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| Name | Class |
|---|---|
| Society of Critical Care Medicine | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | anti-IL-6 drugs (tocilizumab and siltuximab) |
| |
| Active Comparator 1 | Anti-IL-6 drugs (tocilizumab and siltuximab) and corticosteroids combination |
| |
| Active Comparator 2 | corticosteroids alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interleukin 6 (IL6) Antagonist | Drug | anti-IL6 alone |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator-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. | Up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Median duration of ventilation | From Intubation to extubation date and off Mechanical Ventilation or until ICU discharge, death, or 28 days whichever occurs first. | Up to Day 28 |
| Median change in the PaO2/FiO2 |
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Inclusion Criteria:
Exclusion Criteria:
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Data elements will be retrieved from Viral Infection and Respiratory Illness Universal Study: COVID-19 (VIRUS registry ClinicalTrials.gov Identifier: NCT04323787) which is a prospective, non-interventional, multi-center, multi-national observational cross sectional study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marwa Amer, PharmD,BCPS, BCCCP | Contact | +966114647272 | mamer@kfshrc.edu.sa | |
| Mohammed Bawazeer, MD,FRCSC,FACS | Contact | +966112162919 | mbawazeer@kfshrc.edu.sa |
| Name | Affiliation | Role |
|---|---|---|
| Marwa Amer, PharmD,BCPS, BCCCP | King Faisal Specialist Hospital and Research Center- Riyadh | Principal Investigator |
| Mohammed Bawazeer, MD,FRCSC,FACS | King Faisal Specialist Hospital and Research Center- Riyadh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Faisal Specialist Hospital and Research Center | Recruiting | Riyadh | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32426754 | Background | Walkey AJ, Kumar VK, Harhay MO, Bolesta S, Bansal V, Gajic O, Kashyap R. The Viral Infection and Respiratory Illness Universal Study (VIRUS): An International Registry of Coronavirus 2019-Related Critical Illness. Crit Care Explor. 2020 Apr 29;2(4):e0113. doi: 10.1097/CCE.0000000000000113. eCollection 2020 Apr. | |
| 34600589 | Derived |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D018352 | Coronavirus Infections |
| D000080424 | Cytokine Release Syndrome |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003333 | Coronaviridae Infections |
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| ID | Term |
|---|---|
| D015850 | Interleukin-6 |
| C502936 | tocilizumab |
| C504234 | siltuximab |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| Interleukin 6 (IL6) Antagonist and corticosteroids | Drug | anti-IL6 + corticosteroid combination |
|
| corticosteroid alone | Drug | dexamethasone, hydrocortisone, methylprednisolone, prednisone. All steroids " other than dexamethasone" will be converted to dexamethasone equivalent |
|
Ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2)
| 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. | Up to Day 28 |
| Duration of ICU Stay | To compare ICU LOS | Up to 28 days |
| Duration of Hospital Stay | To compare hospital LOS | Up to 28 days |
| Mortality Rate | Death that occurs during 28 days | Up to Day 28 |
| Percentage of participants with adverse events [transaminitis, hyperglycemia] | adverse events that occurs during 28 days | 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 | Up to 28 days |
| Rate of superinfection (bacterial, viral, invasive fungal infections) | Up to 28 days |
| Time to the first COVID 19 test negative | Up to 28 days |
| Amer M, Kamel AM, Bawazeer M, Maghrabi K, Butt A, Dahhan T, Kseibi E, Khurshid SM, Abujazar M, Alghunaim R, Rabee M, Abualkhair M, Al-Janoubi A, AlFirm AT, Gajic O, Walkey AJ, Mosier JM, Zabolotskikh IB, Gavidia OY, Teruel SY, Bernstein MA, Boman K, Kumar VK, Bansal V, Kashyap R; Society of Critical Care Medicine Discovery Viral Infection and Respiratory Illness Universal Study (VIRUS): COVID-19 Registry Investigator Group. Clinical characteristics and outcomes of critically ill mechanically ventilated COVID-19 patients receiving interleukin-6 receptor antagonists and corticosteroid therapy: a preliminary report from a multinational registry. Eur J Med Res. 2021 Oct 2;26(1):117. doi: 10.1186/s40001-021-00591-x. |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D012769 | Shock |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |