TOCILIZUMAB - An Option for Patients With COVID-19 Associated Cytokine Release Syndrome; A Single Center Experience

Objectives: To analyze the effectiveness of Tocilizumab in moderate to severe Covid-19 participants on the basis of predefined assessment criteria.

Study Settings: Single center, Fatima Memorial Hospital, Lahore.

Study Design: Quasi experimental.

Duration of Study: From 12th May, 2020 to 12th July, 2020.

Participants & Methods: Sample size and technique: Sample size was 93; 33 participants were kept in experimental group, given Tocilizumab, 8mg/kg intravenously or 162 mg subcutaneously and rest of the 60 participants were given corticosteroids, methylprednisolone 80 mg/day. Consecutive sampling.

Failure of therapy was labeled when participants were intubated or died, and the endpoints were failure-free survival which was the primary endpoint and overall survival secondary at the time of discharge.

• Inclusion Criteria:

• All patients diagnosed with COVID-19 infection with positive reverse transcriptase RT-PCR test, willing to participate in this study or PCR negative patients with clinically COVID-19 Pneumonia in cytokine storm as evidenced by raised inflammatory markers with typical radiological changes
• Patients of both genders were included
• Patients having an age of > 65 years with proven Cardiomyopathy, Coronary artery disease, chronic lung disease, Immunosuppressed or organ transplant End-stage renal disease on history & examination and medical records and having any 1 out of 4 Fever 0f
• ≥39 C
• Hypotension or drop in mean arterial pressure of > 10mmHg
• Progressive Hypoxemia requiring > 5 liters of oxygen
• Sustained Respiratory rate >30/min with any 2 laboratory parameters out of 3 are present D-dimers ≥ 1000 ng/ml C-reactive protein CRP ≥ 100mg/L Ferritin ≥ 600ng/ml
• Patients having low risk or no comorbidities and having an age of <65 years with having any 3 out of 4 Fever 0f
• ≥39 C
• Hypotension or drop in mean arterial pressure of > 10mmHg
• Progressive Hypoxemia requiring > 5 liters of oxygen
• Sustained Respiratory rate >30/min With any 2 laboratory parameters out of 3 are present D-dimers ≥ 1000 ng/ml C-reactive protein CRP ≥ 100mg/L Ferritin ≥ 600ng/ml
• Moderate severe or severe COVID 19 features

• Shortness of breath oxygen saturation <93% on room air
• Progressive Hypoxemia requiring > 5 liters of oxygen
• Respiratory rate >30/min
• The partial pressure of arterial oxygen to fraction of inspired oxygen ratio<300
• Lung infiltrates on Chest x-ray CXR >50% within 24 to 48 hrs
• Respiratory failure
• Exclusion Criteria:

• Known severe allergic reactions to Tocilizumab or any other monoclonal antibody
• Pregnancy or breastfeeding
• Absolute Neutrophil Count(ANC) < 1000
• Alanine aminotransferase(ALT) or aspartate aminotransferase (AST) > 5 times upper normal limit
• Platelet count of < 50,000
• Bowel diverticulitis or bowel perforation
• Patients having Acute pancreatitis