Trial · NCT04784897

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

NCT04784897, Phase 2, Completed, Innovation Pharmaceuticals, Inc.; results first posted 2022-09-16

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19. Trials, record NCT04784897. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04784897

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19
NCT number: NCT04784897
Status: Completed
Phases: Phase 2
Enrollment: 120 participants, actual
Lead sponsor: Innovation Pharmaceuticals, Inc.
Conditions: COVID-19
Interventions: Brilacidin, Placebo, Standard of Care (SoC)
First posted: 2021-03-05
Last updated: 2022-09-16
Results first posted: 2022-09-16

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to Sustained Recovery Through Day 29	Day 1 through Day 29	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
Primary	Percentage of Participants With Sustained Recovery Through Day 29	Day 5, Day 8, Day 11, Day 15, Day 29	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
Secondary	Number and Percentage of Participants Achieving Recovery Status Scores at Day 29	Day 29	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
Secondary	Number and Percentage of Participants Who Die or Develop Respiratory Failure by Day 29	Day 1 through Day 29	Composite endpoint, defined as: Death OR Respiratory failure (requires invasive mechanical ventilation)
Secondary	Subject Clinical Status	Day 1, Day 8, Day 15, Day 29	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
Secondary	Number and Percentage of Participants Achieving at Least One Category Improvement in Clinical Status	Day 8, Day 15, Day 29	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
Secondary	Number and Percentage of Participants Achieving at Least Two Category Improvement in Clinical Status	Day 8, Day 15, Day 29	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
Secondary	Time to at Least One Category Improvement in Clinical Status	Day 1 through Day 29	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
Secondary	Time to at Least Two Category Improvement in Clinical Status	Day 1 through Day 29	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
Secondary	Time to a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for 24 Hours	Day 1 through Day 29	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

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes19

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Sustained Recovery Through Day 29	Day 1 through Day 29	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.	days	MEDIAN
PRIMARY	Percentage of Participants With Sustained Recovery Through Day 29	Day 5, Day 8, Day 11, Day 15, Day 29	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.	percentage of participants	NUMBER
SECONDARY	Number and Percentage of Participants Achieving Recovery Status Scores at Day 29	Day 29	ITT population. For analyses, placebo subjects were pooled whereas the 3-dose and 5-dose active arms were analyzed separately.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number and Percentage of Participants Who Die or Develop Respiratory Failure by Day 29	Day 1 through Day 29	ITT population. For analyses, placebo subjects were pooled whereas the 3-dose and 5-dose active arms were analyzed separately.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Subject Clinical Status	Day 1, Day 8, Day 15, Day 29	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number and Percentage of Participants Achieving at Least One Category Improvement in Clinical Status	Day 8, Day 15, Day 29	ITT population. For analyses, placebo subjects were pooled whereas the 3-dose and 5-dose active arms were analyzed separately.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number and Percentage of Participants Achieving at Least Two Category Improvement in Clinical Status	Day 8, Day 15, Day 29	ITT population. For analyses, placebo subjects were pooled whereas the 3-dose and 5-dose active arms were analyzed separately.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time to at Least One Category Improvement in Clinical Status	Day 1 through Day 29	ITT population. For analyses, placebo subjects were pooled whereas the 3-dose and 5-dose active arms were analyzed separately.	days	MEDIAN
SECONDARY	Time to at Least Two Category Improvement in Clinical Status	Day 1 through Day 29	ITT population. For analyses, placebo subjects were pooled whereas the 3-dose and 5-dose active arms were analyzed separately.	days	MEDIAN
SECONDARY	Time to a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for 24 Hours	Day 1 through Day 29	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.	days	MEDIAN

1 to 10 of 19Source ClinicalTrials.gov

See all 19 outcomes

Results by group214

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Time to Sustained Recovery Through Day 29	Pooled Placebo + SoC		12.00	90% Confidence Interval 9.00 to 14.00	days
Time to Sustained Recovery Through Day 29	Brilacidin 3-dose + SoC		13.00	90% Confidence Interval 9.00 to 16.00	days
Time to Sustained Recovery Through Day 29	Brilacidin 5-dose + SoC		13.00	90% Confidence Interval 11.00 to 14.00	days
Percentage of Participants With Sustained Recovery Through Day 29	Pooled Placebo + SoC	By Day 5	8.33		percentage of participants
Percentage of Participants With Sustained Recovery Through Day 29	Brilacidin 3-dose + SoC	By Day 5	6.25		percentage of participants
Percentage of Participants With Sustained Recovery Through Day 29	Brilacidin 5-dose + SoC	By Day 5	4.55		percentage of participants
Percentage of Participants With Sustained Recovery Through Day 29	Pooled Placebo + SoC	By Day 8	25.00		percentage of participants
Percentage of Participants With Sustained Recovery Through Day 29	Brilacidin 3-dose + SoC	By Day 8	18.75		percentage of participants
Percentage of Participants With Sustained Recovery Through Day 29	Brilacidin 5-dose + SoC	By Day 8	20.45		percentage of participants
Percentage of Participants With Sustained Recovery Through Day 29	Pooled Placebo + SoC	By Day 11	43.33		percentage of participants

1 to 10 of 214Source ClinicalTrials.gov

See all 214 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pooled Placebo + SoC	60
Overall Study	STARTED	Brilacidin 3-dose + SoC	16
Overall Study	STARTED	Brilacidin 5-dose + SoC	44
Overall Study	COMPLETED	Pooled Placebo + SoC	56
Overall Study	COMPLETED	Brilacidin 3-dose + SoC	14
Overall Study	COMPLETED	Brilacidin 5-dose + SoC	42
Overall Study	NOT COMPLETED	Pooled Placebo + SoC	4
Overall Study	NOT COMPLETED	Brilacidin 3-dose + SoC	2
Overall Study	NOT COMPLETED	Brilacidin 5-dose + SoC	2

Source ClinicalTrials.gov

Adverse events108

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Alanine aminotransferase increased	Investigations	Pooled Placebo + SoC	11	60
other	Alanine aminotransferase increased	Investigations	Brilacidin 3-dose + SoC	3	16
other	Alanine aminotransferase increased	Investigations	Brilacidin 5-dose + SoC	11	44
other	Alanine aminotransferase increased	Investigations	Total	25	120
other	Aspartate aminotransferase increased	Investigations	Pooled Placebo + SoC	8	60
other	Aspartate aminotransferase increased	Investigations	Brilacidin 3-dose + SoC	2	16
other	Aspartate aminotransferase increased	Investigations	Brilacidin 5-dose + SoC	5	44
other	Aspartate aminotransferase increased	Investigations	Total	15	120
other	Gamma-glutamyltransferase increased	Investigations	Pooled Placebo + SoC	8	60
other	Gamma-glutamyltransferase increased	Investigations	Brilacidin 3-dose + SoC	1	16

1 to 10 of 108Source ClinicalTrials.gov

See all 108 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pooled Placebo + SoC	4	60
Total, all-cause mortality	Brilacidin 3-dose + SoC	2	16
Total, all-cause mortality	Brilacidin 5-dose + SoC	2	44
Total, all-cause mortality	Total	8	120
Total, other adverse events	Pooled Placebo + SoC	39	60
Total, other adverse events	Brilacidin 3-dose + SoC	14	16
Total, other adverse events	Brilacidin 5-dose + SoC	39	44
Total, other adverse events	Total	92	120
Total, serious adverse events	Pooled Placebo + SoC	7	60
Total, serious adverse events	Brilacidin 3-dose + SoC	3	16

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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