ANZCTR - Registration

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05220605

Registration number

NCT05220605

Ethics application status

Date submitted

24/01/2022

Date registered

2/02/2022

Date last updated

15/09/2022

Titles & IDs

Public title

Nebulised BromAc in Healthy Volunteers

Scientific title

Safety of Nebulised Delivery of BromAc® (Bromelain & Acetylcysteine) in Healthy Volunteers: a Potential Treatment for Severe COVID-19

Secondary ID [1]

MUC-COV-002

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Condition category

Condition code

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Comparator / control treatment

Control group

Outcomes

Eligibility

Key inclusion criteria

* Aged 18 to 70 years
* Received complete vaccination against COVID-19 over one week from trial commencement, able to adhere to Health guidelines surrounding attendance to a public hospital, and completion of any hospital questionnaires
* Are considered suitable for the trial based on ability to follow protocol and provide informed consent
* Are within a 10km radius of a study centre for ensuring adherence to trial procedures and follow up

Minimum age

18 Years

Maximum age

70 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

* Have been in contact with a known case of COVID-19 or advised to undertake self-isolation
* Have known allergy (anaphylaxis) or sensitivity to pineapples, papain, bromeliads, (fruit or plant) sulphur, eggs or Acetylcysteine that cannot be managed with steroids or antihistamine prophylaxis or any other serious unrelated allergy
* Have symptoms of COVID-19 such as cough or shortness of breath or evidence of pulmonary disease, other respiratory disease including asthma or chronic obstructive pulmonary disease
* Have a coagulation disorder of any kind or are on anticoagulant or anti-platelet therapy, history of nose bleeds or easy bruising
* ECOG >2
* Have any other serious comorbidities where inclusion in the trial will subject the patient to a higher risk of adverse events
* Pregnant women are excluded from this study because BromAc has unknown but a potential risk for adverse events in nursing infants secondary to treatment of the mother. Breastfeeding should be discontinued if the mother is treated with BromAc
* Patients with psychiatric illness/social situations that would limit compliance with study requirements
* Are unable to give fully informed and educated consent or are unable to comply with the standard follow up procedures of a clinical trial

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other

Other design features

Phase

Phase 1

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

27/07/2022

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

25/08/2022

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Mucpharm Pty Ltd

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

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.

Trial website

https://clinicaltrials.gov/study/NCT05220605

Trial related presentations / publications

Public notes

 This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts

Principal investigator

Name

Frank van Haren, MD, PhD

Address

St George Hospital, Director of Intensive Care

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05220605

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05220605