The cytokine storms mediated by over production of proinflammatory cytokines have been observed in a large population of critically ill patients infected with COVID-19. Patients diagnosed with cytokine storms progress to cardiovascular collapse, multiple organ dysfunction and death rapidly. Therefore, early identification, treatment and prevention of the cytokine storms are of crucial importance for the patients. Immuomedulator such as interleukin-6 (IL-6) antagonist, emerged as an alternative treatment for COVID-19 patients with a risk of cytokine storms recently. In this study, we aimed to evaluate the safety and efficacy of anti-IL6 alone vs anti-IL6 corticosteroid combination in patients with COVID-19 pneumonia
This study will provide further insight whether anti-IL6 alone provide same efficacy and clinical outcome with reasonable side effects profile compared to anti-IL6 + corticosteroid and might serve as a corticosteroid sparing agents in COVID-19 patient with cytokine storms. Data elements will be retrieved from VIRUS registry which is a prospective, non-interventional, multi-center, multi-national observational cross sectional study
Study Type
OBSERVATIONAL
Enrollment
860
anti-IL6 alone
anti-IL6 + corticosteroid combination
dexamethasone, hydrocortisone, methylprednisolone, prednisone. All steroids " other than dexamethasone" will be converted to dexamethasone equivalent
King Faisal Specialist Hospital and Research Center
Riyadh, Saudi Arabia
RECRUITINGVentilator-Free Days
The median ventilator-free days will be calculated as calendar days with no ventilator support to day 28 . Participants who die before day 28 are assigned zero free days.
Time frame: Up to Day 28
Median duration of ventilation
From Intubation to extubation date and off Mechanical Ventilation or until ICU discharge, death, or 28 days whichever occurs first.
Time frame: Up to Day 28
Median change in the PaO2/FiO2
Ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2)
Time frame: Up to Day 28
Vasopressor-Free days
The median vasopressor-free days will be calculated as calendar days with no vasopressor support to day 28. Participants who die before day 28 are assigned zero free days.
Time frame: Up to Day 28
Duration of ICU Stay
To compare ICU LOS
Time frame: Up to 28 days
Duration of Hospital Stay
To compare hospital LOS
Time frame: Up to 28 days
Mortality Rate
Death that occurs during 28 days
Time frame: Up to Day 28
Percentage of participants with adverse events [transaminitis, hyperglycemia]
adverse events that occurs during 28 days
Time frame: Up to 28 days
Concentration of Ferritin, IL6, D dimer, fibrinogen, C-reactive protein (CRP), Lactate dehydrogenase (LDH) and absolute lymphocyte count and their correlation with the effectiveness of the treatment
Concentration of inflammatory markers
Time frame: Up to 28 days
Rate of superinfection (bacterial, viral, invasive fungal infections)
Time frame: Up to 28 days
Time to the first COVID 19 test negative
Time frame: Up to 28 days
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