Official Title
Clinical Outcome of Anti-IL6 and Corticosteroid Monotherapy vs Combination in COVID-19 Cytokine Release Syndrome
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

Unknown status
Critical Illness
Corona Virus Infection
Cytokine Release Syndrome

Drug: Interleukin 6 (IL6) Antagonist

anti-IL6 alone
Other Name: Array

Drug: Interleukin 6 (IL6) Antagonist and corticosteroids

anti-IL6 + corticosteroid combination

Drug: corticosteroid alone

dexamethasone, hydrocortisone, methylprednisolone, prednisone. All steroids " other than dexamethasone" will be converted to dexamethasone equivalent

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 14 Years ~ Maximum: N/A
Countries
Saudi Arabia
Locations

King Faisal Specialist Hospital and Research Center
Riyadh, Saudi Arabia

Investigator: Abeer Omar
ORA@kfshrc.edu.sa

Investigator:

Contacts

Marwa Amer, PharmD,BCPS, BCCCP
+966114647272
mamer@kfshrc.edu.sa

Mohammed Bawazeer, MD,FRCSC,FACS
+966112162919
mbawazeer@kfshrc.edu.sa

Society of Critical Care Medicine
NCT Number
MeSH Terms
Coronavirus Infections
Syndrome
Critical Illness
Cytokine Release Syndrome
Siltuximab