Corticosteroid, COVID-19 Virus Infection, Cytokine Storm, Tocilizumab
Conditions
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.
Interventions
DRUGMethylprednisolone
Patients with the clinical and laboratory diagnosis of cytokine storm will receive methylprednisolone 250 mg for 3 days.
DRUGTocilizumab
Patients with the clinical and laboratory diagnosis of cytokine storm will receive tocilizumab 400-800 mg for one time.
Sponsors
Marmara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed