CTRI/2020/12/029793
Trial name or title	Efficacy and safety of tocilizumab in patients with severe COVID‐19 pneumonia on steroid therapy: a prospective, randomized, double blind placebo‐controlled trial
Methods	RCT, placebo‐controlled, blind‐label study Date of study: December 2020 Location: India Phase 3
Participants	Randomised: 54 participants Inclusion criteria Patients 18 years or older Diagnosis of SARS‐CoV‐2 infection by RT‐PCR Pulmonary infiltrates on CXR/ CECT Chest On COVID specific steroid therapy with IV methyl prednisolone 1 mg/kg/day or dexamethasone 6 mg per day Severe respiratory failure with PaO2 / FiO2 less than 150 mmHg and IL‐6 > 50 pg/mL with CRP > 50 mg/L Signature of informed consent by the patient, family member or legal representative Exclusion criteria Less than 24 hours of initiation of steroid therapy Liver injury or failure (AST/ALT ≥ 5 x upper limit of normal) Leukocytes < 2 × 103/μl Thrombocytes < 50 × 103/μl Severe bacterial infection (procalcitonin > 3ng/mL) Acute or chronic diverticulitis Immunosuppressive therapy (e.g. mycophenolate, azathioprine, methotrexate and biologicals) Known active or chronic tuberculosis Known active or chronic viral hepatitis Known allergic reactions to tocilizumab or its ingredients
Interventions	Intervention: tocilizumab (IV, single dose, 8 mg/kg body weight) Control interventions: placebo
Outcomes	Primary outcome Secondary outcomes Mortality (28 days) Time to clinical improvement (28 days) Change of ventilation mode and invasiveness · Change of ventilation mode and invasiveness
Starting date	Study start date: 31 December 2020
Contact information	Nehru Hospital, Naveen Naik, navin_amc@yahoo.com
Notes	Registered but not recruiting