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

NCT ID: NCT05133635

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-04-01

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.

Detailed Description

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Conditions

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COVID-19 Virus Infection Cytokine Storm Corticosteroid Tocilizumab

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pulse methylprednisolone

250 mg methylprednisolone for 3 days

Group Type ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type DRUG

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

Tocilizumab

Tocilizumab 400-800 mg for one time

Group Type ACTIVE_COMPARATOR

Tocilizumab

Intervention Type DRUG

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

Interventions

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Methylprednisolone

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

Intervention Type DRUG

Tocilizumab

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

Intervention Type DRUG

Other Intervention Names

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Corticosteroid

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Ruslan Abdullayev

Assist. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ruslan Abdullayev

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Other Identifiers

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Steroid/Toci COVID-19

Identifier Type: -

Identifier Source: org_study_id