Critical IllnessNCT04486521
Anti-IL6 and Corticosteroid Monotherapy vs Combination in COVID-19
An observational study of Critical Illness and Corona Virus Infection, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Critical Illness, Corona Virus Infection, Cytokine Release Syndrome
- What is being tested?
- Interleukin 6 (IL6) Antagonist, Interleukin 6 (IL6) Antagonist and corticosteroids and corticosteroid alone
- How many people
- 860 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 22 Jul 2020to 22 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Non COVID-19 related admissions
- Repeated Admission to ICUs/Hospital
- Patient did not receive anti-IL6 or corticosteroids
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Faisal Specialist Hospital and Research Center
Riyadh
Abeer Omar, ORA@kfshrc.edu.sa
Marwa Amer, PharmD, BCPS,BCCCP
About this study
Official title: Clinical Outcome of Anti-IL6 and Corticosteroid Monotherapy vs Combination in COVID-19 Cytokine Release Syndrome
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
- Being tested
- Interleukin 6 (IL6) Antagonist, Interleukin 6 (IL6) Antagonist and corticosteroids, corticosteroid alone
- Medical subject headings
- Critical Illness, Coronavirus Infections, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin 6 (IL6) AntagonistDrug
Also called Tocilizumab, Siltuximab
anti-IL6 alone
Interleukin 6 (IL6) Antagonist and corticosteroidsDrug
anti-IL6 + corticosteroid combination
corticosteroid aloneDrug
dexamethasone, hydrocortisone, methylprednisolone, prednisone. All steroids " other than dexamethasone" will be converted to dexamethasone equivalent
| Study group | Role | What they receive |
|---|---|---|
| Experimental | anti-IL-6 drugs (tocilizumab and siltuximab) Receives: Drug: Interleukin 6 (IL6) Antagonist | |
| Active Comparator 1 | Anti-IL-6 drugs (tocilizumab and siltuximab) and corticosteroids combination Receives: Drug: Interleukin 6 (IL6) Antagonist and corticosteroids | |
| Active Comparator 2 | corticosteroids alone Receives: Drug: corticosteroid alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 28
Secondary outcomes (10)
Median duration of ventilation
From Intubation to extubation date and off Mechanical Ventilation or until ICU discharge, death, or 28 days whichever occurs first.
Measured: Up to Day 28
Median change in the PaO2/FiO2
Ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2)
Measured: 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.
Measured: Up to Day 28
Duration of ICU Stay
To compare ICU LOS
Measured: Up to 28 days
Duration of Hospital Stay
To compare hospital LOS
Measured: Up to 28 days
Mortality Rate
Death that occurs during 28 days
Measured: Up to Day 28
Percentage of participants with adverse events [transaminitis, hyperglycemia]
adverse events that occurs during 28 days
Measured: 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
Measured: Up to 28 days
Rate of superinfection (bacterial, viral, invasive fungal infections)
Measured: Up to 28 days
Time to the first COVID 19 test negative
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start22 Jul 2020
- Primary completion22 Jul 2021 (estimated)
- Study completion22 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 860 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Critical Care Medicine
- Responsible party
- Sponsor
- Investigators
- Marwa Amer, PharmD,BCPS, BCCCP, Principal investigator, King Faisal Specialist Hospital and Research Center- RiyadhMohammed Bawazeer, MD,FRCSC,FACS, Principal investigator, King Faisal Specialist Hospital and Research Center- Riyadh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486521
- Sponsor's protocol ID
- RAC # 2201053
- Status last verified
- Mar 2021
- First submitted
- 22 Jul 2020
- Last updated
- 8 Mar 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 32426754Amer 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Anti-IL6 and Corticosteroid Monotherapy vs Combination in COVID-19 Cytokine Release Syndrome
- ClinicalTrials.gov ID
- NCT04486521
- Acronym / sponsor ID
- RAC # 2201053
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 860 participants (estimated)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Collaborators
- Society of Critical Care Medicine
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 22 Jul 2021 (estimated)
- Study completion
- 22 Jul 2021 (estimated)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Drug: Interleukin 6 (IL6) Antagonistanti-IL-6 drugs (tocilizumab and siltuximab) |
| Active Comparator 1 | – | Drug: Interleukin 6 (IL6) Antagonist and corticosteroidsAnti-IL-6 drugs (tocilizumab and siltuximab) and corticosteroids combination |
| Active Comparator 2 | – | Drug: corticosteroid alonecorticosteroids alone |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Non COVID-19 related admissions
- Repeated Admission to ICUs/Hospital
- Patient did not receive anti-IL6 or corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interleukin 6 (IL6) AntagonistAlso: Tocilizumab, Siltuximabanti-IL6 alone | Drug | Experimental |
| Interleukin 6 (IL6) Antagonist and corticosteroidsanti-IL6 + corticosteroid combination | Drug | Active Comparator 1 |
| corticosteroid alonedexamethasone, hydrocortisone, methylprednisolone, prednisone. All steroids " other than dexamethasone" will be converted to dexamethasone equivalent | Drug | Active Comparator 2 |
Primary outcome
Ventilator-Free Days
Time frame: 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.
10 secondary outcomes
Median duration of ventilation
Time frame: Up to Day 28
Median change in the PaO2/FiO2
Time frame: Up to Day 28
Vasopressor-Free days
Time frame: Up to Day 28
Duration of ICU Stay
Time frame: Up to 28 days
Duration of Hospital Stay
Time frame: Up to 28 days
Mortality Rate
Time frame: Up to Day 28
Percentage of participants with adverse events [transaminitis, hyperglycemia]
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Background: PubMed 32426754Walkey 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.
- Derived from this study: PubMed 34600589Amer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Corona Virus Infection, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa Amer, PharmD,BCPS, BCCCP (+966114647272, mamer@kfshrc.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-Free Days (time frame: Up to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04486521, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.