NCT05258682|UnknownPhase 1/2DMCFDA Drug
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Sponsor study identifier
interventional
30
0 countries
N/A
Study Start
May 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 22, 2022
Actual (reported)February 28, 2022
Actual (reported)May 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Evaluate the treatment-emergent adverse events (AEs) of BromAc therapy following nebulised delivery
The safety and tolerability of BromAc will be assessed by characterising the symptoms or side effects of treatment (treatment-emergent adverse events) by the Common Toxicity Criteria for Adverse Events (CTCAE) v4.0
Following each nebulisation on days 1 to 5 and during follow up on days 6-15, 21, 28 and 60
Proportion of participants that proceed to invasive ventilation for deterioration of COVID-19 (need for mechanical ventilation)
Daily for 60 days
World Health Organisation (WHO) modified ordinal scale clinical score
Daily for 28 days
BromAc (Bromelain and Acetylcysteine combination) will be administered three times (3x) per day for five (5) days in a dose escalation format via inhalation using an approved vibrating mesh nebuliser (Aerogen Pro). Dose escalation concentration levels are BromAc 125ug/20mg/ml, 250ug/20mg/ml, 375ug/20mg/ml. All levels will receive 5ml of BromAc.
Bromelain combined with Acetylcysteine (BromAc), administered simultaneously.
Bromelain combined with Acetylcysteine (BromAc), administered simultaneously.
Frank MP van Haren, MD, PhD
St George Hospital, Director of Intensive Care
First Submitted
February 22, 2022
First Posted
February 28, 2022
Study Start
May 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 30, 2022
Estimated (date passed)Phase I-II Trial of Dendritic Cell Vaccine to Prevent COVID-19 in Adults
Improvement or deterioration in oxygenation
Daily for up to 14 days
All-cause mortality
Daily for 28 days
Dose related toxicities
Following each nebulisation on days 1 to 5 and during follow up on days 6-15, 21, 28 and 60
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 28, 2022
Record last verified: 2022-02
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Source: ClinicalTrials.gov.
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