Safety and efficacy of intranasal delivery of BromAc® (Bromelain & Acetylcysteine) in swab positive SARS-CoV-2 patients – a phase I, single-arm, dose escalation study

Mucpharm Pty Ltd0 个研究点目标入组 40 人开始时间: 2020年8月5日最近更新: 2020年12月7日

试验速览

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•Aged 18 years or older
•Swab positive for SARS-CoV-2 based on RT-PCR (patients must be identified and commence treatment within 3 days of the positive result)
•Diagnostic PCR or pre-treatment PCR must have viral load titre measurement
•Swabbed within 48 hours of symptom onset
•Remain generally well and as an outpatient in isolation in their home
•Are considered suitable for the trial based on ability to follow protocol and provide informed consent
•Are within a 50km radius of a study centre for ensuring adherence to trial procedures and follow up

•Have symptoms from SARS-CoV-2 that warrant admission to hospital, require supplemental oxygen therapy or are an inpatient in a hospital for SARS-CoV-2
•Are unwilling to undergo repeat swab for PCR viral load
•On anti-viral therapy for SARS-CoV-2 (for e.g. Remdesivir, Interferon-beta1alpha) or are enrolled in another clinical trial for SARS-CoV-2
•Have known allergy (anaphylaxis) to pineapples, papain, bromeliads, sulphur, eggs or Acetylcysteine that cannot be managed with steroids or antihistamine prophylaxis or any other serious unrelated allergy
•Have a coagulation disorder of any kind or are on anticoagulant or anti-platelet therapy that cannot be withheld for the treatment period
•Have other serious comorbidities where inclusion in the trial will subject the patient to a higher risk of adverse events, including patients with uncontrolled intercurrent illness
•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

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