drugset / Trial / NCT05258682

Safety of Nebulized Combination Therapy BromAc® in COVID-19 Respiratory Disease

NCT05258682

NaSingle-groupOpen-labelTreatment

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

EvaluationDrugModalityDoseRoute
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