Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Tocilizumab: Administration of 8mg/kg body weight (BW) Tocilizumab i.v. immediately after
randomisation (total dose should not exceed 800mg) (single dose will be administered after rand
Sponsors
Naveen Naik B
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients 18 years or older 2. Diagnosis of SARS-CoV-2 infection by RT-PCR 3. Pulmonary infiltrates on CXR/ CECT Chest 4. On COVID specific steroid therapy with IV methyl prednisolone 1 mg/kg/day or dexamethasone 6 mg per day 5. Severe respiratory failure with PaO2 / FiO2 less than 150 mmHg and IL-6 > 50 pg/mL with CRP > 50 mg/L 6. Signature of informed consent by the patient, family member or legal representative
Exclusion criteria
Exclusion criteria: 1.Less than 24 hrs of initiation of steroid therapy 2. Liver injury or failure (AST/ALT >= 5x Upper limit of normal) 3. Leukocytes 4. Thrombocytes 5. Severe bacterial infection (Procalcitonin > 3ng/ml) 6. Acute or chronic diverticulitis 7. Immunosuppressive therapy (e.g. mycophenolate, azathioprine, methotrexate and biologicals) 8. Known active or chronic tuberculosis 9. Known active or chronic viral hepatitis 10. Known allergic reactions to tocilizumab or its ingredients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ventilator free days (VFD) in the first 28 days, after randomisationTimepoint: 28 days after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 28-day mortality (%) Remission of respiratory symptoms Time to clinical improvement (Time frame: 28 days, after randomization) Days in ICU Invasive mechanical ventilation free days Change of ventilation mode and invasiveness Radiological response or improvement Levels of procalcitonin, CRP, IL-6, Ferritin and D-Dimers and their correlation with the treatment effectiveness Renal function SOFA-Score APACHE-II Score Duration of hospitalization Murray lung score 7 point scale Timepoint: ICU stay and 28 days after randomization | — |
Countries
India
Contacts
Public ContactNaveen Naik B
Post Graduate Institute of Medical Education and Research
Outcome results
None listed