Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19 (NCT NCT04784897)

Last Updated: 2022-09-16

Results Overview

Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the clinical status ordinal scale with response sustained through Day 29: 6\. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than for per protocol dosing or assessments, as appropriate); 7. Not hospitalized, limitation on activities and/or requiring home oxygen; 8. Not hospitalized, no limitations on activities

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

120 participants

Primary outcome timeframe

Day 1 through Day 29

Results posted on

2022-09-16

Participant Flow

Study participants were randomized to active or placebo, and dependent upon if prior to or after the scheduled interim safety analysis, were randomized to 3 days or 5 days of study treatment. For study analyses, subjects randomized to placebo were pooled since duration of placebo should not impact efficacy or safety outcomes. As the different treatment durations for Brilacidin have potential to impact efficacy and/or safety outcomes, 3-dose and 5-dose active arms were analyzed separately.

Participant milestones

Participant milestones
Measure	Pooled Placebo + SoC Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care..	Brilacidin 3-dose + SoC Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
Overall Study STARTED	60	16	44
Overall Study COMPLETED	56	14	42
Overall Study NOT COMPLETED	4	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Pooled Placebo + SoC Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care..	Brilacidin 3-dose + SoC Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
Overall Study Death	4	2	1
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pooled Placebo + SoC n=60 Participants Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=16 Participants Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC n=44 Participants Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.	Total n=120 Participants Total of all reporting groups
Age, Continuous	58.1 years n=93 Participants	61.4 years n=4 Participants	56.2 years n=27 Participants	57.8 years n=483 Participants
Age, Customized <=65 years	40 Participants n=93 Participants	10 Participants n=4 Participants	30 Participants n=27 Participants	80 Participants n=483 Participants
Age, Customized >65 years	20 Participants n=93 Participants	6 Participants n=4 Participants	14 Participants n=27 Participants	40 Participants n=483 Participants
Sex: Female, Male Female	31 Participants n=93 Participants	8 Participants n=4 Participants	16 Participants n=27 Participants	55 Participants n=483 Participants
Sex: Female, Male Male	29 Participants n=93 Participants	8 Participants n=4 Participants	28 Participants n=27 Participants	65 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	59 Participants n=93 Participants	15 Participants n=4 Participants	44 Participants n=27 Participants	118 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) White	59 Participants n=93 Participants	16 Participants n=4 Participants	43 Participants n=27 Participants	118 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Region of Enrollment United States	1 participants n=93 Participants	2 participants n=4 Participants	0 participants n=27 Participants	3 participants n=483 Participants
Region of Enrollment Russia	59 participants n=93 Participants	14 participants n=4 Participants	44 participants n=27 Participants	117 participants n=483 Participants
COVID-19 Severity Moderate	24 Participants n=93 Participants	6 Participants n=4 Participants	16 Participants n=27 Participants	46 Participants n=483 Participants
COVID-19 Severity Severe	36 Participants n=93 Participants	10 Participants n=4 Participants	28 Participants n=27 Participants	74 Participants n=483 Participants
Breathing Status Room Air	21 Participants n=93 Participants	7 Participants n=4 Participants	14 Participants n=27 Participants	42 Participants n=483 Participants
Breathing Status Low Flow O2	36 Participants n=93 Participants	7 Participants n=4 Participants	29 Participants n=27 Participants	72 Participants n=483 Participants
Breathing Status High Flow O2	2 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	4 Participants n=483 Participants
Breathing Status CPAP/BiPAP	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 29

Population: Intent-to-Treat (ITT) population, which includes all subjects who were randomized and receive at least one dose of study drug; subjects analyzed according to the treatment group to which they were randomized. For analyses, placebo subjects were pooled whereas the 3-dose and 5-dose active arms were analyzed separately. Censoring: Subjects not achieving recovery, lost to follow-up (for this endpoint) prior to achieving recovery, or who died prior to Day 29, were censored at Day 29.

Outcome measures

Outcome measures
Measure	Pooled Placebo + SoC n=60 Participants Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=16 Participants Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC n=44 Participants Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
Time to Sustained Recovery Through Day 29	12.00 days Interval 9.0 to 14.0	13.00 days Interval 9.0 to 16.0	13.00 days Interval 11.0 to 14.0

PRIMARY outcome

Timeframe: Day 5, Day 8, Day 11, Day 15, Day 29

Population: ITT population. For analyses, placebo subjects were pooled whereas the 3-dose and 5-dose active arms were analyzed separately. Censoring: Subjects not achieving recovery, lost to follow-up (for this endpoint) prior to achieving recovery, or who died prior to Day 29, were censored at Day 29.

Outcome measures

Outcome measures
Measure	Pooled Placebo + SoC n=60 Participants Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=16 Participants Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC n=44 Participants Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
Percentage of Participants With Sustained Recovery Through Day 29 By Day 5	8.33 percentage of participants	6.25 percentage of participants	4.55 percentage of participants
Percentage of Participants With Sustained Recovery Through Day 29 By Day 8	25.00 percentage of participants	18.75 percentage of participants	20.45 percentage of participants
Percentage of Participants With Sustained Recovery Through Day 29 By Day 11	43.33 percentage of participants	31.25 percentage of participants	34.09 percentage of participants
Percentage of Participants With Sustained Recovery Through Day 29 By Day 15	65.00 percentage of participants	62.50 percentage of participants	65.91 percentage of participants
Percentage of Participants With Sustained Recovery Through Day 29 By Day 29	90.00 percentage of participants	87.50 percentage of participants	93.18 percentage of participants

SECONDARY outcome

Timeframe: Day 29

Population: ITT population. For analyses, placebo subjects were pooled whereas the 3-dose and 5-dose active arms were analyzed separately.

Recovery status scores are the following three categories from the clinical status ordinal scale: 6\. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than for per protocol dosing or assessments, as appropriate); 7. Not hospitalized, limitation on activities and/or requiring home oxygen; 8. Not hospitalized, no limitations on activities

Outcome measures

Outcome measures
Measure	Pooled Placebo + SoC n=60 Participants Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=16 Participants Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC n=44 Participants Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
Number and Percentage of Participants Achieving Recovery Status Scores at Day 29	54 Participants	14 Participants	41 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: ITT population. For analyses, placebo subjects were pooled whereas the 3-dose and 5-dose active arms were analyzed separately.

Composite endpoint, defined as: Death OR Respiratory failure (requires invasive mechanical ventilation)

Outcome measures

Outcome measures
Measure	Pooled Placebo + SoC n=60 Participants Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=16 Participants Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC n=44 Participants Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
Number and Percentage of Participants Who Die or Develop Respiratory Failure by Day 29	3 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 1, Day 8, Day 15, Day 29

Population: ITT population. No. of participants at each timepoint is the sum across all 8 categories of the scale. For analyses, placebo subjects were pooled whereas the 3-dose and 5-dose active arms were analyzed separately.

Clinical status was measured with an 8-point ordinal scale: 1. Death 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring low-flow supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than for per protocol dosing or assessments, as appropriate) 7. Not hospitalized, limitation on activities and/or requiring home oxygen 8. Not hospitalized, no limitations on activities

Outcome measures

Outcome measures
Measure	Pooled Placebo + SoC n=60 Participants Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=16 Participants Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC n=44 Participants Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
Subject Clinical Status Day 8 · Score 1	1 Participants	0 Participants	0 Participants
Subject Clinical Status Day 8 · Score 5	23 Participants	9 Participants	20 Participants
Subject Clinical Status Day 8 · Score 6	2 Participants	1 Participants	1 Participants
Subject Clinical Status Baseline (Day 1) · Score 2	0 Participants	0 Participants	0 Participants
Subject Clinical Status Day 8 · Score 7	3 Participants	1 Participants	3 Participants
Subject Clinical Status Baseline (Day 1) · Score 4	35 Participants	7 Participants	29 Participants
Subject Clinical Status Baseline (Day 1) · Score 5	21 Participants	7 Participants	14 Participants
Subject Clinical Status Baseline (Day 1) · Score 6	0 Participants	0 Participants	0 Participants
Subject Clinical Status Baseline (Day 1) · Score 7	0 Participants	0 Participants	0 Participants
Subject Clinical Status Baseline (Day 1) · Score 8	0 Participants	0 Participants	0 Participants
Subject Clinical Status Day 8 · Score 2	0 Participants	1 Participants	0 Participants
Subject Clinical Status Baseline (Day 1) · Score 1	0 Participants	0 Participants	0 Participants
Subject Clinical Status Baseline (Day 1) · Score 3	4 Participants	2 Participants	1 Participants
Subject Clinical Status Day 8 · Score 3	4 Participants	2 Participants	2 Participants
Subject Clinical Status Day 8 · Score 4	15 Participants	1 Participants	12 Participants
Subject Clinical Status Day 8 · Score 8	12 Participants	1 Participants	6 Participants
Subject Clinical Status Day 15 · Score 1	1 Participants	1 Participants	1 Participants
Subject Clinical Status Day 15 · Score 2	1 Participants	0 Participants	0 Participants
Subject Clinical Status Day 15 · Score 3	3 Participants	1 Participants	1 Participants
Subject Clinical Status Day 15 · Score 4	5 Participants	1 Participants	5 Participants
Subject Clinical Status Day 15 · Score 5	11 Participants	3 Participants	8 Participants
Subject Clinical Status Day 15 · Score 6	0 Participants	1 Participants	5 Participants
Subject Clinical Status Day 15 · Score 7	4 Participants	1 Participants	3 Participants
Subject Clinical Status Day 15 · Score 8	35 Participants	8 Participants	21 Participants
Subject Clinical Status Day 29 · Score 1	3 Participants	2 Participants	2 Participants
Subject Clinical Status Day 29 · Score 2	0 Participants	0 Participants	0 Participants
Subject Clinical Status Day 29 · Score 3	2 Participants	0 Participants	0 Participants
Subject Clinical Status Day 29 · Score 4	1 Participants	0 Participants	1 Participants
Subject Clinical Status Day 29 · Score 5	0 Participants	0 Participants	0 Participants
Subject Clinical Status Day 29 · Score 6	0 Participants	0 Participants	0 Participants
Subject Clinical Status Day 29 · Score 7	2 Participants	1 Participants	1 Participants
Subject Clinical Status Day 29 · Score 8	52 Participants	13 Participants	40 Participants

SECONDARY outcome

Timeframe: Day 8, Day 15, Day 29

Population: ITT population. For analyses, placebo subjects were pooled whereas the 3-dose and 5-dose active arms were analyzed separately.

Outcome measures

Outcome measures
Measure	Pooled Placebo + SoC n=60 Participants Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=16 Participants Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC n=44 Participants Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
Number and Percentage of Participants Achieving at Least One Category Improvement in Clinical Status Day 8	30 Participants	6 Participants	20 Participants
Number and Percentage of Participants Achieving at Least One Category Improvement in Clinical Status Day 15	44 Participants	12 Participants	35 Participants
Number and Percentage of Participants Achieving at Least One Category Improvement in Clinical Status Day 29	55 Participants	14 Participants	41 Participants

SECONDARY outcome

Timeframe: Day 8, Day 15, Day 29

Population: ITT population. For analyses, placebo subjects were pooled whereas the 3-dose and 5-dose active arms were analyzed separately.

Outcome measures

Outcome measures
Measure	Pooled Placebo + SoC n=60 Participants Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=16 Participants Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC n=44 Participants Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
Number and Percentage of Participants Achieving at Least Two Category Improvement in Clinical Status Day 8	16 Participants	3 Participants	10 Participants
Number and Percentage of Participants Achieving at Least Two Category Improvement in Clinical Status Day 15	39 Participants	9 Participants	27 Participants
Number and Percentage of Participants Achieving at Least Two Category Improvement in Clinical Status Day 29	54 Participants	14 Participants	41 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: ITT population. For analyses, placebo subjects were pooled whereas the 3-dose and 5-dose active arms were analyzed separately.

Day to achieving improvement of one or more category on 8-point clinical status ordinal scale. Clinical status scale: 1. Death 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring low-flow supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than for per protocol dosing or assessments, as appropriate) 7. Not hospitalized, limitation on activities and/or requiring home oxygen 8. Not hospitalized, no limitations on activities

Outcome measures

Outcome measures
Measure	Pooled Placebo + SoC n=60 Participants Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=16 Participants Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC n=44 Participants Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
Time to at Least One Category Improvement in Clinical Status	7.00 days Interval 6.0 to 9.0	10.00 days Interval 5.0 to 13.0	8.00 days Interval 6.0 to 11.0

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: ITT population. For analyses, placebo subjects were pooled whereas the 3-dose and 5-dose active arms were analyzed separately.

Day to achieving improvement of two or more categories on 8-point clinical status ordinal scale. Clinical status scale: 1. Death 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring low-flow supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than for per protocol dosing or assessments, as appropriate) 7. Not hospitalized, limitation on activities and/or requiring home oxygen 8. Not hospitalized, no limitations on activities

Outcome measures

Outcome measures
Measure	Pooled Placebo + SoC n=60 Participants Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=16 Participants Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC n=44 Participants Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
Time to at Least Two Category Improvement in Clinical Status	12.50 days Interval 9.0 to 14.0	14.00 days Interval 10.0 to 17.0	13.00 days Interval 11.0 to 14.0

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: ITT population. For analyses, placebo subjects were pooled whereas the 3-dose and 5-dose active arms were analyzed separately. NEWS2 Censoring: Subjects with baseline score of 3 or higher, who did not reach NEWS2 of \<=2 by Day 29, were censored at last available assessment. Subjects who died were censored on date of death. For those subjects with a baseline score of \<=2, subjects were censored at baseline.

Time (in days) from randomization to achieve a NEWS2 score lower or equal to 2 being maintained for at least one 24-hour period. NEWS2 was assessed twice daily while hospitalized; if one of the components of the NEWS2 was missing at a particular time point, the NEWS2 was not calculated. The National Early Warning Score 2 (NEWS2) assesses a participant's degree of illness as assessed by clinical risk prediction categories based on a set of 7 clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0 to 3 was allocated to each parameter except supplemental oxygen use (score of 0 \[no\] or 2 \[yes\]) and level of consciousness (score of 0 \[alert, normal health condition\] or 3 \[altered mental state/confusion, worst health condition\]). All parameter scores were summed to get an aggregate NEWS2. NEWS2 ranges from 0 to 20, with higher scores meaning more severity/higher clinical risk

Outcome measures

Outcome measures
Measure	Pooled Placebo + SoC n=30 Participants Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=8 Participants Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC n=26 Participants Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
Time to a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for 24 Hours	3.00 days Interval 2.0 to 4.0	3.00 days Interval 2.0 to 4.0	3.00 days Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: Day 5, Day 8, Day 11, Day 15

The National Early Warning Score 2 (NEWS2) assesses a participant's degree of illness as assessed by clinical risk prediction categories based on a set of seven (7) clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0 to 3 was allocated to each parameter except supplemental oxygen use (score of 0 \[no\] or 2 \[yes\]) and level of consciousness (score of 0 \[alert, normal health condition\] or 3 \[altered mental state/confusion, worst health condition\]). All parameter scores were summed to get an aggregate NEWS2 assessment. Scoring for NEWS2 ranges from 0 to 20, with higher scores meaning more severity/higher clinical risk: low risk (score 1 to 4); low to medium risk (score of 3 in any individual parameter); medium risk (score 5 to 6); high risk (score 7 to 20).

Outcome measures

Outcome measures
Measure	Pooled Placebo + SoC n=30 Participants Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=8 Participants Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC n=26 Participants Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
Percentage of Participants Achieving a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for 24 Hours By Day 5	65.62 percentage of participants	72.73 percentage of participants	62.07 percentage of participants
Percentage of Participants Achieving a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for 24 Hours By Day 8	78.12 percentage of participants	72.73 percentage of participants	84.83 percentage of participants
Percentage of Participants Achieving a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for 24 Hours By Day 11	84.37 percentage of participants	72.73 percentage of participants	94.94 percentage of participants
Percentage of Participants Achieving a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for 24 Hours By Day 15	87.50 percentage of participants	72.73 percentage of participants	94.94 percentage of participants

SECONDARY outcome

Timeframe: Day 1 through Day 29

Outcome measures

Outcome measures
Measure	Pooled Placebo + SoC n=60 Participants Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=16 Participants Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC n=44 Participants Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
Change From Baseline in National Early Warning Score 2 (NEWS2) Day 3	-0.433 score Standard Error 0.225	-1.000 score Standard Error 0.524	-0.682 score Standard Error 0.200
Change From Baseline in National Early Warning Score 2 (NEWS2) Day 5	-1.150 score Standard Error 0.224	-1.500 score Standard Error 0.769	-1.455 score Standard Error 0.301
Change From Baseline in National Early Warning Score 2 (NEWS2) Day 8	-1.302 score Standard Error 0.262	-1.400 score Standard Error 0.804	-1.923 score Standard Error 0.341
Change From Baseline in National Early Warning Score 2 (NEWS2) Day 11	-1.472 score Standard Error 0.305	-2.167 score Standard Error 0.824	-2.400 score Standard Error 0.436
Change From Baseline in National Early Warning Score 2 (NEWS2) Day 15	-1.931 score Standard Error 0.285	-2.133 score Standard Error 0.940	-2.619 score Standard Error 0.330
Change From Baseline in National Early Warning Score 2 (NEWS2) Day 29	-2.339 score Standard Error 0.243	-2.667 score Standard Error 0.620	-3.073 score Standard Error 0.311

SECONDARY outcome

Timeframe: Day 1 through Day 60

Population: Safety population, which includes all subjects in the ITT population; subjects in this population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.

Treatment-Emergent Adverse Events (TEAEs) have onset dates on or after the study treatment start date

Outcome measures

Outcome measures
Measure	Pooled Placebo + SoC n=60 Participants Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=16 Participants Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC n=44 Participants Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
Number and Percentage of Participants With Treatment-Emergent Adverse Events At least one TEAE	39 Participants	14 Participants	39 Participants
Number and Percentage of Participants With Treatment-Emergent Adverse Events At least one Grade 3 (Severe) TEAE	9 Participants	6 Participants	7 Participants
Number and Percentage of Participants With Treatment-Emergent Adverse Events At least one Grade 4 (Life-threatening) TEAE	3 Participants	2 Participants	0 Participants
Number and Percentage of Participants With Treatment-Emergent Adverse Events At least one Grade 5 (Fatal) TEAE	4 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 60

Population: Safety population. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.

Treatment-Emergent adverse events have onset dates on or after the study treatment start date. Adverse Events of Special Interest (AESIs) are (i) hypertension Grade 3 or greater, and (ii) paresthesias / dysesthesias Grade 2 or greater, in accordance with CTCAE (version 5.0) criteria.

Outcome measures

Outcome measures
Measure	Pooled Placebo + SoC n=60 Participants Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=16 Participants Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC n=44 Participants Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
Number and Percentage of Participants With Treatment-Emergent Adverse Events of Special Interest At least one TEAE of special interest: hypertension Grade 3 or greater	2 Participants	3 Participants	2 Participants
Number and Percentage of Participants With Treatment-Emergent Adverse Events of Special Interest At least one TEAE of special interest: paresthesias/dysesthesias Grade 2 or greater	0 Participants	3 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 through Day 29

Population: ITT population. For analyses, placebo subjects were pooled whereas the 3-dose and 5-dose active arms were analyzed separately.

Incidence of death during the 28 days after start of study treatment

Outcome measures

Outcome measures
Measure	Pooled Placebo + SoC n=60 Participants Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=16 Participants Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC n=44 Participants Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
28-Day Mortality Rate	3 Participants	2 Participants	2 Participants

POST_HOC outcome

Timeframe: Day 1 through Day 29

Population: Pooled Placebo vs Brilacidin 5-dose arm analyzed, for Post-hoc Per Protocol (PP) CRP sub-group. Post-hoc PP population is a subset of ITT population with the following differences: * Excludes subjects with viral load \<10 copies/mL (i.e., below lower limit of quantitation) at baseline * Excludes subjects with \<3 days of study drug exposure * For 2 subjects who received the alternate treatment from which they were randomized, are switched to be analyzed according to actual treatment received

Outcome measures

Outcome measures
Measure	Pooled Placebo + SoC n=13 Participants Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=6 Participants Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
Time to Sustained Recovery Through Day 29 for Participant Sub-group With C-Reactive Protein (CRP) in the Highest Quartile (4th Quartile) at Baseline By 15 days (D16)	46.15 percentage of participants	83.33 percentage of participants	—
Time to Sustained Recovery Through Day 29 for Participant Sub-group With C-Reactive Protein (CRP) in the Highest Quartile (4th Quartile) at Baseline By 28 days (D29)	76.92 percentage of participants	100.00 percentage of participants	—

POST_HOC outcome

Timeframe: Day 1 through Day 29

Population: Pooled Placebo vs Brilacidin 5-dose arm analyzed, for Post-hoc Per Protocol (PP) IL-6 sub-group. Post-hoc PP population is a subset of ITT population with the following differences: * Excludes subjects with viral load \<10 copies/mL (i.e., below lower limit of quantitation) at baseline * Excludes subjects with \<3 days of study drug exposure * For 2 subjects who received the alternate treatment from which they were randomized, are switched to be analyzed according to actual treatment received

Outcome measures

Outcome measures
Measure	Pooled Placebo + SoC n=12 Participants Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=9 Participants Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
Time to Sustained Recovery Through Day 29 for Participant Sub-group With Interleukin-6 (IL-6) in the Highest Quartile (4th Quartile) at Baseline By 15 days (D16)	41.67 percentage of participants	66.67 percentage of participants	—
Time to Sustained Recovery Through Day 29 for Participant Sub-group With Interleukin-6 (IL-6) in the Highest Quartile (4th Quartile) at Baseline By 28 days (D29)	66.67 percentage of participants	88.89 percentage of participants	—

POST_HOC outcome

Timeframe: Day 1 through Day 29

Population: Pooled Placebo vs Brilacidin 5-dose arm analyzed, for Post-hoc Per Protocol (PP) SARS-CoV-2 viral load sub-group. Post-hoc PP pop is a subset of ITT with the following differences: * Excludes subjects with viral load \<10 copies/mL (i.e., below lower limit of quantitation) at baseline * Excludes subjects with \<3 days of study drug exposure * For 2 subjects who received the alternate treatment from which they were randomized, are switched to be analyzed according to actual treatment received

Outcome measures

Outcome measures
Measure	Pooled Placebo + SoC n=11 Participants Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=13 Participants Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
Time to Sustained Recovery Through Day 29 for Participant Sub-group With SARS-CoV-2 Viral Load in the Highest Quartile (4th Quartile) at Baseline By 15 days (D16)	54.55 percentage of participants	76.92 percentage of participants	—
Time to Sustained Recovery Through Day 29 for Participant Sub-group With SARS-CoV-2 Viral Load in the Highest Quartile (4th Quartile) at Baseline By 28 days (D29)	81.82 percentage of participants	92.31 percentage of participants	—

POST_HOC outcome

Timeframe: Day 1 through Day 29

Population: Pooled Placebo vs Brilacidin 5-dose arm analysis shown, for the Post-hoc Per Protocol (PP) sub-group starting study treatment \<7 days from onset of COVID-19 symptoms. Post-hoc PP pop is a subset of ITT with the following differences: * Excludes subjects with viral load \<10 copies/mL at baseline * Excludes subjects with \<3 days of study drug exposure * For 2 subjects who received the alternate treatment from which they were randomized, are switched to be analyzed according to actual treatment

Outcome measures

Outcome measures
Measure	Pooled Placebo + SoC n=14 Participants Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=5 Participants Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.
Time to Sustained Recovery Through Day 29 for Participant Sub-group With Start of Study Treatment Within Fewer Than 7 Days of Onset of COVID-19 Symptoms By 10 days (D11)	35.71 percentage of participants	60.00 percentage of participants	—
Time to Sustained Recovery Through Day 29 for Participant Sub-group With Start of Study Treatment Within Fewer Than 7 Days of Onset of COVID-19 Symptoms By 15 days (D16)	50.00 percentage of participants	100.00 percentage of participants	—

Adverse Events

Pooled Placebo + SoC

Serious events: 7 serious events

Other events: 39 other events

Deaths: 4 deaths

Brilacidin 3-dose + SoC

Serious events: 3 serious events

Other events: 14 other events

Deaths: 2 deaths

Brilacidin 5-dose + SoC

Serious events: 4 serious events

Other events: 39 other events

Deaths: 2 deaths

Total

Serious events: 14 serious events

Other events: 92 other events

Deaths: 8 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Pooled Placebo + SoC n=60 participants at risk Saline IV infusion, 3 to 5 daily doses, in addition to Standard of Care.	Brilacidin 3-dose + SoC n=16 participants at risk Brilacidin IV infusion, 3 daily doses, in addition to Standard of Care.	Brilacidin 5-dose + SoC n=44 participants at risk Brilacidin IV infusion, 5 daily doses, in addition to Standard of Care.	Total n=120 participants at risk Overall total
Investigations Alanine aminotransferase increased	18.3% 11/60 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	18.8% 3/16 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	25.0% 11/44 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	20.8% 25/120 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.
Investigations Aspartate aminotransferase increased	13.3% 8/60 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	12.5% 2/16 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	11.4% 5/44 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	12.5% 15/120 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.
Investigations Gamma-glutamyltransferase increased	13.3% 8/60 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	6.2% 1/16 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	9.1% 4/44 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	10.8% 13/120 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.
Investigations Blood pressure increased	8.3% 5/60 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	25.0% 4/16 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	6.8% 3/44 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	10.0% 12/120 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.
Investigations Serum ferritin increased	5.0% 3/60 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	0.00% 0/16 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	9.1% 4/44 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	5.8% 7/120 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.
Investigations Fibrin D dimer increased	6.7% 4/60 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	0.00% 0/16 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	4.5% 2/44 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	5.0% 6/120 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.
Nervous system disorders Hypoaesthesia	0.00% 0/60 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	12.5% 2/16 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	36.4% 16/44 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	15.0% 18/120 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.
Nervous system disorders Hypoaesthesia oral	0.00% 0/60 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	6.2% 1/16 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	20.5% 9/44 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	8.3% 10/120 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.
Nervous system disorders Paraesthesia	0.00% 0/60 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	25.0% 4/16 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	13.6% 6/44 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	8.3% 10/120 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.
Respiratory, thoracic and mediastinal disorders Respiratory failure	11.7% 7/60 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	18.8% 3/16 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	6.8% 3/44 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	10.8% 13/120 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.
Metabolism and nutrition disorders Hyperkalaemia	5.0% 3/60 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	0.00% 0/16 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	6.8% 3/44 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.	5.0% 6/120 • Day 1 through Day 60 Adverse events are summarized for the safety population, which includes all subjects in the ITT population analyzed according to treatment received. Subjects treated with placebo were pooled for analyses since duration of placebo should not impact outcomes. As the different treatment durations for Brilacidin have potential to impact outcomes, 3-dose and 5-dose active arms were analyzed separately.

Additional Information

Senior Vice President, Clinical Sciences

Innovation Pharmaceuticals Inc.

Phone: 978-921-4125

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of the disclosure agreement with investigators may vary. However, an investigator/institution may publish results, with any single center publication to be deferred until after a publication of results covering all centers in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER