Status unknownNCT04486521Updated Mar 8, 2021

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

An observational study in Critical Illness, Corona Virus Infection and Cytokine Release Syndrome, sponsored by King Faisal Specialist Hospital & Research Center. Status unknown at 1 site in Saudi Arabia. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2021-03-08.

Sponsored by King Faisal Specialist Hospital & Research Center · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.

Study type: Observational
Model: Other
Time perspective: Prospective
Enrollment: 860
Ages: 14 Years and older
Sex: All

Study 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

Read the 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

Conditions studied

Critical Illness
Corona Virus Infection
Cytokine Release Syndrome

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In context

Coronavirus Infections

929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.

This study's planned enrollment of 860 is above the median of 300 across 334 observational studies indexed under Coronavirus Infections.

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Lead sponsor

King Faisal Specialist Hospital & Research Center is the lead sponsor of 98 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 14 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

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.

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

Exclusion Criteria:

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

Study design

Observational model: Other
Time perspective: Prospective
Enrollment: 860 participants (estimated)
Patient registry: No

Groups and cohorts

Experimental
anti-IL-6 drugs (tocilizumab and siltuximab)
Drug: Interleukin 6 (IL6) Antagonist
Active Comparator 1
Anti-IL-6 drugs (tocilizumab and siltuximab) and corticosteroids combination
Drug: Interleukin 6 (IL6) Antagonist and corticosteroids
Active Comparator 2
corticosteroids alone
Drug: corticosteroid alone

Interventions

DrugInterleukin 6 (IL6) Antagonist
anti-IL6 alone
Also known as: Tocilizumab, Siltuximab
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

What researchers measure

Primary outcomes

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.
Time frame: Up to Day 28

Secondary outcomes

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

Study locations

1 of 1 sites recruiting

King Faisal Specialist Hospital and Research Center
Riyadh, Saudi Arabia
- Abeer Omar · Contact · ORA@kfshrc.edu.sa
- Marwa Amer, PharmD, BCPS,BCCCP · Principal investigator
- Mohammed Bawazeer, MD, FRCSC, FACS · Principal investigator
- Eiad Kseibi, MD · Sub investigator
- Talal Dahhan, MD · Sub investigator
- Abid Butt, MD · Sub investigator
- Syed Moazzum Khurshid, MD · Sub investigator
- Muath Rabee, MD · Sub investigator
- Mohammed Abujazar, MD · Sub investigator
- Razan Alghunaim, PharmD · Sub investigator
- Maal Abualkhair, MD · Sub investigator
- Abeer AlFirm, Associate RC Data Manager · Sub investigator
Recruiting

References and documents

Publications

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. PubMed 32426754 ↗
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. PubMed 34600589 ↗

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04486521
Lead sponsor: King Faisal Specialist Hospital & Research Center
Collaborators: Society of Critical Care Medicine
Responsible party: Sponsor
First posted: Jul 24, 2020
Start date: Jul 22, 2020
Primary completion: Jul 22, 2021 (estimated)
Completion: Jul 22, 2021 (estimated)
Last update: Mar 8, 2021

Study contacts

Marwa Amer, PharmD,BCPS, BCCCP

Contact

mamer@kfshrc.edu.sa

+966114647272

Mohammed Bawazeer, MD,FRCSC,FACS

Contact

mbawazeer@kfshrc.edu.sa

+966112162919

Marwa Amer, PharmD,BCPS, BCCCP

principal investigator · King Faisal Specialist Hospital and Research Center- Riyadh

Mohammed Bawazeer, MD,FRCSC,FACS

principal investigator · King Faisal Specialist Hospital and Research Center- Riyadh

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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