COVID-19 is a disease that has multiple facets including an inflammatory storm, it promotes
blood clotting and causes kidney damage, mucinous secretions in the lung are of great
importance to outcome. Increasingly sticky sputum is associated with critical illness, with
considerably raised levels of a specific type of mucous protein (MUC5AC) in sputum in
COVID-19 patients. There is a strong link between viral infection and mucus production via
multiple inter-cellular signalling pathways including Interleukin (IL)6, IL10 and Tumour
Necrosis Factor (TNF) whereby the inflammatory storm causes sudden secretion of high volumes
of dense mucus.
An Australian pharmaceutical company has developed BromAc (Bromelain & Acetylcysteine) for
the palliative treatment of highly mucinous tumors of the appendix and lung. During
pre-clinical development, they found that BromAc® rapidly dissolved and removed tumour mucin,
making it a potent mucolytic. In combination, bromelain and acetylcysteine disrupt the
architecture of the SARS-COV-2 virus in a way that renders it non-infective, reduced
cytokines and chemokines in COVID-19 sputum and is a highly effective respiratory mucolytic.
The aim of this study is to assess whether BromAc delivered into the respiratory tract as a
nebulised aerosol is tolerated and safe at three specific concentrations in healthy volunteer
participants. The investigators will further assess the safety of nebulised BromAc and
efficacy of the drug product as a mucolytic and anti-inflammatory, and whether this improves
clinical outcome in participants with COVID-19. The hypothesis is that BromAc will be
tolerated by patients and will result in mucus clearance, improving oxygenation and
compliance in those that are ventilated.
This is a phase I study on the safety of BromAc, where 12 healthy volunteers will receive
BromAc as a nebulised aerosol into the respiratory tract. BromAc is a product that combines
two existing products to be delivered into the respiratory tract via nebulised aerosol
delivery through a mask. The participant will be assessed for symptoms and side effects. The
participant will receive nebulised BromAc at the allocated dose level for a total of 3 days.
The hypothesis is that nebulised airway delivery of BromAc will be safe at the concentrations
assessed.
Phase:
Phase 1
Details
Lead Sponsor:
Mucpharm Pty Ltd
Collaborators:
Mobius Medical Pty Ltd. St George Hospital, Australia