ACTRN12620000580976
Trial name or title	Tocilizumab for the treatment of COVID‐19 in intensive care patients: effect on days free of ventilatory support
Methods	RCT, active‐controlled, open‐label study Date of study: April 2020 Location: Australia Phase 1/2
Participants	Randomised: 150 participants Inclusion criteria Male or female aged greater than or equal to 18 years Confirmed SARS‐CoV‐2 by PCR with sample taken within 14 days prior to randomisation 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) Enrolled prior to or within 24 hours of ICU admission Exclusion criteria Absolute neutrophil count less than 0.5 x 10e9/Litre, platelets less than 50 x 10e9/Litre Previous TNFa antagonist treatment within the last 3 months Confirmed bacterial sepsis or untreated bacterial, mycobacterial or fungal infection Untreated hepatitis B virus infection Recent major surgery within the last 8 weeks Organ transplant recipients Primary or secondary immunodeficiency History of diverticulitis, inflammatory bowel disease, or other symptomatic gastrointestinal condition that might predispose to bowel perforation Known cirrhosis or aminotransferases greater than 5 times upper limit of normal Pregnant or breastfeeding Known allergy or hypersensitivity to TCZ or other monoclonal antibodies Previous participation in the trial Patient being treated with palliative intent, or not expected to be alive in 48 hours
Interventions	Intervention: tocilizumab (IV, 400 mg, single dose) Control intervention: standard of care
Outcomes	Primary outcome Secondary outcomes Mortality (daily up to day 29) Adverse events (daily up to day 29)
Starting date	Study start date: 19 October 2020
Contact information	QIMR Berghofer Medical Research Institute, Bridget Barber, +61733620104, bridget.barber@qimrberghofer.edu.au
Notes	Registered but not recruiting