Study of LAU-7b for the Treatment of Coronavirus Disease... | NCT04417257

NCT04417257

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LAU-7b	Experimental	Active drug as LAU-7b capsules	Drug: LAU-7b
Placebo	Placebo Comparator	Placebo oral capsule (as inactive capsules identical to active arm)	Drug: Placebo oral capsule

Name	Type	Description	Arm Group Labels	Other Names
LAU-7b	Drug	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.	LAU-7b

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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. Not hospitalized, no limitations on activities Not hospitalized, limitation on activities Hospitalized, not requiring supplemental oxygen Hospitalized, requiring supplemental oxygen Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation Death	On Day 29
Primary Outcome for Phase 3: Proportion of Participants Requiring Mechanical Ventilation (Includes Extra-corporeal Membrane Oxygenation - ECMO) AND/OR Deceased (All Causes) by Day 60 (Ordinal Scale Scores 1-4, Inclusively)	This will be assessed through health status scoring using the WHO 7-point Ordinal Scale, a higher score is worse than a low score. Not hospitalized, no limitations on activities Not hospitalized, limitation on activities Hospitalized, not requiring supplemental oxygen Hospitalized, requiring supplemental oxygen Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation Death	By Day 60

Secondary Outcomes

Measure	Description	Time Frame
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.	From baseline to Day 60
The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)
Participant was 18 years and older, of either gender
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
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]
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
[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"]
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
Participant had the ability to understand and give informed consent, which could have been verbal with a witness, according to local requirements
Participant was deemed capable of adequate compliance including attending scheduled visits for the duration of the study
Participant was able to swallow the study drug capsules

Exclusion Criteria:

Pregnancy or breastfeeding
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]
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
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
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)]
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
[Extension Phase 3 study only: Subject expected to be transferred to ICU or die in the next 24 hours]

Contacts/Locations Module

Name	Affiliation	Role
Jean-Marie Houle, PhD	Laurent Pharmaceuticals Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Chandler Regional Medical Center / Mercy Gilbert Medical Center		Chandler	Arizona	85224	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	LAU-7b	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, 300 mg per day for the first 3 days, followed by 200 mg per day
FG001	Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol: Pilot Phase 2 Protocol	Oct 18, 2020

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

FG000117 subjectsModified Intention To Treat (ITT), subjects must have received at least one dose of study treatment

FG001115 subjectsModified ITT, subjects must have received at least one dose of study treatment

The Pilot Phase 2 and the Phase 3 extensions are distinct, sequential portions with different subjects.

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	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.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00057.5± 13.5 BG00156.7± 12.4 BG00268.1± 12.97 BG003

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
18 to 44 years	BG00022 BG00122 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00046 BG00145 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00010 BG00117 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0011 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Canada

Title	Measurements
	BG00037 BG00135 BG002

Health Status of the Patient on the 7-point Ordinal Scale

The main efficacy variable is the 7-point patient health status ordinal scale proposed by the World Health Organization (WHO) for Coronavirus Disease 2019 (COVID-19) clinical trials. The scale is as follows:

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
Death

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Health Status at baseline = 3	BG00017 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation
Death

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)

Posted

Count of Participants

Participants

On Day 29

ID	Title	Description
OG000	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, 300 mg per day for the first 3 days, followed by 200 mg per day
OG001	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, 3 capsules per day for the first 3 days, and 2 capsules per day for the following days.

Units	Counts
Participants	OG000117 OG001115

Title

Denominators

Categories

ITT population, alive and free of respiratory failure. Missing data as failure.

- ParticipantsOG000117
- ParticipantsOG001115

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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.	Fisher Exact		0.7377	one-sided (right tailed)	Mean Difference (Final Values)	-2.9			2-Sided	95	-15	9			A positive difference favours LAU-7b, a negative difference favours placebo.		Superiority

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.

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation
Death

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)

Posted

Count of Participants

Participants

By Day 60

ID	Title	Description
OG000	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, 300 mg per day for the first 3 days, followed by 200 mg per day
OG001	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, 3 capsules per day for the first 3 days, and 2 capsules per day for the following days.

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.

Safety population = ITT population

Posted

Number

participants

From baseline to Day 60

ID	Title	Description
OG000	LAU-7b Phase 2	Active drug as LAU-7b capsules 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, 300 mg per day for the first 3 days, followed by 200 mg per day
OG001	Placebo Phase 2	Placebo oral capsule (as inactive capsules identical to active arm) 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, 3 capsules per day for the first 3 days, and 2 capsules per day for the following days.
OG002	LAU-7b Phase 3	Active drug as LAU-7b capsules 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, 300 mg per day for the first 3 days, followed by 200 mg per day

Secondary

The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group

Safety population = ITT

Posted

Number

participants

From baseline to Day 60

ID	Title	Description
OG000	LAU-7b Phase 2	Active drug as LAU-7b capsules 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, 300 mg per day for the first 3 days, followed by 200 mg per day
OG001	Placebo Phase 2	Placebo oral capsule (as inactive capsules identical to active arm) 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, 3 capsules per day for the first 3 days, and 2 capsules per day for the following days.
OG002	LAU-7b Phase 3	Active drug as LAU-7b capsules 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, 300 mg per day for the first 3 days, followed by 200 mg per day

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.

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation
Death

ITT population; this endpoint was not statistically analyzed for Phase 3, terminated early for futility.

Posted

Count of Participants

Participants

On Days 14 and 29

ID	Title	Description
OG000	LAU-7b Phase 2	Active drug as LAU-7b capsules LAU-7b administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG001	Placebo Phase2	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG002	LAU-7b Phase 3

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.

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation
Death

ITT population; In this portion of study, participants with Health Status 3,4 and 5 were enrolled.

Posted

Count of Participants

Participants

On Day 29

ID	Title	Description
OG000	LAU-7b Phase 2	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG001	Placebo Phase 2	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.

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.

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation
Death

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.

Posted

Count of Participants

Participants

On Day 29

ID	Title	Description
OG000	LAU-7b Phase 3	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG001	Placebo Phase 3	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.

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.

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation
Death

ITT population; in this portion of study, participants with Health Status 3,4 and 5 were enrolled.

Posted

Count of Participants

Participants

On Day 60

ID	Title	Description
OG000	LAU-7b Phase 2	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG001	Placebo Phase 2	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.

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.

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation
Death

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.

Posted

Count of Participants

Participants

On Day 60

ID	Title	Description
OG000	LAU-7b Phase 3	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG001	Placebo Phase 3	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.

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.

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation
Death

ITT population with Day 29 health status/survival data (no imputation); this is a secondary endpoint for Phase 3, terminated early for futility.

Posted

Count of Participants

Participants

Day 29

ID	Title	Description
OG000	LAU-7b Phase 3	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG001	Placebo Phase 3	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.

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.

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation
Death

ITT population; in this portion of study, participants with Health Status of 3, 4 and 5 were enrolled.

Posted

Count of Participants

Participants

From baseline to Day 60

ID	Title	Description
OG000	LAU-7b Phase 2	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG001	Placebo Phase 2	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.

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.

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation
Death

Posted

Count of Participants

Participants

From baseline to Day 60

ID	Title	Description
OG000	LAU-7b Phase 3	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG001	Placebo Phase 3	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.

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.

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation
Death

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.

Posted

Count of Participants

Participants

From baseline to Day 60

ID	Title	Description
OG000	LAU-7b Phase 2	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG001	Placebo Phase 2	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.

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.

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation
Death

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.

Posted

Count of Participants

Participants

From baseline to Day 60

ID	Title	Description
OG000	LAU-7b Phase 2	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG001	Placebo Phase 2	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.

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.

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation
Death

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.

Posted

Count of Participants

Participants

From baseline to Day 60

ID	Title	Description
OG000	LAU-7b Phase 2	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG001	Placebo Phase 2	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.

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.

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation
Death

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.

Posted

Mean

95% Confidence Interval

days

From baseline to Day 60

ID	Title	Description
OG000	LAU-7b Phase 2	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG001	Placebo Phase 2	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.

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.

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation
Death

ITT population, in this portion of study, participants with Health Status 3, 4 or 5 were enrolled.

Posted

Mean

95% Confidence Interval

days

From baseline to Day 60

ID	Title	Description
OG000	LAU-7b Phase 2	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG001	Placebo Phase 2	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.

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.

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation
Death

Posted

Mean

95% Confidence Interval

days

From baseline to Day 60

ID	Title	Description
OG000	LAU-7b Phase 3	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG001	Placebo Phase 3	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 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.

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation
Death

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.

Posted

Mean

95% Confidence Interval

days

From baseline to Day 60

ID	Title	Description
OG000	LAU-7b Phase 2	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG001	Placebo Phase 2	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.

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.

Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities
Hospitalized, not requiring supplemental oxygen
Hospitalized, requiring supplemental oxygen
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation
Death

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.

Posted

Mean

95% Confidence Interval

days

From baseline to Day 60

ID	Title	Description
OG000	LAU-7b Phase 2	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG001	Placebo Phase 2	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 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.

ITT population, in this portion of study, participants with Health Status 3, 4 or 5 were enrolled.

Posted

Mean

Standard Deviation

days

From baseline to Day 60

ID	Title	Description
OG000	LAU-7b Phase 2	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG001	Placebo Phase 2	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.

Units	Counts
Participants	OG000

Secondary

For Phase 3 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60

Posted

Mean

Standard Deviation

days

From baseline to Day 60

ID	Title	Description
OG000	LAU-7b Phase 3	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG001	Placebo Phase 3	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.

Units	Counts
Participants

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.

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

Posted

Number

participants

Until discharge of participants, up to Day 60

ID	Title	Description
OG000	LAU-7b Phase 2	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG001	Placebo Phase 2	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.

Units	Counts

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.

ITT population

Posted

Mean

Standard Deviation

score on a scale

On Days 1, 14, 29, 45 and 60

ID	Title	Description
OG000	LAU-7b Phase 2	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG001	Placebo Phase 2	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
OG002	LAU-7b Phase 3	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	LAU-7b Phase 2	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 300 mg per day for the first 3 days, followed by 200 mg per day	14	117	23	117	97	117
EG001	Placebo Phase 2	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 3 capsules per day for the first 3 days, and 2 capsules per day for the following days.	11	115	22	115	94	115
EG002	LAU-7b Phase 3	Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 300 mg per day for the first 3 days, followed by 200 mg per day	3	57	12	57	45	57
EG003	Placebo Phase 3	Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 3 capsules per day for the first 3 days, and 2 capsules per day for the following days.	1	62	13	62	54	62

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Idiopathic neutropenia	Blood and lymphatic system disorders	medDRA 23.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG0030 affected62 at risk
Atrial flutter	Cardiac disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0011 events1 affected115 at risk EG0020 affected57 at risk EG003
Atrioventricular block complete	Cardiac disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0021 events1 affected57 at risk EG003
Cardiac arrest	Cardiac disorders	medDRA 23.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0010 affected115 at risk EG0021 events1 affected57 at risk EG003
Cardiac failure	Cardiac disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	medDRA 23.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003
Cardiogenic shock	Cardiac disorders	medDRA 23.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003
Cor pulmonale acute	Cardiac disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003
Coronary artery disease	Cardiac disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0011 events1 affected115 at risk EG0020 affected57 at risk EG003
Pulseless electrical activity	Cardiac disorders	medDRA 23.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003
Ventricular tachycardia	Cardiac disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0021 events1 affected57 at risk EG003
Duodenal ulcer haemorrhage	Gastrointestinal disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003
Haematochezia	Gastrointestinal disorders	medDRA 23.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003
Obstruction gastric	Gastrointestinal disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003
Sudden death	General disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0021 events1 affected57 at risk EG003
Anaphylactic reaction	Immune system disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0021 events1 affected57 at risk EG003
COVID-19 pneumonia	Infections and infestations	medDRA 23.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0011 events1 affected115 at risk EG0020 affected57 at risk EG003
Pneumonia	Infections and infestations	medDRA 23.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0015 events5 affected115 at risk EG0021 events1 affected57 at risk EG003
Sepsis	Infections and infestations	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0021 events1 affected57 at risk EG003
Septic shock	Infections and infestations	medDRA 23.0	Systematic Assessment	EG0002 events2 affected117 at risk EG0011 events1 affected115 at risk EG0020 affected57 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003
Subdural hematoma	Injury, poisoning and procedural complications	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0021 events1 affected57 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0021 events1 affected57 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0021 events1 affected57 at risk EG003
Aphasia	Nervous system disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003
Cerebellar infarction	Nervous system disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003
Cerebrovascular accident	Nervous system disorders	medDRA 23.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0011 events1 affected115 at risk EG0020 affected57 at risk EG003
Encephalopathy	Nervous system disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0021 events1 affected57 at risk EG003
Ischaemic cerebral infarction	Nervous system disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0011 events1 affected115 at risk EG0020 affected57 at risk EG003
Anxiety	Psychiatric disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0011 events1 affected115 at risk EG0020 affected57 at risk EG003
Completed suicide	Psychiatric disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003
Delirium	Psychiatric disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0021 events1 affected57 at risk EG003
Paranoia	Psychiatric disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0021 events1 affected57 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	medDRA 23.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0011 events1 affected115 at risk EG0020 affected57 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	medDRA 23.0	Systematic Assessment	EG0005 events5 affected117 at risk EG0012 events2 affected115 at risk EG0021 events1 affected57 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0021 events1 affected57 at risk EG003
Asthma-chronic obstructive pulmonary disease overlap syndrome	Respiratory, thoracic and mediastinal disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0011 events1 affected115 at risk EG0020 affected57 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0022 events2 affected57 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	medDRA 23.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0011 events1 affected115 at risk EG0020 affected57 at risk EG003
Organizing pneumonia	Respiratory, thoracic and mediastinal disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	medDRA 23.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	medDRA 23.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	medDRA 23.0	Systematic Assessment	EG0009 events9 affected117 at risk EG0019 events9 affected115 at risk EG0020 affected57 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0011 events1 affected115 at risk EG0020 affected57 at risk EG003
Acute kidney injury	Renal and urinary disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0011 events1 affected115 at risk EG0020 affected57 at risk EG003
Nephrolithiasis	Renal and urinary disorders	medDRA 23.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003
Renal failure	Renal and urinary disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0011 events1 affected115 at risk EG0020 affected57 at risk EG003
Arterial haemorrhage	Vascular disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003
Deep vein thrombosis	Vascular disorders	medDRA 23.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0011 events1 affected115 at risk EG0020 affected57 at risk EG003
Haemorrhage	Vascular disorders	medDRA 23.0	Systematic Assessment	EG0000 affected117 at risk EG0010 affected115 at risk EG0020 affected57 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vision blurred	Eye disorders	medDRA 23.0	Systematic Assessment	EG00018 events18 affected117 at risk EG00120 events20 affected115 at risk EG0025 events5 affected57 at risk EG0036 events5 affected62 at risk
Constipation	Gastrointestinal disorders	medDRA 23.0	Systematic Assessment	EG00010 events10 affected117 at risk EG00113 events12 affected115 at risk EG0022 events2 affected57 at risk EG003
Diarrhoea	Gastrointestinal disorders	medDRA 23.0	Systematic Assessment	EG00014 events14 affected117 at risk EG0017 events7 affected115 at risk EG0023 events3 affected57 at risk EG003
Nausea	Gastrointestinal disorders	medDRA 23.0	Systematic Assessment	EG0004 events4 affected117 at risk EG0017 events7 affected115 at risk EG0026 events6 affected57 at risk EG003
Fatigue	General disorders	medDRA 23.0	Systematic Assessment	EG0002 events2 affected117 at risk EG0016 events6 affected115 at risk EG0025 events5 affected57 at risk EG003
Pyrexia	General disorders	medDRA 23.0	Systematic Assessment	EG0005 events5 affected117 at risk EG0013 events3 affected115 at risk EG0022 events2 affected57 at risk EG003
Transaminases increased	Investigations	medDRA 23.0	Systematic Assessment	EG0007 events7 affected117 at risk EG0013 events3 affected115 at risk EG0020 affected57 at risk EG003
Hyperglicaemia	Metabolism and nutrition disorders	medDRA 23.0	Systematic Assessment	EG0002 events2 affected117 at risk EG0016 events6 affected115 at risk EG0021 events1 affected57 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	medDRA 23.0	Systematic Assessment	EG0003 events3 affected117 at risk EG0015 events5 affected115 at risk EG0024 events4 affected57 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	medDRA 23.0	Systematic Assessment	EG0002 events2 affected117 at risk EG0010 affected115 at risk EG0023 events3 affected57 at risk EG003
Dizziness	Nervous system disorders	medDRA 23.0	Systematic Assessment	EG0004 events3 affected117 at risk EG0014 events4 affected115 at risk EG0023 events3 affected57 at risk EG003
Headache	Nervous system disorders	medDRA 23.0	Systematic Assessment	EG0005 events5 affected117 at risk EG00112 events12 affected115 at risk EG0022 events2 affected57 at risk EG003
Taste disorder	Nervous system disorders	medDRA 23.0	Systematic Assessment	EG0001 events1 affected117 at risk EG0012 events2 affected115 at risk EG0024 events4 affected57 at risk EG003
Insomnia	Psychiatric disorders	medDRA 23.0	Systematic Assessment	EG0007 events7 affected117 at risk EG0014 events4 affected115 at risk EG0024 events4 affected57 at risk EG003
Acute kidney injury	Renal and urinary disorders	medDRA 23.0	Systematic Assessment	EG0009 events9 affected117 at risk EG0013 events3 affected115 at risk EG0020 affected57 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	medDRA 23.0	Systematic Assessment	EG0002 events2 affected117 at risk EG0015 events5 affected115 at risk EG0026 events6 affected57 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	medDRA 23.0	Systematic Assessment	EG0008 events8 affected117 at risk EG0017 events6 affected115 at risk EG0028 events8 affected57 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	medDRA 23.0	Systematic Assessment	EG0003 events3 affected117 at risk EG0014 events4 affected115 at risk EG0023 events3 affected57 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	medDRA 23.0	Systematic Assessment	EG00022 events21 affected117 at risk EG00117 events17 affected115 at risk EG0027 events7 affected57 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	medDRA 23.0	Systematic Assessment	EG0002 events2 affected117 at risk EG0013 events3 affected115 at risk EG0023 events3 affected57 at risk EG003
Hypotension	Vascular disorders	medDRA 23.0	Systematic Assessment	EG0005 events5 affected117 at risk EG0019 events9 affected115 at risk EG0022 events2 affected57 at risk EG003

The Pilot Phase 2 was conducted prior to the Omicron variants and completed normally. Participants with Health Status 3 + 4 grouped together were further studied in a Phase 3 extension, conducted with Omicron variants and vaccination. The Phase 3 was terminated early for futility due to lack of aggravation events (primary efficacy endpoint). The Phase 3 SAP pre-specified the efficacy analyses performed under such a scenario.

Certain Agreements

First MCP Posted Date

ID	Term
D007249	Inflammation

ID	Term
D017313	Fenretinide

Ancestor Terms

ID	Term
D012176	Retinoids
D002338	Carotenoids
D011090	Polyenes
D000475	Alkenes
D006839	Hydrocarbons, Acyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D053138	Cyclohexenes
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D013729	Terpenes
D010860	Pigments, Biological
D001685	Biological Factors

Active drug as LAU-7b capsules

LAU-7b administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.

Units	Counts
Participants	OG00057 OG00162

Units	Counts
Participants	OG000117 OG001115

Units	Counts
Participants	OG000117 OG001115

Units	Counts
Participants	OG000117 OG001115

Units	Counts
Participants	OG000117 OG001115

Title	Measurements
	OG0000.838± 0.238 OG0010.853± 0.185 OG0020.819± 0.263 OG0030.754± 0.264

Title	Measurements
	OG0000.871± 0.250 OG0010.912± 0.139 OG0020.824± 0.216 OG0030.745± 0.308

Title	Measurements
	OG0000.888± 0.195 OG0010.920± 0.127 OG0020.830± 0.180 OG0030.774± 0.292

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms