COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12620000588998.aspx

Prof Anders Aneman

anders.aneman@health.nsw.gov.au

2020-05-21

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

Subjects entering the ICU and presenting with confirmed or suspected COVID-19-related ARDS will be enrolled in the trial. 1. Aged 18 to 80 years (inclusive at the time of consent) 2. Subjects are diagnosed with moderate to severe ARDS that has been present for less than 3 days 3. Meet Berlin Definition 1) Must have a partial pressure of arterial O2 (PaO2)/ fraction of inspired O2 (FiO2) less than or equal to 200 mmHg on invasive or non-invasive ventilation with the level of positive end-expiratory pressure (PEEP) or continuous positive pressure (CPAP) greater than or equal to 5cmH2O. 2) Bilateral opacities not fully explained by effusion, lobar or lung collapse, or nodules by chest X-ray or CT 3) Respiratory failure not fully explained by heart failure or fluid overload In the opinion of the treating clinicians, likely to survive beyond the day after tomorrow. 4. Subjects who are consented

1. Subjects who have <55 ml/min/BSA 2. Subjects who require ECMO 3. Subjects who require a therapeutic dose of heparin or who are receiving oral anticoagulants, or received warfarin, factor Xa inhibitors within last 24 hours 4. Subjects who have Absolute Neutrophil Count (ANC) <1000/mL, 6. Subjects who have activated Partial Thromboplastin Time (aPTT) >55 s, 7. Severe anaemia (haemoglobin, 8. Bleeding in the past 24 hours requiring blood transfusion, 9. Subjects who have the following chronic organ dysfunction or immunosuppression

2

Grand Medical Pty Ltd

18

80

Australia

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

160

Incidence of treatment discontinuation due to AEs [D10 in stage 1];Incidence; nature and severity of AEs and SAEs[D10 in stage 1];Changes in PaO2/FiO2 assessed by arterial blood gases and ventilator measures[end of infusion in stage 2]

Phase 2

[{"arm_notes": "", "treatment_id": 1237, "treatment_name": "Stc3141", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]