NCT04784897

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

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Innovation Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Brilacidin	Brilacidin IV infusion
DRUG	Placebo	Placebo IV infusion
DRUG	Standard of Care (SoC)	SoC therapies for COVID-19

Timeline

• Start date: 2021-02-22
• Primary completion: 2021-07-01
• Completion: 2021-07-30
• First posted: 2021-03-05
• Last updated: 2022-09-16
• Results posted: 2022-09-16

Locations

12 sites across 2 countries: United States, Russia

Regulatory

• FDA-regulated drug study