Corona Virus Infection, Critical Illness, Cytokine Release Syndrome
Conditions
Brief summary
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
Detailed description
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
Interventions
DRUGInterleukin 6 (IL6) Antagonist
anti-IL6 alone
DRUGInterleukin 6 (IL6) Antagonist and corticosteroids
anti-IL6 + corticosteroid combination
DRUGcorticosteroid alone
dexamethasone, hydrocortisone, methylprednisolone, prednisone. All steroids other than dexamethasone will be converted to dexamethasone equivalent
Sponsors
Society of Critical Care Medicine
King Faisal Specialist Hospital & Research Center
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult Critically ill patients 2. COVID-19 PCR positive 3. Presence of clinical and radiological signs of progressive disease, and laboratory evidence indicative of risk for cytokine storm complications. 4. Received anti-IL6 or corticosteroids as part of COVID-19 treatment
Exclusion criteria
1. Non COVID-19 related admissions 2. Repeated Admission to ICUs/Hospital 3. Patient did not receive anti-IL6 or corticosteroids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-Free Days | Up to Day 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median change in the PaO2/FiO2 | Up to Day 28 | Ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2) |
| Vasopressor-Free days | Up to Day 28 | 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. |
| Duration of ICU Stay | Up to 28 days | To compare ICU LOS |
| Duration of Hospital Stay | Up to 28 days | To compare hospital LOS |
| Median duration of ventilation | Up to Day 28 | From Intubation to extubation date and off Mechanical Ventilation or until ICU discharge, death, or 28 days whichever occurs first. |
| Percentage of participants with adverse events [transaminitis, hyperglycemia] | Up to 28 days | adverse events that occurs during 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 | Up to 28 days | Concentration of inflammatory markers |
| Rate of superinfection (bacterial, viral, invasive fungal infections) | Up to 28 days | — |
| Time to the first COVID 19 test negative | Up to 28 days | — |
| Mortality Rate | Up to Day 28 | Death that occurs during 28 days |
Countries
Saudi Arabia
Contacts
Primary ContactMarwa Amer, PharmD,BCPS, BCCCP
Backup ContactMohammed Bawazeer, MD,FRCSC,FACS
Outcome results
None listed