NCT05133635

High-Dose Corticosteroid or Tocilizumab for Clinical Worsening of COVID-19

Comparison of the Treatment Efficacy of High-Dose Corticosteroid and Tocilizumab During Clinical Worsening in Patients With COVID-19 Pneumonia

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Marmara University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

COVID-19 pandemic has spread all over the world, and hospitalization of the patients with COVİD-19 Pneumonia has become a great burden to the Intensive Care Units. Unfortunately there is still no curative method for the disease yet. Intensive Care Units provide general care for the patients; including oxygen therapy, maintenance of the organ systems (e.g., cardiovascular, renal), nutrition, antibiotic therapy for secondary infections, and etc. One of the major problems in COVID-19 is macrophage activation syndrome, also known as cytokine storm. It stems from exaggerated inflammatory response, which causes increased cytokine release and results in clinical deterioration of the patients. Many drugs have been used to prevent this exaggerated inflammation, like corticosteroids, interleukin (IL) receptor blockers, plasma exchange, etc. In this study our aim is to investigate the effectiveness of high dose corticosteroid (methylprednisolone 250 mg for 3 days) and an IL-6 receptor antagonist (tocilizumab) in the treatment of the cytokine storm of the COVID-19 patients.

Conditions

• COVID-19 Virus Infection
• Cytokine Storm
• Corticosteroid
• Tocilizumab

Interventions

Type	Name	Description
DRUG	Methylprednisolone	Patients with the clinical and laboratory diagnosis of cytokine storm will receive methylprednisolone 250 mg for 3 days.
DRUG	Tocilizumab	Patients with the clinical and laboratory diagnosis of cytokine storm will receive tocilizumab 400-800 mg for one time.

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2021-11-24
• Last updated: 2021-11-24