Safety of Nebulized Combination Therapy BromAc® in COVID-19 Respiratory Disease
Summary
COVID-19 has multiple facets including cytokine storm, thromboembolism and gelatinous secretions. It is known that oxygen exchange is the main problem in patients with COVID-19 and hypoxia is one of the most serious, in which patients succumb to acute respiratory distress syndrome (ARDS). In other severe respiratory disease such as ventilator associated pneumonia (VAP), formation of biofilm in the endotracheal tube causes infection to spread to the lungs, resulting in respiratory decline and high mortality. The development of gelatinous sputum plugs correlates with negative outcome. Both groups of patients still have limited therapy options. BromAc is a potent mucolytic, biofilm degrader, cleaves the glycoproteins of the SARS-CoV-2 virus (antiviral), and down regulates cytokines and chemokine in COVID-19 sputum. The investigators seek to examine the safety and attempt to gain preliminary efficacy of nebulised BromAc in moderate to severe COVID-19 and other mucus producing, severe, respiratory diseases.
Timeline
- Start
- 2022-05-01
- Primary completion
- 2022-09-30
- Completion
- 2022-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bromelain | Protein / enzyme biologic | 125 ug/ml | Inhaled |
| Subject | Bromelain | Protein / enzyme biologic | 250 ug/ml | Inhaled |
| Subject | Bromelain | Protein / enzyme biologic | 375 ug/ml | Inhaled |
| Subject | N-acetylcysteine | Small molecule | 20 mg/ml | Inhaled |