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

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID-19 Virus Infection, Cytokine Storm, Corticosteroid, Tocilizumab

Intervention / Treatment
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* Drug: Methylprednisolone
* Drug: Tocilizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulse methylprednisolone<br>250 mg methylprednisolone for 3 days | Drug: Methylprednisolone<br>* Patients with the clinical and laboratory diagnosis of cytokine storm will receive methylprednisolone 250 mg for 3 days.<br>* Other names: Corticosteroid;|
| Active Comparator: Tocilizumab<br>Tocilizumab 400-800 mg for one time | Drug: Tocilizumab<br>* Patients with the clinical and laboratory diagnosis of cytokine storm will receive tocilizumab 400-800 mg for one time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical condition | Arterial oxygen partial pressure of the patient will be observed. | Next 7 days of the intervention. | 
| Blood analysis | Acute phase reactants (C-reactive protein, procalcitonin, ferritin, fibrinogen), will be investigated. | Next 7 days of the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | Hospital stay period of the patients will be observed. | Until the hospital discharge. | 
| Mortality | Mortality of the patients will be observed. | Not relevant |