Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A recent study suggested a new corticosteroid regime for intensive care unit patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulse methylprednisolone | Active Comparator | 250 mg methylprednisolone for 3 days |
|
| Tocilizumab | Active Comparator | Tocilizumab 400-800 mg for one time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | Patients with the clinical and laboratory diagnosis of cytokine storm will receive methylprednisolone 250 mg for 3 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital stay | Hospital stay period of the patients will be observed. | Until the hospital discharge. |
| Mortality | Mortality of the patients will be observed. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ruslan Abdullayev | Marmara University | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000080424 | Cytokine Release Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D000305 | Adrenal Cortex Hormones |
| C502936 | tocilizumab |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Tocilizumab | Drug | Patients with the clinical and laboratory diagnosis of cytokine storm will receive tocilizumab 400-800 mg for one time. |
|
| Not relevant |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |