Status:
UNKNOWN
Safety of Nebulized Combination Therapy BromAc® in COVID-19 Respiratory Disease
Lead Sponsor:
Mucpharm Pty Ltd
Collaborating Sponsors:
St George Hospital, Australia
Conditions:
COVID-19 Pneumonia
COVID-19
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 t...
Detailed Description
It is well known that oxygen exchange is a major problem in patients with COVID-19 and hypoxia is one of the most serious effects, where patients succumb from acute respiratory distress syndrome (ARDS...
Eligibility Criteria
Inclusion
- Aged 18 years to 75 years old
- Admitted to hospital for management of COVID-19 with moderate or severe disease
- Positive testing by virologic test (i.e. SARS-CoV-2 based qRT-PCR)
- Clinical signs suggestive of moderate or severe disease such as oxygen saturation (SpO2) less than 93% on room air or where the participant requires oxygen support such as nasal cannulas, mask, non-rebreather mask, high flow nasal cannulas
Exclusion
- Patients that have critical disease and are mechanically ventilated
- Undergoing other airway administered mucolytic therapy for e.g. dornase alfa within 24 hours, or are enrolled in another clinical trial for COVID-19
- Have known allergy, anaphylaxis or intolerance to pineapples, papain, bromeliads, sulphur, eggs or Acetylcysteine or any other serious allergy or intolerance to fruits or food products or any other serious allergy or allergen triggered asthma, such as dust or pollen
- Have other serious comorbidities where inclusion in the trial will subject the participant to a higher risk of adverse events, including participants with asthma (existing severe lung disease such as COPD, bronchiectasis and cystic fibrosis are not exclusion criteria)
- 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
- Participants 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 :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05258682
Start Date
May 1 2022
End Date
October 30 2022
Last Update
February 28 2022
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