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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04486521
• Other study ID #: RAC # 2201053
• Status: Recruiting
• Start date: July 22, 2020
• Est. completion date: July 22, 2021

Study information

• Verified date: March 2021
• Source: King Faisal Specialist Hospital & Research Center
• Contact: Marwa Amer, PharmD,BCPS, BCCCP
• Phone: +966114647272
• Email: mamer[@]kfshrc.edu.sa
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 860
• Est. completion date: July 22, 2021
• Est. primary completion date: July 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• Critical Illness
• Cytokine Release Syndrome
• Severe Acute Respiratory Syndrome
• Syndrome

Intervention

Drug:
• Interleukin 6 (IL6) Antagonist
anti-IL6 alone
• Interleukin 6 (IL6) Antagonist and corticosteroids
anti-IL6 + corticosteroid combination
• corticosteroid alone
dexamethasone, hydrocortisone, methylprednisolone, prednisone. All steroids " other than dexamethasone" will be converted to dexamethasone equivalent

Locations

Country	Name	City	State
Saudi Arabia	King Faisal Specialist Hospital and Research Center	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
King Faisal Specialist Hospital & Research Center	Society of Critical Care Medicine

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (1)

Walkey AJ, Kumar VK, Harhay MO, Bolesta S, Bansal V, Gajic O, Kashyap R. The Viral Infection and Respiratory Illness Universal Study (VIRUS): An International Registry of Coronavirus 2019-Related Critical Illness. Crit Care Explor. 2020 Apr 29;2(4):e0113. doi: 10.1097/CCE.0000000000000113. eCollection 2020 Apr. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator-Free Days	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.	Up to Day 28
Secondary	Median duration of ventilation	From Intubation to extubation date and off Mechanical Ventilation or until ICU discharge, death, or 28 days whichever occurs first.	Up to Day 28
Secondary	Median change in the PaO2/FiO2	Ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2)	Up to Day 28
Secondary	Vasopressor-Free days	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.	Up to Day 28
Secondary	Duration of ICU Stay	To compare ICU LOS	Up to 28 days
Secondary	Duration of Hospital Stay	To compare hospital LOS	Up to 28 days
Secondary	Mortality Rate	Death that occurs during 28 days	Up to Day 28
Secondary	Percentage of participants with adverse events [transaminitis, hyperglycemia]	adverse events that occurs during 28 days	Up to 28 days
Secondary	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	Concentration of inflammatory markers	Up to 28 days
Secondary	Rate of superinfection (bacterial, viral, invasive fungal infections)		Up to 28 days
Secondary	Time to the first COVID 19 test negative		Up to 28 days