NCT04412772
Trial name or title	A RCT ‐ safety & efficacy of tocilizumab ‐ Tx of severe COVID‐19: ARCHITECTS
Methods	RCT, placebo‐controlled, double‐blind study Date of study: June 2020 Location: USA Phase 3
Participants	Randomised: 300 participants Inclusion criteria Hospitalised with COVID‐19 pneumonia, based on chest X‐ray or CT scan; AND Evidence of hyperinflammation: IL‐6 > 40pg/mL (if available);OR CRP > 2 mg/dL; OR Ferritin > 2000 ng/mL AND iv. 1 or more of the following: impending need for requiring invasive or non‐invasive mechanical ventilation; OR shock requiring vasopressor (without evidence of bacterial / fungal infection); OR need for ECMO; OR severe, refractor ARDS (PaO2/FiO2< 200 mmHg). Exclusion criteria Active tuberculosis infection based on history Suspected active bacterial, fungal, viral, or other infection (besides COVID‐19) In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments Have received oral anti‐rejection or immunomodulatory drugs (including tocilizumab) with the past 6 months Participating in other drug clinical trials (participation in COVID‐19 trials allowed) Self‐reported pregnant or breastfeeding Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study ALT or AST > 10 x ULN detected within 24 hours at baseline ANC < 1000/mL at baseline Platelet count < 50,000/mL at baseline
Interventions	Intervention: tocilizumab (IV, 8 mg/kg for up to max 800 mg, single infusion, 1 additional dose may be given if clinical symptoms worsen) Control interventions: placebo
Outcomes	Primary outcome Clinical status on a 7‐point ordinal scale (up to day 28) Secondary outcomes Clinical improvement (up to day 28) Mechanical ventilation (up to day 28)
Starting date	Study start date: 12 June 2020
Contact information	Queen's Medical Centre, Todd Seto, tseto@queens.org
Notes	Ongoing