Created at Source Raw Value Validated value
Oct. 26, 2020, 8:29 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Patients with confirmed severe SARS-CoV-2 infection will be screened and those that meet eligibility criteria; and who consented (or whose next of kin or guardian consent will be enrolled in the study. Patients will be randomized 2:1 on Day 1 to receive a single dose of 400 mg TCZ (Actemra\u00ae; Roche Products Pty Limited) administered intravenously over 1 h (in addition to standard of care); or standard of care alone. Standard of care will be determined by the treating clinician for each individual patient and will be in accordance with the evolving treatment guidelines for critically ill patients with COVID-19. Treatments may include antiviral agents (e.g. LPV/r; HCQ); or antibiotics (use adjunctive therapies such as steroids is discouraged but will be allowed if deemed necessary). Adherance to the intervention will be recorded in product accountability log and source data verification.Clinical data collection (ICU interventions including drug treatments; vital signs; adverse events) and safety blood sampling will be performed daily until day 29; ICU discharge; or death; whichever is earlier. If the participant is discharged from ICU but remains hospitalised; data will be collected daily until day 8 and also on Days 15 and Day 29. If the patient is discharged prior to Day 15 or Day 29; then a phone call will be made to ascertain clinical status. Blood sampling for immunological analyses; and chest imaging; will be performed at baseline and select timepoints during the study.We hypothesise that TCZ treatment in conjunction with standard of care will lead to a reduction in the number of days patients admitted to the ICU with severe SARS-CoV-2 infection require ventilatory support; compared with standard of care alone.A total of 150 patients are planned to b", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"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"}]