A Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Brilacidin; Placebo; Standard of Care (SoC)
Intervention description: Brilacidin IV infusion; Placebo IV infusion; SoC therapies for COVID-19
Intervention MeSH terms: Brilacidin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: SARS-CoV-2; coronavirus; Brilacidin; COVID-19

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

Eligibility 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.