was not statistically analyzed for Phase 3, terminated early for futility.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LAU-7b Phase 2 | 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 | Rate of all-cause death by Day 29 | 0 Participants |
| LAU-7b Phase 2 | 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 | All other Health Status including missing data | 57 Participants |
| Placebo Phase 2 | 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 | Rate of all-cause death by Day 29 | 1 Participants |
| Placebo Phase 2 | 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 | All other Health Status including missing data | 61 Participants |
Secondary
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
Population: ITT population; in this portion of study, all except one (Health Status of 5) had a Health Status of 3 or 4 at baseline, the participant with Health Status of 5 is grouped with the other participants. This endpoint was not statistically analyzed for Phase 3, terminated early for futility.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LAU-7b Phase 2 | 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 | Rate of all-cause death by Day 60 | 3 Participants |
| LAU-7b Phase 2 | 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 | All other Health Status including missing data | 54 Participants |
| Placebo Phase 2 | 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 | Rate of all-cause death by Day 60 | 1 Participants |
| Placebo Phase 2 | 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 | All other Health Status including missing data | 61 Participants |
Secondary
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
Population: ITT population; in this portion of study, all except one (Health Status of 5) had a Health Status of 3 or 4 at baseline, the participant with Health Status of 5 is grouped with the other participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LAU-7b Phase 2 | 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 | Rate of COVID-19 disease-related aggravation by Day 60 | 7 Participants |
| LAU-7b Phase 2 | 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 | No aggravation by Day 60 | 50 Participants |
| Placebo Phase 2 | 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 | Rate of COVID-19 disease-related aggravation by Day 60 | 9 Participants |
| Placebo Phase 2 | 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 | No aggravation by Day 60 | 53 Participants |
Comparison: Calculated based on the total number of participants who had the event prior to or with Day 60 assessment available within each groupp-value: 0.7923Fisher Exact
Secondary
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
Population: ITT population; in this portion of study, all except one (Health Status of 5) had a Health Status of 3 or 4 at baseline, the participant with Health Status of 5 is grouped with the other participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| LAU-7b Phase 2 | 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 days |
| Placebo Phase 2 | 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 days |
Comparison: If health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60. Overall ITT population.p-value: 0.9101Log Rank
Secondary
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
Population: ITT population; this endpoint was not statistically analyzed for Phase 3, terminated early for futility.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAU-7b Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 5 | 9 Participants |
| LAU-7b Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 2 | 5 Participants |
| LAU-7b Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 3 | 33 Participants |
| LAU-7b Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 4 | 48 Participants |
| LAU-7b Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 1 | 2 Participants |
| LAU-7b Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 6 | 7 Participants |
| LAU-7b Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 7 | 1 Participants |
| LAU-7b Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Missing Health Status data | 12 Participants |
| LAU-7b Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 1 | 44 Participants |
| LAU-7b Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 2 | 35 Participants |
| LAU-7b Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 3 | 2 Participants |
| LAU-7b Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 4 | 2 Participants |
| LAU-7b Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 5 | 2 Participants |
| LAU-7b Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 6 | 4 Participants |
| LAU-7b Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 7 | 0 Participants |
| LAU-7b Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Missing Health Status data | 28 Participants |
| Placebo Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 1 | 1 Participants |
| Placebo Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 3 | 32 Participants |
| Placebo Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 1 | 42 Participants |
| Placebo Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 2 | 5 Participants |
| Placebo Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 5 | 4 Participants |
| Placebo Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 2 | 42 Participants |
| Placebo Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 6 | 7 Participants |
| Placebo Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 6 | 1 Participants |
| Placebo Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 7 | 1 Participants |
| Placebo Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 3 | 0 Participants |
| Placebo Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 4 | 57 Participants |
| Placebo Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Missing Health Status data | 27 Participants |
| Placebo Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 4 | 3 Participants |
| Placebo Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 7 | 0 Participants |
| Placebo Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Missing Health Status data | 8 Participants |
| Placebo Phase 2 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 5 | 0 Participants |
| LAU-7b Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Missing Health Status data | 8 Participants |
| LAU-7b Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 1 | 0 Participants |
| LAU-7b Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 5 | 0 Participants |
| LAU-7b Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 2 | 2 Participants |
| LAU-7b Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Missing Health Status data | 2 Participants |
| LAU-7b Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 3 | 20 Participants |
| LAU-7b Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 4 | 33 Participants |
| LAU-7b Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 6 | 0 Participants |
| LAU-7b Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 3 | 2 Participants |
| LAU-7b Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 7 | 0 Participants |
| LAU-7b Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 6 | 0 Participants |
| LAU-7b Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 2 | 11 Participants |
| LAU-7b Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 1 | 36 Participants |
| LAU-7b Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 7 | 0 Participants |
| LAU-7b Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 4 | 0 Participants |
| LAU-7b Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 5 | 0 Participants |
| Placebo Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 4 | 26 Participants |
| Placebo Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 5 | 3 Participants |
| Placebo Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 6 | 0 Participants |
| Placebo Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 6 | 0 Participants |
| Placebo Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 7 | 0 Participants |
| Placebo Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Missing Health Status data | 1 Participants |
| Placebo Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 1 | 30 Participants |
| Placebo Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 7 | 0 Participants |
| Placebo Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 2 | 20 Participants |
| Placebo Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 5 | 0 Participants |
| Placebo Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 3 | 1 Participants |
| Placebo Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Health Status = 4 | 4 Participants |
| Placebo Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 1 | 0 Participants |
| Placebo Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 2 | 4 Participants |
| Placebo Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 29 | Missing Health Status data | 7 Participants |
| Placebo Phase 3 | Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups. | Health Status on Day 14 | Health Status = 3 | 28 Participants |
Comparison: ITT population, Day 14. The proportional odds assumption of the ordinal logistic regression was not met (P-value of Score test = 0.0180) and a Wilcoxon two sample test was performed.p-value: 0.5459Wilcoxon (Mann-Whitney)
Comparison: ITT population, Day 29. The proportional odds assumption of the ordinal logistic regression was not met (P-value \<.0001) and a Wilcoxon two sample test was performed.p-value: 0.6229Wilcoxon (Mann-Whitney)
Secondary
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
Population: ITT population with Day 29 health status/survival data (no imputation); this is a secondary endpoint for Phase 3, terminated early for futility.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LAU-7b Phase 2 | Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively) | 48 Participants |
| Placebo Phase 2 | Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively) | 55 Participants |
p-value: 1Fisher Exact
Secondary
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
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LAU-7b Phase 2 | The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | Baseline | 0.544 score on a scale | Standard Deviation 0.346 |
| LAU-7b Phase 2 | The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | Day 14 or end of hospitalization | 0.747 score on a scale | Standard Deviation 0.274 |
| LAU-7b Phase 2 | The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | Day 29 | 0.838 score on a scale | Standard Deviation 0.238 |
| LAU-7b Phase 2 | The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | Day 45 | 0.871 score on a scale | Standard Deviation 0.25 |
| LAU-7b Phase 2 | The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | Day 60 | 0.888 score on a scale | Standard Deviation 0.195 |
| Placebo Phase 2 | The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | Day 14 or end of hospitalization | 0.783 score on a scale | Standard Deviation 0.218 |
| Placebo Phase 2 | The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | Day 45 | 0.912 score on a scale | Standard Deviation 0.139 |
| Placebo Phase 2 | The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | Day 29 | 0.853 score on a scale | Standard Deviation 0.185 |
| Placebo Phase 2 | The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | Baseline | 0.599 score on a scale | Standard Deviation 0.318 |
| Placebo Phase 2 | The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | Day 60 | 0.920 score on a scale | Standard Deviation 0.127 |
| LAU-7b Phase 3 | The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | Day 60 | 0.830 score on a scale | Standard Deviation 0.18 |
| LAU-7b Phase 3 | The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | Day 29 | 0.819 score on a scale | Standard Deviation 0.263 |
| LAU-7b Phase 3 | The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | Day 45 | 0.824 score on a scale | Standard Deviation 0.216 |
| LAU-7b Phase 3 | The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | Day 14 or end of hospitalization | 0.745 score on a scale | Standard Deviation 0.309 |
| LAU-7b Phase 3 | The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | Baseline | 0.597 score on a scale | Standard Deviation 0.308 |
| Placebo Phase 3 | The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | Day 29 | 0.754 score on a scale | Standard Deviation 0.264 |
| Placebo Phase 3 | The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | Day 60 | 0.774 score on a scale | Standard Deviation 0.292 |
| Placebo Phase 3 | The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | Day 14 or end of hospitalization | 0.660 score on a scale | Standard Deviation 0.324 |
| Placebo Phase 3 | The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | Day 45 | 0.745 score on a scale | Standard Deviation 0.308 |
| Placebo Phase 3 | The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey | Baseline | 0.517 score on a scale | Standard Deviation 0.324 |
Comparison: The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 14 or end of hospitalization data.p-value: 0.474695% CI: [-0.07, 0.03]Mixed Models Analysis
Comparison: The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 29.p-value: 0.744595% CI: [-0.06, 0.05]Mixed Models Analysis
Comparison: The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 45.p-value: 0.710595% CI: [-0.07, 0.05]Mixed Models Analysis
Comparison: The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 60.p-value: 0.642495% CI: [-0.07, 0.04]Mixed Models Analysis
Comparison: The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 14 or end of hospitalization data.p-value: 0.278995% CI: [-0.04, 0.14]Mixed Models Analysis
Comparison: The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 29p-value: 0.288495% CI: [-0.04, 0.14]Mixed Models Analysis
Comparison: The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 45p-value: 0.205895% CI: [-0.03, 0.15]Mixed Models Analysis
Comparison: The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 60p-value: 0.51695% CI: [-0.06, 0.12]Mixed Models Analysis
Secondary
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
Population: Safety population = ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LAU-7b Phase 2 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Headache | 5 participants |
| LAU-7b Phase 2 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Cough | 0 participants |
| LAU-7b Phase 2 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Nausea | 4 participants |
| LAU-7b Phase 2 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Constipation | 10 participants |
| LAU-7b Phase 2 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Vision blurred | 18 participants |
| LAU-7b Phase 2 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Dry skin | 21 participants |
| LAU-7b Phase 2 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Insomnia | 7 participants |
| LAU-7b Phase 2 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Dyspnea | 8 participants |
| LAU-7b Phase 2 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Diarrhea | 14 participants |
| Placebo Phase 2 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Headache | 12 participants |
| Placebo Phase 2 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Dry skin | 17 participants |
| Placebo Phase 2 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Vision blurred | 20 participants |
| Placebo Phase 2 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Diarrhea | 7 participants |
| Placebo Phase 2 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Constipation | 12 participants |
| Placebo Phase 2 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Nausea | 7 participants |
| Placebo Phase 2 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Cough | 0 participants |
| Placebo Phase 2 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Dyspnea | 7 participants |
| Placebo Phase 2 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Insomnia | 4 participants |
| LAU-7b Phase 3 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Nausea | 6 participants |
| LAU-7b Phase 3 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Diarrhea | 3 participants |
| LAU-7b Phase 3 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Cough | 6 participants |
| LAU-7b Phase 3 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Constipation | 2 participants |
| LAU-7b Phase 3 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Dyspnea | 8 participants |
| LAU-7b Phase 3 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Vision blurred | 5 participants |
| LAU-7b Phase 3 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Dry skin | 7 participants |
| LAU-7b Phase 3 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Headache | 2 participants |
| LAU-7b Phase 3 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Insomnia | 4 participants |
| Placebo Phase 3 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Dry skin | 12 participants |
| Placebo Phase 3 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Nausea | 8 participants |
| Placebo Phase 3 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Headache | 5 participants |
| Placebo Phase 3 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Insomnia | 7 participants |
| Placebo Phase 3 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Dyspnea | 6 participants |
| Placebo Phase 3 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Cough | 7 participants |
| Placebo Phase 3 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Diarrhea | 10 participants |
| Placebo Phase 3 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Constipation | 4 participants |
| Placebo Phase 3 | The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group | Vision blurred | 5 participants |
Secondary
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
Population: Safety population = ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LAU-7b Phase 2 | The Safety of LAU-7b Therapy, Overview. | Participants with suspected unexpected serious adverse reaction (SUSAR) | 0 participants |
| LAU-7b Phase 2 | The Safety of LAU-7b Therapy, Overview. | Participants with at least possibly-related serious TEAEs | 0 participants |
| LAU-7b Phase 2 | The Safety of LAU-7b Therapy, Overview. | Participants with AE related to COVID-19 | 62 participants |
| LAU-7b Phase 2 | The Safety of LAU-7b Therapy, Overview. | Participants with serious TEAEs | 23 participants |
| LAU-7b Phase 2 | The Safety of LAU-7b Therapy, Overview. | Participants with TEAEs leading to treatment discontinuation | 22 participants |
| LAU-7b Phase 2 | The Safety of LAU-7b Therapy, Overview. | Participants with TEAEs with fatal outcome | 13 participants |
| LAU-7b Phase 2 | The Safety of LAU-7b Therapy, Overview. | Participants with TEAEs | 97 participants |
| Placebo Phase 2 | The Safety of LAU-7b Therapy, Overview. | Participants with TEAEs with fatal outcome | 11 participants |
| Placebo Phase 2 | The Safety of LAU-7b Therapy, Overview. | Participants with TEAEs leading to treatment discontinuation | 18 participants |
| Placebo Phase 2 | The Safety of LAU-7b Therapy, Overview. | Participants with serious TEAEs | 22 participants |
| Placebo Phase 2 | The Safety of LAU-7b Therapy, Overview. | Participants with at least possibly-related serious TEAEs | 0 participants |
| Placebo Phase 2 | The Safety of LAU-7b Therapy, Overview. | Participants with TEAEs | 94 participants |
| Placebo Phase 2 | The Safety of LAU-7b Therapy, Overview. | Participants with AE related to COVID-19 | 62 participants |
| Placebo Phase 2 | The Safety of LAU-7b Therapy, Overview. | Participants with suspected unexpected serious adverse reaction (SUSAR) | 0 participants |
| LAU-7b Phase 3 | The Safety of LAU-7b Therapy, Overview. | Participants with TEAEs | 45 participants |
| LAU-7b Phase 3 | The Safety of LAU-7b Therapy, Overview. | Participants with serious TEAEs | 12 participants |
| LAU-7b Phase 3 | The Safety of LAU-7b Therapy, Overview. | Participants with at least possibly-related serious TEAEs | 0 participants |
| LAU-7b Phase 3 | The Safety of LAU-7b Therapy, Overview. | Participants with TEAEs with fatal outcome | 3 participants |
| LAU-7b Phase 3 | The Safety of LAU-7b Therapy, Overview. | Participants with TEAEs leading to treatment discontinuation | 1 participants |
| LAU-7b Phase 3 | The Safety of LAU-7b Therapy, Overview. | Participants with AE related to COVID-19 | 28 participants |
| LAU-7b Phase 3 | The Safety of LAU-7b Therapy, Overview. | Participants with suspected unexpected serious adverse reaction (SUSAR) | 0 participants |
| Placebo Phase 3 | The Safety of LAU-7b Therapy, Overview. | Participants with at least possibly-related serious TEAEs | 0 participants |
| Placebo Phase 3 | The Safety of LAU-7b Therapy, Overview. | Participants with suspected unexpected serious adverse reaction (SUSAR) | 0 participants |
| Placebo Phase 3 | The Safety of LAU-7b Therapy, Overview. | Participants with AE related to COVID-19 | 28 participants |
| Placebo Phase 3 | The Safety of LAU-7b Therapy, Overview. | Participants with serious TEAEs | 13 participants |
| Placebo Phase 3 | The Safety of LAU-7b Therapy, Overview. | Participants with TEAEs | 54 participants |
| Placebo Phase 3 | The Safety of LAU-7b Therapy, Overview. | Participants with TEAEs leading to treatment discontinuation | 4 participants |
| Placebo Phase 3 | The Safety of LAU-7b Therapy, Overview. | Participants with TEAEs with fatal outcome | 1 participants |