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

NCT05258682 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-02-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Bromelains

Bromelain combined with Acetylcysteine (BromAc), administered simultaneously.

DRUG

Acetylcysteine

Bromelain combined with Acetylcysteine (BromAc), administered simultaneously.

Sponsors & Collaborators

  • St George Hospital, Australia

    collaborator OTHER

  • Mucpharm Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Frank MP van Haren, MD, PhD · St George Hospital, Director of Intensive Care

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2022-09-30
Completion
2022-10-30
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05258682 on ClinicalTrials.gov