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

King Faisal Specialist Hospital & Research Center

Status: Unknown

Conditions: Cytokine Release Syndrome; Corona Virus Infection; Critical Illness

Treatments: Drug: Interleukin 6 (IL6) Antagonist and corticosteroids; Drug: Interleukin 6 (IL6) Antagonist; Drug: corticosteroid alone

Study type: Observational

Funder types: Other

Identifiers

NCT04486521

RAC # 2201053

Details and patient eligibility

About

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

Full 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

Enrollment: 860 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

860 participants in 3 patient groups

Experimental

Description:

anti-IL-6 drugs (tocilizumab and siltuximab)

Treatment:

Drug: Interleukin 6 (IL6) Antagonist

Active Comparator 1

Description:

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

Treatment:

Drug: Interleukin 6 (IL6) Antagonist and corticosteroids

Active Comparator 2

Description:

corticosteroids alone

Treatment:

Drug: corticosteroid alone