Status:
UNKNOWN
Study to Evaluate the Efficacy and Safety of Tocilizumab Versus Corticosteroids in Hospitalised COVID-19 Patients With High Risk of Progression
Lead Sponsor:
University of Malaya
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study aims to compare the efficacy and safety of Methylprednisolone versus Tocilizumab in improving clinical outcomes and reducing the need for ventilator support in COVID-19 patients with modera...
Eligibility Criteria
Inclusion
- 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:
- Hospitalised symptomatic COVID-19 patients
- 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
- Age \> 18 years and able to give consent
Exclusion
- Patients will be excluded if any of the following conditions apply:
- Known sensitivity/allergy to TCZ or other monoclonal antibodies
- AST/ALT\>5 times UNL, platelet counts \<50,000 or neutrophil counts \<500
- Active TB
- Pregnant
- Receipt of mechanical ventilation
- Has received other immunomodulatory drugs (including TCZ) in the past for the treatment of other conditions
- 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.
- Participating in other clinical trials (subject to approval)
- 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.
Key Trial Info
Start Date :
April 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2020
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT04345445
Start Date
April 15 2020
End Date
October 31 2020
Last Update
April 14 2020
Active Locations (1)
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1
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100