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

Marmara University

Status and phase: Withdrawn; Phase 4

Conditions: Corticosteroid; Tocilizumab; Cytokine Storm; COVID-19 Virus Infection

Treatments: Drug: Tocilizumab; Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT05133635

Steroid/Toci COVID-19

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with COVID-19 Pneumonia treated in the Intensive Care Unit
• Clinical deterioration during intensive care follow-up
• First 14 days from the COVID-19 diagnosis

Exclusion criteria

• More than 14 days passed from the COVID-19 diagnosis
• Clinical and laboratory signs of secondary bacterial infection

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Pulse methylprednisolone

Active Comparator group

Description:

250 mg methylprednisolone for 3 days

Treatment:

Drug: Methylprednisolone

Tocilizumab

Active Comparator group

Description:

Tocilizumab 400-800 mg for one time

Treatment:

Drug: Tocilizumab