COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12620000517976.aspx

Barry Dixon

barry.dixon@svha.org.au

2020-04-27

Recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

Age 18 years or older In ICU or scheduled for transfer to ICU Endotracheal tube in place Intubated yesterday or today PaO2 to FIO2 ratio less than or equal to 300 while intubated Acute opacities not fully explained by effusions, lobar/lung collapse and nodules, affecting at least one lung quadrant on chest X-ray or CT The acute opacities on chest X-ray or CT are most likely due to COVID-19 There is a PCR positive sample for SARS-CoV-2 within the past 21 days or there are results pending or further testing is planned

Enrolled in another clinical trial that is unapproved for co-enrolment Heparin allergy or heparin-induced thrombocytopaenia APTT > 120 seconds and this is not due to anticoagulant therapy Platelet count < 20 x 10^9 per L Pulmonary bleeding Uncontrolled bleeding Pregnant or might be pregnant Receiving or about to commence ECMO or HFOV Myopathy, spinal cord injury, or nerve injury or disease with a likely prolonged incapacity to breathe independently e.g. Guillain-Barre syndrome Acute brain injury that may result in long-term disability Usually receives home oxygen Dependent on others for personal care due to physical or cognitive decline Death is imminent or inevitable within 24 hours The clinical team would not be able to set up the study nebuliser and ventilator circuit as required including with active humidification Clinician objection

2

St Vincents Hospital Melbourne

18

100

Australia

Critical disease at enrollment

8: Critical disease at enrollment

206

Time to separation from invasive ventilation; censored at Day 28; with non-survivors treated as though never separated from the ventilator. This will be assessed from review of the medical records. [Day 28]

Phase 3

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