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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

860 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-22

Study Completion Date

2021-07-22

Brief Summary

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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

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Detailed Description

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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

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Critical Illness Corona Virus Infection Cytokine Release Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental

anti-IL-6 drugs (tocilizumab and siltuximab)

Interleukin 6 (IL6) Antagonist

Intervention Type DRUG

anti-IL6 alone

Active Comparator 1

Anti-IL-6 drugs (tocilizumab and siltuximab) and corticosteroids combination

Interleukin 6 (IL6) Antagonist and corticosteroids

Intervention Type DRUG

anti-IL6 + corticosteroid combination

Active Comparator 2

corticosteroids alone

corticosteroid alone

Intervention Type DRUG

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

Interventions

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Interleukin 6 (IL6) Antagonist

anti-IL6 alone

Intervention Type DRUG

Interleukin 6 (IL6) Antagonist and corticosteroids

anti-IL6 + corticosteroid combination

Intervention Type DRUG

corticosteroid alone

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

Intervention Type DRUG

Other Intervention Names

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Tocilizumab Siltuximab

Eligibility Criteria

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Inclusion Criteria

1. Adult Critically ill patients
2. COVID-19 PCR positive
3. Presence of clinical and radiological signs of progressive disease, and laboratory evidence indicative of risk for cytokine storm complications.
4. Received anti-IL6 or corticosteroids as part of COVID-19 treatment