NCT04345445.

Study name	Study to evaluate the efficacy and safety of tocilizumab versus corticosteroids in hospitalised COVID‐19 patients with high risk of progression
Methods	Trial design: open‐label, randomised, cross‐over interventional study Sample size: 310 Setting: inpatient Language: English Number of centres: 4 Type of intervention (treatment/prevention): treatment
Participants	Inclusion criteria Hospitalised symptomatic COVID‐19 patients Presence of clinical and radiological signs of progressive disease, AND laboratory evidence indicative of risk of cytokine storm complications: Clinical: dyspnoea or respiratory rate > 20 breaths/min AND O2 saturation < 93% on room air or increasing need for O2 supplementation to maintain O2 saturation > 95% on room air, WITH Radiological: chest X‐ray or CT indicative of pneumonia or worsening findings over time AND Laboratory: CRP levels > 60 or an increase of CRP > 20 over 12 h, WITH an increasing ferritin level or declining lymphocyte counts Age > 18 years Able to give consent Exclusion criteria Known sensitivity/allergy to tocilizumab or other monoclonal antibodies AST/ALT > 5 times ULN Platelet counts < 50,000 or neutrophil counts < 500 Active TB Pregnant Receipt of mechanical ventilation Has received other immunomodulatory drugs (including tocilizumab) in the past for the treatment of other conditions Individuals, in the opinion of the investigator, where progression to death is imminent and inevitable in the next 24 h irrespective of treatment provision or who have signed a do not resuscitate order Participating in other clinical trials (subject to approval) Any serious medical condition or abnormal clinical laboratory tests which, in the judgement of the investigator, may compromise patient safety should he/she participate in the study
Interventions	Details of intervention Dose: 8 mg/kg (body weight) tocilizumab Route of administration: IV Treatment details of control group (e.g. dose, route of administration): methylprednisolone 120 mg/day for 3 days IV Concomitant therapy: no information
Outcomes	Primary study outcome The proportion of patients requiring mechanical ventilation (time frame: through study completion, and average of 6 months) Mean days of ventilation (time frame: through study completion, and average of 6 months)
Starting date	14 April 2020
Contact information	Adeeba Kamarulzaman, MBBS: +603‐79492050 Email: adeeba@um.edu.my
Notes	Recruitment status: not yet recruiting Prospective completion date: 31 October 2020 Date last update was posted: 14 April 2020 Sponsor/funding: University of Malaya