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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05133635
Other study ID # Steroid/Toci COVID-19
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
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
Health authority
Study type Interventional

Clinical Trial Summary

COVID-19 pandemic has spread all over the world, and hospitalization of the patients with COVÄ°D-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Status Withdrawn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

Study Design


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
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