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

Cytokine Storm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05133635
• Other study ID #: Steroid/Toci COVID-19
• Status: Withdrawn
• Phase: Phase 4
• Start date: February 1, 2021
• Est. completion date: April 1, 2021

Study information

• Verified date: November 2021
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Corticosteroid
• COVID-19
• COVID-19 Virus Infection
• Cytokine Release Syndrome
• Cytokine Storm
• Tocilizumab

Intervention

Drug:
• Methylprednisolone
Patients with the clinical and laboratory diagnosis of cytokine storm will receive methylprednisolone 250 mg for 3 days.
• Tocilizumab
Patients with the clinical and laboratory diagnosis of cytokine storm will receive tocilizumab 400-800 mg for one time.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical condition	Arterial oxygen partial pressure of the patient will be observed.	Next 7 days of the intervention.
Primary	Blood analysis	Acute phase reactants (C-reactive protein, procalcitonin, ferritin, fibrinogen), will be investigated.	Next 7 days of the intervention.
Secondary	Hospital stay	Hospital stay period of the patients will be observed.	Until the hospital discharge.
Secondary	Mortality	Mortality of the patients will be observed.	Not relevant