Study to Evaluate the Efficacy and Safety of Tocilizumab Versus Corticosteroids in Hospitalised COVID-19 Patients With High Risk of Progression

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19 Read More

Inclusion Criteria:

1) Hospitalised symptomatic COVID-19 patients 2( Presence of clinical and radiological signs of progressive disease, AND laboratory evidence indicative of risk for cytokine storm complications.

All patients participating in this clinical trial must meet the following inclusion criteria:

1. Hospitalised symptomatic COVID-19 patients

2. Presence of clinical and radiological signs of progressive disease, AND laboratory evidence indicative of risk for cytokine storm complications:

   Clinical:

   Dyspnoea OR RR>20 breaths/min AND O2 sat <93% on RA OR increasing need for O2 supplementation to maintain O2 sat >95% on RA

   WITH

   Radiological:

   CXR or CT indicative of pneumonia OR worsening findings over time

   AND

   Laboratory:

   CRP levels >60 OR an increase of CRP >20 over 12 hours WITH an increasing ferritin level OR declining lymphocyte counts

3. Age > 18 years and able to give consent

Exclusion Criteria:

Patients will be excluded if any of the following conditions apply:

1. Known sensitivity/allergy to TCZ or other monoclonal antibodies
2. AST/ALT>5 times UNL, platelet counts <50,000 or neutrophil counts <500
3. Active TB
4. Pregnant
5. Receipt of mechanical ventilation
6. Has received other immunomodulatory drugs (including TCZ) in the past for the treatment of other conditions
7. Individuals, in the opinion of the investigator, where progression to death is imminent and inevitable in the next 24 hours irrespective of treatment provision or who have signed a DNR.
8. Participating in other clinical trials (subject to approval)
9. 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.