Trial Outcomes & Findings for Study of LAU-7b for the Treatment of Coronavirus Disease 2019 (COVID-19) Disease in Adults (NCT NCT04417257)

Last Updated: 2025-11-13

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

351 participants

Primary outcome timeframe

On Day 29

Results posted on

2025-11-13

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Placebo 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.	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
Pilot Phase 2 STARTED	115	117
Pilot Phase 2 COMPLETED	91	89
Pilot Phase 2 NOT COMPLETED	24	28
Phase 3 Extension STARTED	62	57
Phase 3 Extension COMPLETED	56	45
Phase 3 Extension NOT COMPLETED	6	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo 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.	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
Pilot Phase 2 Hepatic impairment	0	1
Pilot Phase 2 Unblinding	0	1
Pilot Phase 2 All other	2	0
Phase 3 Extension Death	1	3
Pilot Phase 2 Adverse Event	0	2
Pilot Phase 2 Death	11	14
Pilot Phase 2 Lost to Follow-up	5	3
Pilot Phase 2 Withdrawal by Subject	6	7
Phase 3 Extension Lost to Follow-up	2	4
Phase 3 Extension Patient withdrawal	2	2
Phase 3 Extension Study terminated by sponsor due to futility criteria reached	1	3

Baseline Characteristics

Study of LAU-7b for the Treatment of Coronavirus Disease 2019 (COVID-19) Disease in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LAU-7b Phase 2 n=117 Participants 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.	Placebo Phase 2 n=115 Participants 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.	LAU-7b Phase 3 n=57 Participants 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.	Placebo Phase 3 n=62 Participants 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.	Total n=351 Participants Total of all reporting groups
Age, Continuous	57.5 years STANDARD_DEVIATION 13.5 • n=10 Participants	56.7 years STANDARD_DEVIATION 12.4 • n=10 Participants	68.1 years STANDARD_DEVIATION 12.97 • n=20 Participants	65.9 years STANDARD_DEVIATION 15.91 • n=45 Participants	61.1 years STANDARD_DEVIATION 15 • n=44 Participants
Age, Customized 18 to 44 years	22 Participants n=10 Participants	22 Participants n=10 Participants	4 Participants n=20 Participants	6 Participants n=45 Participants	54 Participants n=44 Participants
Age, Customized 45 to 69 years	70 Participants n=10 Participants	73 Participants n=10 Participants	18 Participants n=20 Participants	26 Participants n=45 Participants	187 Participants n=44 Participants
Age, Customized 70 years and older	25 Participants n=10 Participants	20 Participants n=10 Participants	35 Participants n=20 Participants	30 Participants n=45 Participants	110 Participants n=44 Participants
Sex: Female, Male Female	46 Participants n=10 Participants	45 Participants n=10 Participants	30 Participants n=20 Participants	28 Participants n=45 Participants	149 Participants n=44 Participants
Sex: Female, Male Male	71 Participants n=10 Participants	70 Participants n=10 Participants	27 Participants n=20 Participants	34 Participants n=45 Participants	202 Participants n=44 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=10 Participants	17 Participants n=10 Participants	4 Participants n=20 Participants	5 Participants n=45 Participants	36 Participants n=44 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	106 Participants n=10 Participants	98 Participants n=10 Participants	51 Participants n=20 Participants	56 Participants n=45 Participants	311 Participants n=44 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants	1 Participants n=45 Participants	4 Participants n=44 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=10 Participants	1 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	2 Participants n=44 Participants
Race (NIH/OMB) Asian	5 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants	3 Participants n=45 Participants	9 Participants n=44 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants	0 Participants n=45 Participants	1 Participants n=44 Participants
Race (NIH/OMB) Black or African American	14 Participants n=10 Participants	19 Participants n=10 Participants	7 Participants n=20 Participants	7 Participants n=45 Participants	47 Participants n=44 Participants
Race (NIH/OMB) White	92 Participants n=10 Participants	86 Participants n=10 Participants	46 Participants n=20 Participants	48 Participants n=45 Participants	272 Participants n=44 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	2 Participants n=45 Participants	2 Participants n=44 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=10 Participants	9 Participants n=10 Participants	2 Participants n=20 Participants	2 Participants n=45 Participants	18 Participants n=44 Participants
Region of Enrollment Canada	37 participants n=10 Participants	35 participants n=10 Participants	2 participants n=20 Participants	2 participants n=45 Participants	76 participants n=44 Participants
Region of Enrollment United States	80 participants n=10 Participants	80 participants n=10 Participants	55 participants n=20 Participants	60 participants n=45 Participants	275 participants n=44 Participants
Health Status of the Patient on the 7-point Ordinal Scale Health Status at baseline = 3	17 Participants n=10 Participants	12 Participants n=10 Participants	19 Participants n=20 Participants	19 Participants n=45 Participants	67 Participants n=44 Participants
Health Status of the Patient on the 7-point Ordinal Scale Health Status at baseline = 4	59 Participants n=10 Participants	60 Participants n=10 Participants	37 Participants n=20 Participants	43 Participants n=45 Participants	199 Participants n=44 Participants
Health Status of the Patient on the 7-point Ordinal Scale Health Status at baseline = 5	41 Participants n=10 Participants	43 Participants n=10 Participants	1 Participants n=20 Participants	0 Participants n=45 Participants	85 Participants n=44 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=117 Participants 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.	Placebo Phase 2 n=115 Participants 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.	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.	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.
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	54 Participants	—	—
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	54 Participants	—	—
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	83 Participants	—	—
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	65 Participants	—	—
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	29 Participants	—	—

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=57 Participants 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.	Placebo Phase 2 n=62 Participants 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.	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.	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.
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	2 Participants	—	—
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	2 Participants	—	—

SECONDARY outcome

Timeframe: From baseline to Day 60

Population: Safety population = ITT population

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.

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=117 Participants 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.	Placebo Phase 2 n=115 Participants 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.	LAU-7b Phase 3 n=57 Participants 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.	Placebo Phase 3 n=62 Participants 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.
The Safety of LAU-7b Therapy, Overview. Participants with suspected unexpected serious adverse reaction (SUSAR)	0 participants	0 participants	0 participants	0 participants
The Safety of LAU-7b Therapy, Overview. Participants with TEAEs leading to treatment discontinuation	22 participants	18 participants	1 participants	4 participants
The Safety of LAU-7b Therapy, Overview. Participants with AE related to COVID-19	62 participants	62 participants	28 participants	28 participants
The Safety of LAU-7b Therapy, Overview. Participants with TEAEs	97 participants	94 participants	45 participants	54 participants
The Safety of LAU-7b Therapy, Overview. Participants with serious TEAEs	23 participants	22 participants	12 participants	13 participants
The Safety of LAU-7b Therapy, Overview. Participants with at least possibly-related serious TEAEs	0 participants	0 participants	0 participants	0 participants
The Safety of LAU-7b Therapy, Overview. Participants with TEAEs with fatal outcome	13 participants	11 participants	3 participants	1 participants

SECONDARY outcome

Timeframe: From baseline to Day 60

Population: Safety population = ITT

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=117 Participants 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.	Placebo Phase 2 n=115 Participants 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.	LAU-7b Phase 3 n=57 Participants 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.	Placebo Phase 3 n=62 Participants 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.
The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group Constipation	10 participants	12 participants	2 participants	4 participants
The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group Dyspnea	8 participants	7 participants	8 participants	6 participants
The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group Insomnia	7 participants	4 participants	4 participants	7 participants
The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group Headache	5 participants	12 participants	2 participants	5 participants
The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group Nausea	4 participants	7 participants	6 participants	8 participants
The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group Cough	0 participants	0 participants	6 participants	7 participants
The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group Dry skin	21 participants	17 participants	7 participants	12 participants
The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group Vision blurred	18 participants	20 participants	5 participants	5 participants
The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group Diarrhea	14 participants	7 participants	3 participants	10 participants

SECONDARY outcome

Timeframe: On Days 14 and 29

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

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

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=117 Participants 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.	Placebo Phase 2 n=115 Participants 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.	LAU-7b Phase 3 n=57 Participants 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.	Placebo Phase 3 n=62 Participants 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.
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	1 Participants	0 Participants	0 Participants
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	1 Participants	0 Participants	0 Participants
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	5 Participants	2 Participants	4 Participants
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	32 Participants	20 Participants	28 Participants
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	57 Participants	33 Participants	26 Participants
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	4 Participants	0 Participants	3 Participants
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	7 Participants	0 Participants	0 Participants
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	1 Participants	0 Participants	0 Participants
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	8 Participants	2 Participants	1 Participants
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	42 Participants	36 Participants	30 Participants
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	42 Participants	11 Participants	20 Participants
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	0 Participants	2 Participants	1 Participants
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	3 Participants	0 Participants	4 Participants
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	0 Participants	0 Participants	0 Participants
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	0 Participants	0 Participants	0 Participants
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	27 Participants	8 Participants	7 Participants

SECONDARY outcome

Timeframe: On Day 29

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

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

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=117 Participants 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.	Placebo Phase 2 n=115 Participants 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.	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.	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.
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	10 Participants	—	—
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	105 Participants	—	—
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	4 Participants	—	—
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	68 Participants	—	—
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	6 Participants	—	—
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	37 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=57 Participants 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.	Placebo Phase 2 n=62 Participants 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.	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.	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.
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	1 Participants	—	—
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	61 Participants	—	—

SECONDARY outcome

Timeframe: On Day 60

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

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

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=117 Participants 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.	Placebo Phase 2 n=115 Participants 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.	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.	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.
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	11 Participants	—	—
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	104 Participants	—	—
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	4 Participants	—	—
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	68 Participants	—	—
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	7 Participants	—	—
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	36 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=57 Participants 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.	Placebo Phase 2 n=62 Participants 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.	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.	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.
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	1 Participants	—	—
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	61 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=49 Participants 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.	Placebo Phase 2 n=56 Participants 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.	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.	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.
Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively)	48 Participants	55 Participants	—	—

SECONDARY outcome

Timeframe: From baseline to Day 60

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

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

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=117 Participants 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.	Placebo Phase 2 n=115 Participants 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.	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.	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.
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	28 Participants	—	—
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	87 Participants	—	—
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	20 Participants	—	—
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	52 Participants	—	—
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	8 Participants	—	—
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	35 Participants	—	—

SECONDARY outcome

Timeframe: From baseline to Day 60

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=57 Participants 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.	Placebo Phase 2 n=62 Participants 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.	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.	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.
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	9 Participants	—	—
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	53 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=117 Participants 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.	Placebo Phase 2 n=115 Participants 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.	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.	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.
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	54 Participants	—	—
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	61 Participants	—	—
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	15 Participants	—	—
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	57 Participants	—	—
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	39 Participants	—	—
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	4 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=117 Participants 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.	Placebo Phase 2 n=115 Participants 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.	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.	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.
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	11 Participants	—	—
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	104 Participants	—	—
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	5 Participants	—	—
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	67 Participants	—	—
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	6 Participants	—	—
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	37 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=117 Participants 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.	Placebo Phase 2 n=115 Participants 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.	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.	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.
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	0 Participants	—	—
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	3 Participants	—	—
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	6 Participants	—	—
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	48 Participants	—	—
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	39 Participants	—	—
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	7 Participants	—	—
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	4 Participants	—	—
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	14 Participants	—	—
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	38 Participants	—	—
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	28 Participants	—	—
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	6 Participants	—	—
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	0 Participants	—	—
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	2 Participants	—	—
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	0 Participants	—	—
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	15 Participants	—	—
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	35 Participants	—	—
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	12 Participants	—	—
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	2 Participants	—	—
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	0 Participants	—	—
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	0 Participants	—	—
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	0 Participants	—	—
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	19 Participants	—	—
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	48 Participants	—	—
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	8 Participants	—	—
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	3 Participants	—	—
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	0 Participants	—	—
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	0 Participants	—	—
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	0 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=117 Participants 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.	Placebo Phase 2 n=115 Participants 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.	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.	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.
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 Interval 7.0 to 15.0	11 days Interval 8.0 to 14.0	—	—
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 Interval 5.0 to 11.0	9.5 days Interval 6.0 to 14.0	—	—
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 Interval 9.0 to 26.0	12 days Interval 9.0 to 15.0	—	—

SECONDARY outcome

Timeframe: From baseline to Day 60

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

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

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=117 Participants 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.	Placebo Phase 2 n=115 Participants 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.	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.	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.
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 Interval 8.0 to 19.0	13 days Interval 10.0 to 15.0	—	—
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 Interval 6.0 to 14.0	10 days Interval 7.0 to 14.0	—	—
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 Interval 14.0 to 29.0	15 days Interval 12.0 to 22.0	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=57 Participants 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.	Placebo Phase 2 n=62 Participants 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.	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.	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.
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 Interval 5.0 to 9.0	6 days Interval 5.0 to 9.0	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=117 Participants 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.	Placebo Phase 2 n=115 Participants 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.	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.	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.
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 Not estimable, insufficient number of participants with events.	NA days Not estimable, insufficient number of participants with events.	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=117 Participants 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.	Placebo Phase 2 n=115 Participants 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.	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.	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.
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 Not estimable, insufficient number of participants with events.	NA days Not estimable, insufficient number of participants with events.	—	—

SECONDARY outcome

Timeframe: From baseline to Day 60

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

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.

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=117 Participants 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.	Placebo Phase 2 n=115 Participants 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.	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.	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.
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	8.23 days Standard Deviation 6.91	—	—
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	6.50 days Standard Deviation 5.78	—	—
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	11.14 days Standard Deviation 7.69	—	—

SECONDARY outcome

Timeframe: From baseline to Day 60

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=57 Participants 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.	Placebo Phase 2 n=62 Participants 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.	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.	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.
For Phase 3 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60	5.81 days Standard Deviation 6.95	6.77 days Standard Deviation 6.41	—	—

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=3 Participants 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.	Placebo Phase 2 n=3 Participants 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.	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.	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.
For Phase 2 Only: Time to Attain an Undetectable Viral Load in Oropharyngeal Swabs. Positive SARS-CoV-2 result on Day 2	3 participants	0 participants	—	—
For Phase 2 Only: Time to Attain an Undetectable Viral Load in Oropharyngeal Swabs. Positive SARS-CoV-2 result on Day 5	0 participants	1 participants	—	—
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	3 participants	—	—
For Phase 2 Only: Time to Attain an Undetectable Viral Load in Oropharyngeal Swabs. Positive SARS-CoV-2 result on Day 3	0 participants	1 participants	—	—

SECONDARY outcome

Timeframe: On Days 1, 14, 29, 45 and 60

Population: ITT population

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.

Outcome measures

Outcome measures
Measure	LAU-7b Phase 2 n=117 Participants 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.	Placebo Phase 2 n=115 Participants 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.	LAU-7b Phase 3 n=57 Participants 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.	Placebo Phase 3 n=62 Participants 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.
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	0.599 score on a scale Standard Deviation 0.318	0.597 score on a scale Standard Deviation 0.308	0.517 score on a scale Standard Deviation 0.324
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	0.783 score on a scale Standard Deviation 0.218	0.745 score on a scale Standard Deviation 0.309	0.660 score on a scale Standard Deviation 0.324
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	0.853 score on a scale Standard Deviation 0.185	0.819 score on a scale Standard Deviation 0.263	0.754 score on a scale Standard Deviation 0.264
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 0.250	0.912 score on a scale Standard Deviation 0.139	0.824 score on a scale Standard Deviation 0.216	0.745 score on a scale Standard Deviation 0.308
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	0.920 score on a scale Standard Deviation 0.127	0.830 score on a scale Standard Deviation 0.180	0.774 score on a scale Standard Deviation 0.292

Adverse Events

LAU-7b Phase 2

Serious events: 23 serious events

Other events: 97 other events

Deaths: 14 deaths

Placebo Phase 2

Serious events: 22 serious events

Other events: 94 other events

Deaths: 11 deaths

LAU-7b Phase 3

Serious events: 12 serious events

Other events: 45 other events

Deaths: 3 deaths

Placebo Phase 3

Serious events: 13 serious events

Other events: 54 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Vice president Clinical Development

Laurent Pharmaceuticals Inc.

Phone: 514-941-2313

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place