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

• Conditions: Corona Virus Infection; Cytokine Release Syndrome; Critical Illness
• Interventions: Drug: Interleukin 6 (IL6) Antagonist; Drug: Interleukin 6 (IL6) Antagonist and corticosteroids; Drug: corticosteroid alone

• Registration Number: NCT04486521
• Lead Sponsor: King Faisal Specialist Hospital & Research Center

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

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

Study Timeline

• Study Start: 2020-07-22
• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-24
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-04
• Last Update Posted: 2021-03-08
• Primary Completion: 2021-07-22
• Study Completion: 2021-07-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 860

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental	Interleukin 6 (IL6) Antagonist	anti-IL-6 drugs (tocilizumab and siltuximab)
Active Comparator 1	Interleukin 6 (IL6) Antagonist and corticosteroids	Anti-IL-6 drugs (tocilizumab and siltuximab) and corticosteroids combination
Active Comparator 2	corticosteroid alone	corticosteroids alone

Primary Outcome Measures

Name	Time	Method
Ventilator-Free Days	Up to Day 28	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.

Secondary Outcome Measures

Name	Time	Method
Rate of superinfection (bacterial, viral, invasive fungal infections)	Up to 28 days
Time to the first COVID 19 test negative	Up to 28 days
Mortality Rate	Up to Day 28	Death that occurs during 28 days
Duration of ICU Stay	Up to 28 days	To compare ICU LOS
Duration of Hospital Stay	Up to 28 days	To compare hospital LOS
Median duration of ventilation	Up to Day 28	From Intubation to extubation date and off Mechanical Ventilation or until ICU discharge, death, or 28 days whichever occurs first.
Median change in the PaO2/FiO2	Up to Day 28	Ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2)
Vasopressor-Free days	Up to Day 28	The median vasopressor-free days will be calculated as calendar days with no vasopressor support to day 28. Participants who die before day 28 are assigned zero free days.
Percentage of participants with adverse events [transaminitis, hyperglycemia]	Up to 28 days	adverse events that occurs during 28 days
Concentration of Ferritin, IL6, D dimer, fibrinogen, C-reactive protein (CRP), Lactate dehydrogenase (LDH) and absolute lymphocyte count and their correlation with the effectiveness of the treatment	Up to 28 days	Concentration of inflammatory markers

Trial Locations

Locations (1)

King Faisal Specialist Hospital and Research Center; 🇸🇦 Riyadh, Saudi Arabia