Anti-IL6 and Corticosteroid Monotherapy vs Combination in COVID-19

Sponsor

King Faisal Specialist Hospital & Research Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04486521

Collaborator

Society of Critical Care Medicine (Other)

860

Enrollment

Location

Anticipated Duration (Months)

71.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Critical Illness Corona Virus Infection Cytokine Release Syndrome	Drug: Interleukin 6 (IL6) Antagonist Drug: Interleukin 6 (IL6) Antagonist and corticosteroids Drug: corticosteroid alone

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

860 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 22, 2020

Anticipated Primary Completion Date :

Jul 22, 2021

Anticipated Study Completion Date :

Jul 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental anti-IL-6 drugs (tocilizumab and siltuximab)	Drug: Interleukin 6 (IL6) Antagonist anti-IL6 alone Other Names: Tocilizumab Siltuximab
Active Comparator 1 Anti-IL-6 drugs (tocilizumab and siltuximab) and corticosteroids combination	Drug: Interleukin 6 (IL6) Antagonist and corticosteroids anti-IL6 + corticosteroid combination
Active Comparator 2 corticosteroids alone	Drug: corticosteroid alone dexamethasone, hydrocortisone, methylprednisolone, prednisone. All steroids " other than dexamethasone" will be converted to dexamethasone equivalent

Arm

Intervention/Treatment

Experimental

anti-IL-6 drugs (tocilizumab and siltuximab)

Drug: Interleukin 6 (IL6) Antagonist

anti-IL6 alone

Other Names:

Tocilizumab

Siltuximab

Active Comparator 1

Anti-IL-6 drugs (tocilizumab and siltuximab) and corticosteroids combination

Drug: Interleukin 6 (IL6) Antagonist and corticosteroids

anti-IL6 + corticosteroid combination

Active Comparator 2

corticosteroids alone

Drug: corticosteroid alone

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.
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
Mortality Rate [Up to Day 28]
Death that occurs during 28 days
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult Critically ill patients
COVID-19 PCR positive
Presence of clinical and radiological signs of progressive disease, and laboratory evidence indicative of risk for cytokine storm complications.
Received anti-IL6 or corticosteroids as part of COVID-19 treatment

Exclusion Criteria:

Non COVID-19 related admissions
Repeated Admission to ICUs/Hospital
Patient did not receive anti-IL6 or corticosteroids

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King Faisal Specialist Hospital and Research Center	Riyadh		Saudi Arabia

Sponsors and Collaborators

King Faisal Specialist Hospital & Research Center
Society of Critical Care Medicine

Investigators

Principal Investigator: 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