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

Phase 4

Withdrawn

• Conditions: Cytokine Storm; Corticosteroid; Tocilizumab; COVID-19 Virus Infection
• Interventions: Drug: Methylprednisolone; Drug: Tocilizumab

• Registration Number: NCT05133635
• Lead Sponsor: Marmara University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-11
• Study Start: 2021-02-01
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-22
• Last Update Submitted: 2021-11-22
• Study First Posted: 2021-11-24
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulse methylprednisolone	Methylprednisolone	250 mg methylprednisolone for 3 days
Tocilizumab	Tocilizumab	Tocilizumab 400-800 mg for one time

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.