Safety of nebulised delivery of BromAc® (Bromelain & Acetylcysteine) in healthy volunteers: a potential treatment for severe COVID-19

Mucpharm Pty Ltd0 个研究点目标入组 12 人开始时间: 2022年1月12日最近更新: 2022年9月19日

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•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

•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

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