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
Verified date | November 2021 |
Source | Marmara University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Marmara University |
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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