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

NCT05133635 | Withdrawn Phase 4

• 1 other identifier: Steroid/Toci COVID-19
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Hospital stay

  Until the hospital discharge.

• Mortality

  Not relevant

Study Arms (2)

Pulse methylprednisolone

ACTIVE COMPARATOR

250 mg methylprednisolone for 3 days

Drug: Methylprednisolone

Tocilizumab

ACTIVE COMPARATOR

Tocilizumab 400-800 mg for one time

Drug: Tocilizumab

Interventions

Methylprednisolone DRUG

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

Also known as: Corticosteroid

Pulse methylprednisolone

Tocilizumab DRUG

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

Tocilizumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University: lead

MeSH Terms

Conditions

COVID-19; Cytokine Release Syndrome

Interventions

Methylprednisolone; Adrenal Cortex Hormones; tocilizumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Ruslan Abdullayev

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: November 24, 2021
• Study Start: February 1, 2021
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share