NCT04486521

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 860 (estimated)
• Sponsor: King Faisal Specialist Hospital & Research Center · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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

Conditions

• Critical Illness
• Corona Virus Infection
• Cytokine Release Syndrome

Interventions

Type	Name	Description
DRUG	Interleukin 6 (IL6) Antagonist	anti-IL6 alone
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

Timeline

• Start date: 2020-07-22
• Primary completion: 2021-07-22
• Completion: 2021-07-22
• First posted: 2020-07-24
• Last updated: 2021-03-08

Locations

1 site across 1 country: Saudi Arabia

Regulatory

• FDA-regulated drug study