Primary outcomeMedian· Day 1 through Day 29
Time to Sustained Recovery Through Day 29
| Group | Value (days) |
|---|---|
| Pooled Placebo + SoC | 12.00 |
| Brilacidin 3-dose + SoC | 13.00 |
| Brilacidin 5-dose + SoC | 13.00 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataA Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19
NCTNCT04784897 (opens ClinicalTrials.gov in a new tab)Other idIPI-BRIc-201
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 120 participants (actual)
- Sponsor
- Innovation Pharmaceuticals, Inc. · Industry
- Design
- Randomized · Quadruple masking
- Countries
2 countries
United States, Russia
- Start
- 22 Feb 2021
- Primary completion
- 1 Jul 2021
- Completion
- 30 Jul 2021
- First posted
- 5 Mar 2021
- Last update posted
- 16 Sept 2022
- Conditions
- COVID-19
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20212022
- Ph 2
A Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19
NCT0478489722 Feb 2021 to 30 Jul 2021
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The study assessed the efficacy and safety of Brilacidin for the treatment of COVID-19 in hospitalized participants
Interventions
- BrilacidinDrug
- PlaceboDrug
- Standard of Care (SoC)Drug
Arms2
Experimental
Brilacidin + SoC
Brilacidin IV infusion, 3 days and up to 5 days, in addition to Standard of Care
Placebo comparator
Placebo + SoC
Placebo IV infusion, 3 days and up to 5 days, in addition to Standard of Care
Primary outcomes2
Outcomes the sponsor listed as primary.
Time to Sustained Recovery Through Day 29
Time frame · Day 1 through Day 29
Registry description
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
Percentage of Participants With Sustained Recovery Through Day 29
Time frame · Day 5, Day 8, Day 11, Day 15, Day 29
Registry description
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 outcomes(12)
Number and Percentage of Participants Achieving Recovery Status Scores at Day 29
Time frame · Day 29
Registry description
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
Number and Percentage of Participants Who Die or Develop Respiratory Failure by Day 29
Time frame · Day 1 through Day 29
Registry description
Composite endpoint, defined as: Death OR Respiratory failure (requires invasive mechanical ventilation)
Subject Clinical Status
Time frame · Day 1, Day 8, Day 15, Day 29
Registry description
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
Number and Percentage of Participants Achieving at Least One Category Improvement in Clinical Status
Time frame · Day 8, Day 15, Day 29
Registry description
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
Number and Percentage of Participants Achieving at Least Two Category Improvement in Clinical Status
Time frame · Day 8, Day 15, Day 29
Registry description
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
Time to at Least One Category Improvement in Clinical Status
Time frame · Day 1 through Day 29
Registry description
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
Time to at Least Two Category Improvement in Clinical Status
Time frame · Day 1 through Day 29
Registry description
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
Time to a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for 24 Hours
Time frame · Day 1 through Day 29
Registry description
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
Percentage of Participants Achieving a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for 24 Hours
Time frame · Day 5, Day 8, Day 11, Day 15
Registry description
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).
Change From Baseline in National Early Warning Score 2 (NEWS2)
Time frame · Day 1 through Day 29
Registry description
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).
Number and Percentage of Participants With Treatment-Emergent Adverse Events
Time frame · Day 1 through Day 60
Registry description
Treatment-Emergent Adverse Events (TEAEs) have onset dates on or after the study treatment start date
Number and Percentage of Participants With Treatment-Emergent Adverse Events of Special Interest
Time frame · Day 1 through Day 60
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeNumber· Day 5, Day 8, Day 11, Day 15, Day 29
Percentage of Participants With Sustained Recovery Through Day 29
| Group | Value (percentage of participants) |
|---|---|
| Pooled Placebo + SoC | 8.33 |
| Brilacidin 3-dose + SoC | 6.25 |
| Brilacidin 5-dose + SoC | 4.55 |
Secondary and other outcome results(6)
Secondary outcomeCount of participants· Day 29
Number and Percentage of Participants Achieving Recovery Status Scores at Day 29
| Group | Value (Participants) |
|---|---|
| Pooled Placebo + SoC | 54 |
| Brilacidin 3-dose + SoC | 14 |
| Brilacidin 5-dose + SoC | 41 |
Secondary outcomeCount of participants· Day 1 through Day 29
Number and Percentage of Participants Who Die or Develop Respiratory Failure by Day 29
| Group | Value (Participants) |
|---|---|
| Pooled Placebo + SoC | 3 |
| Brilacidin 3-dose + SoC | 2 |
| Brilacidin 5-dose + SoC | 2 |
Secondary outcomeCount of participants· Day 1, Day 8, Day 15, Day 29
Subject Clinical Status
| Group | Value (Participants) |
|---|---|
| Pooled Placebo + SoC | 0 |
| Brilacidin 3-dose + SoC | 0 |
| Brilacidin 5-dose + SoC | 0 |
Secondary outcomeCount of participants· Day 8, Day 15, Day 29
Number and Percentage of Participants Achieving at Least One Category Improvement in Clinical Status
| Group | Value (Participants) |
|---|---|
| Pooled Placebo + SoC | 30 |
| Brilacidin 3-dose + SoC | 6 |
| Brilacidin 5-dose + SoC | 20 |
Secondary outcomeCount of participants· Day 8, Day 15, Day 29
Number and Percentage of Participants Achieving at Least Two Category Improvement in Clinical Status
| Group | Value (Participants) |
|---|---|
| Pooled Placebo + SoC | 16 |
| Brilacidin 3-dose + SoC | 3 |
| Brilacidin 5-dose + SoC | 10 |
Secondary outcomeMedian· Day 1 through Day 29
Time to at Least One Category Improvement in Clinical Status
| Group | Value (days) |
|---|---|
| Pooled Placebo + SoC | 7.00 |
| Brilacidin 3-dose + SoC | 10.00 |
| Brilacidin 5-dose + SoC | 8.00 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Pooled Placebo + SoCSaline IV infusion, 3 to 5 daily doses, in addition to Standard of Care. | 4 / 60 | 7 / 60 | 39 / 60 |
| Brilacidin 3-dose + SoCBrilacidin IV infusion, 3 daily doses, in addition to Standard of Care. | 2 / 16 | 3 / 16 | 14 / 16 |
| Brilacidin 5-dose + SoCBrilacidin IV infusion, 5 daily doses, in addition to Standard of Care. | 2 / 44 | 4 / 44 | 39 / 44 |
| TotalOverall total | 8 / 120 | 14 / 120 | 92 / 120 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 80 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Signed and dated written Informed Consent Form (ICF) to participate in the clinical study by patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative.
* Male or non-pregnant female adults between 18 and 80 years of age, inclusive, at time of informed consent.
* SARS-CoV-2 infection confirmed by positive standard polymerase chain reaction (PCR) test (or equivalent/ other approved diagnostic test) ≤ 4 days before randomization.
* Currently hospitalized and requiring medical care for COVID-19.
* Moderate OR severe COVID-19, defined by respiratory function at screening, as below:
* Moderate, meets at least one of the following criteria:
* Peripheral oxygen saturation SpO2 \> 93% on room air;
* Respiratory rate ≥ 20 to \< 30 breaths per minute.
* Severe, meets at least one of the following criteria:
* Peripheral oxygen saturation SpO2 ≤ 93% on room air OR arterial oxygen partial pressure (PaO2) / fraction of inspired oxygen (FiO2) \< 300mmHg (1mmHg=0.133kPa) \[corrective formulation should be used for higher altitude regions (over 1000m)\];
* Respiratory rate ≥ 30 breaths per minute.
* Body mass index (BMI) of ≥18 to \<40kg/m2 at screening.
* Agrees to the collection of nasopharyngeal (NP) swabs and venous blood per protocol.
* In the opinion of the investigator, willing and able to comply with the study protocol assessments, and is committed to the study and the study follow up visits.
Exclusion Criteria:
* Participation in any other clinical trial of an experimental agent treatment.
* Requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) at the time of randomization.
* Has explicitly expressed the wish not to receive intensive care support (Do not resuscitate or Do not intubate order) should this become necessary.
* In the opinion of the investigator, progression to death is imminent and inevitable within the next 72 hours, irrespective of the provision of treatment, such as rapidly progressive multiorgan failure.
* Requiring systemic anti-infective therapy for suspected or confirmed active bacterial/fungal/viral systemic infection other than COVID-19.
* Hypertensive urgency (e.g., SBP \>220 mmHg or DBP \>120 mmHg) or hypertensive emergency within the last 72 hours, as assessed by the investigator following local guidelines.
* If has a history of hypertension in the last 3 months, must have been receiving appropriate anti-hypertensive therapy in accordance with local guidelines.
* Evidence of moderate or severe hepatic impairment (Child-Pugh Class B or C).
* Estimated GFR (eGFR) \<30 mL/min/1.73m2 (based on CKD-EPI formula).
* Prior to a participant's study entry, known allergies or intolerance to Brilacidin or formulation excipients.
* Any serious medical or psychiatric condition or test abnormality(ies) that, in the investigator's judgment, puts the participant at significant risk, could confound the study results, or may interfere significantly with the subject's safe participation in and completion of the study.
* Pregnancy or breast-feeding, or positive urine or serum pregnancy test in a pre-dose assessment.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception throughout the study and for up to 30 days after stopping treatment.
* Sexually active males with female partners of childbearing potential unwilling to use a condom when engaging in intercourse of reproductive potential throughout the study and for up to 30 days after stopping treatment.
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