Clinical trial NCT04486521: Anti-IL6 and Corticosteroid Monotherapy vs Combination in COVID-19
Official title: Clinical Outcome of Anti-IL6 and Corticosteroid Monotherapy vs Combination in COVID-19 Cytokine Release Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Corona Virus Infection
Cytokine Release Syndrome
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
Collaborators: name: Society of Critical Care Medicine
First posted: 2020-07-24
Enrollment: 860
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Data elements will be retrieved from Viral Infection and Respiratory Illness Universal Study: COVID-19 (VIRUS registry ClinicalTrials.gov Identifier: NCT04323787) which is a prospective, non-interventional, multi-center, multi-national observational cross sectional study.

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

Eligibility criteria: 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

Primary outcomes:
measure: Ventilator-Free Days
timeFrame: Up to Day 28
Secondary outcomes:
measure: Median duration of ventilation
timeFrame: Up to Day 28
measure: Median change in the PaO2/FiO2
timeFrame: Up to Day 28
measure: Vasopressor-Free days
timeFrame: Up to Day 28
measure: Duration of ICU Stay
timeFrame: Up to 28 days
measure: Duration of Hospital Stay
timeFrame: Up to 28 days
measure: Mortality Rate
timeFrame: Up to Day 28
measure: Percentage of participants with adverse events [transaminitis, hyperglycemia]
timeFrame: Up to 28 days
measure: 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
timeFrame: Up to 28 days
measure: Rate of superinfection (bacterial, viral, invasive fungal infections)
timeFrame: Up to 28 days
measure: Time to the first COVID 19 test negative
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital and Research Center
Study officials:
affiliation: King Faisal Specialist Hospital and Research Center- Riyadh
name: Marwa Amer, PharmD,BCPS, BCCCP
role: PRINCIPAL_INVESTIGATOR
affiliation: King Faisal Specialist Hospital and Research Center- Riyadh
name: Mohammed Bawazeer, MD,FRCSC,FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Amer M, Kamel AM, Bawazeer M, Maghrabi K, Butt A, Dahhan T, Kseibi E, Khurshid SM, Abujazar M, Alghunaim R, Rabee M, Abualkhair M, Al-Janoubi A, AlFirm AT, Gajic O, Walkey AJ, Mosier JM, Zabolotskikh IB, Gavidia OY, Teruel SY, Bernstein MA, Boman K, Kumar VK, Bansal V, Kashyap R; Society of Critical Care Medicine Discovery Viral Infection and Respiratory Illness Universal Study (VIRUS): COVID-19 Registry Investigator Group. Clinical characteristics and outcomes of critically ill mechanically ventilated COVID-19 patients receiving interleukin-6 receptor antagonists and corticosteroid therapy: a preliminary report from a multinational registry. Eur J Med Res. 2021 Oct 2;26(1):117. doi: 10.1186/s40001-021-00591-x.