A Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- COVID-19
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
This Phase 2 study is a randomized, blinded, placebo-controlled, parallel group design. The target population to be treated are patients with moderate to severe COVID-19, SARS-CoV-2 infection confirmed by positive standard polymerase chain reaction (PCR) test (or equivalent/ other approved diagnosti...
This Phase 2 study is a randomized, blinded, placebo-controlled, parallel group design. The target population to be treated are patients with moderate to severe COVID-19, 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 hospitalized with respiratory distress but not yet requiring high-level respiratory support (as defined in exclusion criterion #2). See inclusion/exclusion criteria. The study is comprised of three parts: Screening/ Baseline visit (Day -1 to 1): Lasts up to 24-48 hours and comprises screening/ baseline assessments. This visit will confirm that study inclusion and exclusion criteria are met by participants prior to randomization. Treatment period (Day 1-3 with potential to expand to Day 4-5): Randomized subjects will receive blinded study treatment once daily for 3 days by IV infusion, in addition to SoC. Follow-up period (Day 4-6 through Day 60): Subjects will be assessed daily while hospitalized. Discharged patients will be asked to attend study visits at Days 15 and 29. A follow-up visit at Day 60(±10), by telephone call, is also included to confirm patient status. All subjects will undergo a series of efficacy and safety assessments, including laboratory assays. Additional blood samples and nasopharyngeal (NP) swabs will also be obtained (oropharyngeal (OP) swabs to be collected only in exceptional circumstances). The study started with 3 days of study drug administration. After an interim analysis safety review, by an independent Data Monitoring Committee (DMC), dosing has since been extended to 5 days.
Tracking Information
- NCT #
- NCT04784897
- Collaborators
- Not Provided
- Investigators
- Study Director: Innovation Pharmaceuticals Inc. Innovation Pharmaceuticals, Inc.