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 moderate COVID-19 disease at risk for complications of cytokine storm. Approximately 310 participants hospitalized with COVID-19 in UMMC, Hospital Sungai Buloh, Hospital Kuala Lumpur and Hospital Tuanku Jaafar will be enrolled into this study. Eligible participants will be selected based on a set of clinical, laboratory and radiological parameters indicative of early stages of CRS and lung function decline prior to being randomized at a ratio of 1:1 to receive either Tocilizumab or Methylprednisolone. Participants will be monitored daily for clinical and laboratory parameters, and at 48 hours, switched to the alternate study arm should they manifest signs and symptoms indicative of decompensation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
310
IV infusion
IV infusion
University Malaya Medical Centre
Kuala Lumpur, Malaysia
The proportion of patients requiring mechanical ventilation
Time frame: Through study completion, and average of 6 months
Mean days of ventilation
Time frame: Through study completion, and average of 6 months
The proportion of patients requiring ICU admission
Time frame: Through study completion, and average of 6 months
Overall 28-day survival
Time frame: 28 day from baseline
Change in symptom severity assessed by the World Health Organization (WHO) Coronavirus Disease 2019 (COVID19) ordinal scale measured daily up to 7 days from baseline
Time frame: 7 days from baseline
Duration of hospital and ICU stay
Time frame: Through study completion, and average of 6 months
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