Clinical Outcome of Anti-IL6 vs Anti-IL6 Corticosteroid Combination in Patients With SARS-CoV-2 Cytokine Release Syndrome

  • STATUS
    Recruiting
  • participants needed
    11000
  • sponsor
    King Faisal Specialist Hospital & Research Center
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Updated on 19 February 2024
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critical illness
cytokines
shock
interleukin-6
pneumonia
covid-19
SARS
cytokine release syndrome
cytokine storm
acute respiratory syndrome (sars)

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

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

Details
Condition Critical Illness, Corona Virus Infection, Cytokine Release Syndrome
Age 14years - 100years
Treatment Interleukin 6 (IL6) Antagonist, Interleukin 6 (IL6) Antagonist and corticosteroids
Clinical Study IdentifierNCT04486521
SponsorKing Faisal Specialist Hospital & Research Center
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
Clear my responses
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