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

Sponsor
University of Malaya
Study ID
NCT04345445
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    IV infusion
  • Methylprednisolone — DRUG
    IV infusion

Study Details

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.

Key Dates

Start date
Apr 15, 2020
Status verified
Apr 2020
Primary completion
Oct 31, 2020
Completion
Oct 31, 2020

Study Design

Enrollment
310 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab
    Tocilizumab is given at 8 mg/kg (body weight) once and administered as an intravenous infusion within no less than 60 minutes.
  • Active Comparator: Methylprednisolone
    Reconstituted methylprednisolone is infused over 30 minutes and administered at a dose of 120mg/day for 3 days

Primary Outcome Measure

The proportion of patients requiring mechanical ventilation [ Time Frame: Through study completion, and average of 6 months ]

Central Contacts

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