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

NCT04486521 | Unknown FDA Drug

• 1 other identifier: RAC # 2201053
• Study Type: observational
• Target: 860
• Locations: 1 country
• Sites: 1

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

Conditions

Critical Illness; Corona Virus Infection; Cytokine Release Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Median duration of ventilation

  Up to Day 28

• Median change in the PaO2/FiO2

  Up to Day 28

• Vasopressor-Free days

  Up to Day 28

• Duration of ICU Stay

  Up to 28 days

• Duration of Hospital Stay

  Up to 28 days

Study Arms (3)

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

Interleukin 6 (IL6) Antagonist DRUG

anti-IL6 alone

Also known as: Tocilizumab, Siltuximab

Experimental

Interleukin 6 (IL6) Antagonist and corticosteroids DRUG

anti-IL6 + corticosteroid combination

Active Comparator 1

corticosteroid alone DRUG

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

Active Comparator 2

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead
• Society of Critical Care Medicine: collaborator

Study Sites (1)

King Faisal Specialist Hospital and Research Center

Riyadh, Saudi Arabia

RECRUITING

Related Publications (2)

• 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.

  PMID: 32426754 BACKGROUND

• 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.

  PMID: 34600589 DERIVED

MeSH Terms

Conditions

Critical Illness; Coronavirus Infections; Cytokine Release Syndrome

Interventions

Interleukin-6; tocilizumab; siltuximab; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• 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

Central Study Contacts

Marwa Amer, PharmD,BCPS, BCCCP

CONTACT

+966114647272; mamer@kfshrc.edu.sa

Mohammed Bawazeer, MD,FRCSC,FACS

CONTACT

+966112162919; mbawazeer@kfshrc.edu.sa

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 24, 2020
• Study Start: July 22, 2020
• Primary Completion: July 22, 2021
• Study Completion: July 22, 2021
• Last Updated: March 8, 2021

Record last verified: 2021-03

Locations

SA (1)