COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50303

Naveen Naik B

navin_amc@yahoo.com

2020-12-15

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

1. Patients 18 years or older <br/ >2. Diagnosis of SARS-CoV-2 infection by RT-PCR <br/ >3. Pulmonary infiltrates on CXR/ CECT Chest <br/ >4. On COVID specific steroid therapy with IV methyl prednisolone 1 mg/kg/day or dexamethasone 6 mg per day <br/ >5. Severe respiratory failure with PaO2 / FiO2 less than 150 mmHg and IL-6 > 50 pg/mL with CRP > 50 mg/L <br/ >6. Signature of informed consent by the patient, family member or legal representative <br/ >

1.Less than 24 hrs of initiation of steroid therapy <br/ >2. Liver injury or failure (AST/ALT � 5x Upper limit of normal) <br/ >3. Leukocytes < 2 � 103/μl <br/ >4. Thrombocytes < 50 � 103/μl <br/ >5. Severe bacterial infection (Procalcitonin > 3ng/ml) <br/ >6. Acute or chronic diverticulitis <br/ >7. Immunosuppressive therapy (e.g. mycophenolate, azathioprine, methotrexate and biologicals) <br/ >8. Known active or chronic tuberculosis <br/ >9. Known active or chronic viral hepatitis <br/ >10. Known allergic reactions to tocilizumab or its ingredients <br/ >

2

Naveen Naik B

18

90

India

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

54

Ventilator free days (VFD) in the first 28 days; after randomisationTimepoint: 28 days after randomisation

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]