NCT04345445

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

An Open-label, Randomized, Cross-over Interventional Study to Evaluate the Efficacy and Safety of Tocilizumab Versus Corticosteroids in Hospitalised COVID-19 Patients With High Risk of Progression

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 310 (estimated)
• Sponsor: University of Malaya · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Tocilizumab	IV infusion
DRUG	Methylprednisolone	IV infusion

Timeline

• Start date: 2020-04-15
• Primary completion: 2020-10-31
• Completion: 2020-10-31
• First posted: 2020-04-14
• Last updated: 2020-04-14

Locations

1 site across 1 country: Malaysia