None listed
Conditions
Brief summary
COVID-19 has multiple facets including cytokine storm, thromboembolism, renal impairment, and mucinous secretions. It is known that oxygen exchange is the main problem in patients with COVID-19 and hypoxia is one of the most serious effects, in which patients succumb to acute respiratory distress syndrome (ARDS). The development of mucinous sputum plugs in individuals infected with SARS-CoV-2 in addition to cytokine storm is of great clinical importance, correlating with negative outcome. Bromelain and Acetylcysteine (BromAc) is a potent mucolytic applied in highly mucinous tumours of the appendix. Previous research has shown that BromAc cleaves the glycoproteins of the SARS-CoV-2 virus (antiviral), is a mucolytic, dissolving COVID-19 and other respiratory sputum in clinically relevant times, and down regulates cytokines and chemokines in sputum from ventilated COVID-19 patients. The investigators now seek to examine the safety of nebulised BromAc in healthy volunteers to assess any symptoms or side effects prior to progressing towards a potential treatment option in patients with severe COVID-19.
Interventions
This is a phase I study on the safety of BromAc, where 12 healthy volunteers who are otherwise well and remain in the outpatient setting will receive BromAc as a nebulised aerosol into the respiratory tract once daily for three days, in a dose escalation format.
Dose escalation will be Bromelain 100ug/ml, 150ug/ml or 200ug/ml in combination with Acetylcysteine 20mg/ml. Doses will be increased after every 4 patients, with the first patient receiving dose level 1 (BromAc 100ug/20mg/ml). If safe,
This is a phase I study on the safety of BromAc, where 12 healthy volunteers who are otherwise well and remain in the outpatient setting will receive BromAc as a nebulised aerosol into the respiratory tract once daily for three days, in a dose escalation format. Dose escalation will be Bromelain 100ug/ml, 150ug/ml or 200ug/ml in combination with Acetylcysteine 20mg/ml. Doses will be increased after every 4 patients, with the first patient receiving dose level 1 (BromAc 100ug/20mg/ml). If safe, dose escalation will occur to the next level based on the number of dose limiting toxicities. Dose escalation to the next level will occur after treatment of 4 patients at each level has been completed at the end of day 3. BromAc is a product that combines two existing products (Bromelain and Acetylcysteine), along with 0.9% normal saline to be delivered into the respiratory tract via nebulised aerosol delivery through a mask, which will be administered by a nurse or member of the study team. The nebulisation will take approximately 20 minutes. Doses will be administered under clinic monitoring. The participant will be assessed for symptoms and side effects during nebulisation of BromAc and for 2 hours following completion of nebulisation. Clinical observations and a symptom assessment questionnaire will be completed on days 1, 2 and 3 with a blood test at the end of day 3 treatment. Follow up phone calls will occur on days 5 and 10, with a symptom assessment questionnaire.
Sponsors
Mucpharm Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
• Aged 18 to 60 years • Remain generally well and as an outpatient • Received the first vaccination for COVID-19, able to adhere to NSW 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 criteria
• Have been in contact with a known case of COVID-19 or advised to undertake self-isolation in the last 14 days • 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 • Have any other serious comorbidities where inclusion in the trial will subject the participant 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 • People 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
Outcome results
None listed