Status:
COMPLETED
Nebulised BromAc in Healthy Volunteers
Lead Sponsor:
Mucpharm Pty Ltd
Collaborating Sponsors:
St George Hospital, Australia
Mobius Medical Pty Ltd.
Conditions:
COVID-19 Pneumonia
Bromelains Adverse Reaction
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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....
Detailed Description
The SARS-CoV-2 virus, with its clinical syndrome known as COVID-19, has a spike protein (S), nucleocapsid protein (N) that contains the RNA, membrane protein (M) and the envelope protein (E). The spik...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05220605
Start Date
July 27 2022
End Date
August 25 2022
Last Update
September 15 2022
Active Locations (1)
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1
St George Hospital
Kogarah, New South Wales, Australia, 2217