COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12620000580976.aspx

Prof Bridget Barber

bridget.barber@qimrberghofer.edu.au

2020-05-19

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Male or female aged greater than or equal to 18 years 2. Confirmed SARS-CoV-2 by PCR with sample taken within 14 days prior to randomisation 3. Requirement for invasive or non-invasive ventilatory support or admission to ICU (or planned commencement of invasive or non-invasive ventilatory support, or planned admission to ICU) 4. Enrolled prior to or within 24 hours of ICU admission

1. Absolute neutrophil count less than 0.5x10e9/Litre, platelets less than 50x10e9/Litre 2. Previous TNF alpha antagonist treatment within the last 3 months 3. Confirmed bacterial sepsis or untreated bacterial, mycobacterial or fungal infection 4. Untreated hepatitis B virus infection 5. Recent major surgery within the last 8 weeks 6. Organ transplant recipients 7. Primary or secondary immunodeficiency 8. History of diverticulitis, inflammatory bowel disease, or other symptomatic gastrointestinal condition that might predispose to bowel perforation 9. Known cirrhosis or aminotransferases greater than 5 times upper limit of normal 10. Pregnant or breastfeeding 11. Known allergy or hypersensitivity to TCZ or other monoclonal antibodies 12. Previous participation in the trial 13. Patient being treated with palliative intent, or not expected to be alive in 48 hours

2

QIMR Berghofer Medical Research Institute

18

100

Australia

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

150

The number of days alive and free of ventilatory support as a composite outcome determined by data from patient records.[up to day Day 29]

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]