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

NCT04784897 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IPI-BRIc-201
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 12

Brief Summary

The study assessed the efficacy and safety of Brilacidin for the treatment of COVID-19 in hospitalized participants

Conditions

COVID-19

Keywords

SARS-CoV-2; coronavirus; Brilacidin; COVID-19

Outcome Measures

Primary Outcomes (2)

• Time to Sustained Recovery 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

  Day 1 through Day 29

• Percentage of Participants With Sustained Recovery 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

  Day 5, Day 8, Day 11, Day 15, Day 29

Secondary Outcomes (12)

• Number and Percentage of Participants Achieving Recovery Status Scores at Day 29

  Day 29

• Number and Percentage of Participants Who Die or Develop Respiratory Failure by Day 29

  Day 1 through Day 29

• Subject Clinical Status

  Day 1, Day 8, Day 15, Day 29

• Number and Percentage of Participants Achieving at Least One Category Improvement in Clinical Status

  Day 8, Day 15, Day 29

• Number and Percentage of Participants Achieving at Least Two Category Improvement in Clinical Status

  Day 8, Day 15, Day 29

Other Outcomes (1)

• 28-Day Mortality Rate

  Day 1 through Day 29

Study Arms (2)

Brilacidin + SoC

EXPERIMENTAL

Brilacidin IV infusion, 3 days and up to 5 days, in addition to Standard of Care

Drug: Brilacidin; Drug: Standard of Care (SoC)

Placebo + SoC

PLACEBO COMPARATOR

Placebo IV infusion, 3 days and up to 5 days, in addition to Standard of Care

Drug: Placebo; Drug: Standard of Care (SoC)

Interventions

Brilacidin DRUG

Brilacidin IV infusion

Brilacidin + SoC

Placebo DRUG

Placebo IV infusion

Placebo + SoC

Standard of Care (SoC) DRUG

SoC therapies for COVID-19

Brilacidin + SoC; Placebo + SoC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovation Pharmaceuticals, Inc.: lead

Study Sites (12)

IPI Investigator Site

Winfield, Illinois, 60190, United States

Location

IPI Investigator Site

Toledo, Ohio, 43608, United States

Location

IPI Investigator Site

Barnaul, 656045, Russia

Location

IPI Investigator Site

Moscow, 111398, Russia

Location

IPI Investigator Site

Moscow, 119048, Russia

Location

IPI Investigator Site

Moscow, 121359, Russia

Location

IPI Investigator Site

Moscow, 125367, Russia

Location

IPI Investigator Site

Nizniy Novgorod, 603155, Russia

Location

IPI Investigator Site

Pushkin, 196600, Russia

Location

IPI Investigator Site

Saint Petersburg, 198205, Russia

Location

IPI Investigator Site

Saint Petersburg, 198510, Russia

Location

IPI Investigator Site

Saint Petersburg, 199106, Russia

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

brilacidin; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Senior Vice President, Clinical Sciences
• Organization: Innovation Pharmaceuticals Inc.

info@ipharminc.com

978-921-4125

Study Officials

• Innovation Pharmaceuticals Inc.

  Innovation Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 5, 2021
• Study Start: February 22, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 30, 2021
• Last Updated: September 16, 2022
• Results First Posted: September 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); RU (10)