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

Sponsor

Marmara University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT05133635

Collaborator

(none)

Enrollment

Arms

1.9

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Virus Infection Cytokine Storm Corticosteroid Tocilizumab	Drug: Methylprednisolone Drug: Tocilizumab	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 1, 2021

Actual Primary Completion Date :

Apr 1, 2021

Actual Study Completion Date :

Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pulse methylprednisolone 250 mg methylprednisolone for 3 days	Drug: Methylprednisolone Patients with the clinical and laboratory diagnosis of cytokine storm will receive methylprednisolone 250 mg for 3 days. Other Names: Corticosteroid
Active Comparator: Tocilizumab Tocilizumab 400-800 mg for one time	Drug: Tocilizumab Patients with the clinical and laboratory diagnosis of cytokine storm will receive tocilizumab 400-800 mg for one time.

Arm

Intervention/Treatment

Active Comparator: Pulse methylprednisolone

250 mg methylprednisolone for 3 days

Drug: Methylprednisolone

Patients with the clinical and laboratory diagnosis of cytokine storm will receive methylprednisolone 250 mg for 3 days.

Other Names:

Corticosteroid

Active Comparator: Tocilizumab

Tocilizumab 400-800 mg for one time

Drug: Tocilizumab

Patients with the clinical and laboratory diagnosis of cytokine storm will receive tocilizumab 400-800 mg for one time.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Hospital stay [Until the hospital discharge.]
Hospital stay period of the patients will be observed.
Mortality [Not relevant]
Mortality of the patients will be observed.