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

• Status: Completed
• Trial end date: 2021-07-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovation Pharmaceuticals, Inc.

Criteria

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.