STC3141 - An Open Label, Multi-Centre Study to Determine the Safety and Efficacy of STC3141 Administered as an Infusion for up to 5 Days in Subjects with COVID-19 Respiratory Distress Syndrome Requiring Intensive Care [2020] NSWCATGD 16

NSW Civil and Administrative Tribunal New South Wales Medium Neutral Citation: STC3141 - An Open Label, Multi-Centre Study to Determine the Safety and Efficacy of STC3141 Administered as an Infusion for up to 5 Days in Subjects with COVID-19 Respiratory Distress Syndrome Requiring Intensive Care [2020] NSWCATGD 16 Hearing dates: 24 April 2020 Date of orders: 24 April 2020 Decision date: 24 April 2020 Jurisdiction: Guardianship Division Before: M D Schyvens, Deputy President Dr M J Wroth, Senior Member J L Newman, General Member Decision: See Appendix A Catchwords: CLINICAL TRIAL - Phase II trial - COVID-19 - pandemic - COVID-19 Acute Respiratory Distress Syndrome Requiring Intensive Care - new medication - whether the Tribunal should allow the use of human subjects who are unable to give their own consent to participation in the clinical trial - whether clincal trial meets criteria in 45AA of the Guardianship Act - safety and ethical considerations - whether it is in the best interests of patients that they take part in the clinical trial - no disease specific treatment available - clinical trial approved under s s 45AA(1) of the Guardianship Act. Legislation Cited: Guardianship Act 1987 (NSW), ss 4, 33(2), 34(1), 40, 45AA, 45AA(1)-(2), 45AB(1), 45AB(1)(a), 45AB(2); Part 5; Divs 3-4 Cases Cited: Shehabi v Attorney General (NSW) [2016] NSWCATAP 137 Texts Cited: Nil Category: Principal judgment Parties: Professor Anders Aneman (Applicant) Representation: Counsel: N/A

Solicitors: N/A File Number(s): NCAT 2020/00122652 Publication restriction: Decisions of the Guardianship Division of the Civil and Administrative Tribunal have been anonymised to remove any information that may identify any person involved in the Tribunal's proceedings: Civil and Administrative Tribunal Act 2013 (NSW), s 65.