A Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

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

Detailed description: 
      This Phase 2 study was a randomized, blinded, placebo-controlled, parallel group design.

      The target population treated were patients with moderate to severe COVID-19, active
      SARS-CoV-2 infection confirmed by positive standard polymerase chain reaction (PCR) test (or
      equivalent/ other approved diagnostic test) within 4 days prior to starting study treatment,
      and were hospitalized with respiratory distress but not yet requiring high-level respiratory
      support (as defined in exclusion criterion #2). See inclusion/exclusion criteria.

      For each participant, the study was comprised of three parts:

        1. Screening/ Baseline visit (Day -1 to 1): Lasting up to 24-48 hours and comprised
           screening/ baseline assessments. This visit was to confirm that study inclusion and
           exclusion criteria were met by participants prior to randomization.

        2. Treatment period (Day 1-3 or Day 1-5): Randomized subjects received blinded study
           treatment once daily for 3 or 5 days by IV infusion, in addition to Standard of Care
           (SoC).

        3. Follow-up period (Day 4 or 6 through Day 60): Subjects were assessed daily while
           hospitalized. Discharged patients were asked to attend study visits at Days 15 and 29. A
           follow-up visit at Day 60(±10), by telephone call, was performed to confirm patient
           status.

      All participants had a series of efficacy and safety assessments performed, including
      laboratory assays. Additional blood samples and nasopharyngeal (NP) swabs were also obtained
      (oropharyngeal (OP) swabs were to be collected only in exceptional circumstances).

      Study participants/subjects were randomized to active or placebo, and the study started with
      3 days of study drug administration. After an interim analysis safety review, by an
      independent Data Monitoring Committee (DMC), dosing was extended to 5 days. Hence, subjects
      recruited after the interim analysis received 5 days of study treatment.

      For study analyses, subjects randomized to placebo were pooled since duration of placebo
      should not impact efficacy or safety outcomes. As the different treatment durations for
      Brilacidin have potential to impact efficacy and/or safety outcomes, 3-dose and 5-dose active
      arms were analyzed separately.
    

Intervention name(s): Brilacidin; Placebo; Standard of Care (SoC)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Brilacidin IV infusion; Placebo IV infusion; SoC therapies for COVID-19
Intervention MeSH terms: Brilacidin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SARS-CoV-2; coronavirus; Brilacidin; COVID-19