Interleukine 6 (IL6) Assay for Predicting Failure of Spontaneous Breathing in Patients With COVID-19 Acute Respiratory Distress Syndrome

Centre Hospitalier Henri Duffaut - Avignon

Status: Terminated

Conditions: COVID-19 Acute Respiratory Distress Syndrome

Treatments: Biological: IL6 assessment; Biological: CRP and PCT assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT05330845

COVIL6

Details and patient eligibility

About

In the current COVID-19 pandemic, many patients have an acute respiratory distress syndrome (ARDS). Among mechanisms related to COVID-19 acute respiratory distress syndrome, cytokine storm and secretion of IL-6 play a central role. ARDS management involves intubation for protective mechanical ventilation, deep sedation and curarisation.

During intensive care unit (ICU) hospitalization, improvement of hematosis induces a switch from a controlled ventilation mode to a withdrawal ventilation mode, such as Spontaneous Ventilation with Pressure Support (SP-PS) or Adaptative Support Ventilation (ASV). This step is essential prior to considering complete weaning from controlled ventilation and sometimes ends with a failure. In this case, deterioration of hematosis and/or ventilatory mechanics is observed.

At the same time as withdrawal failure, the investigators observed biological inflammatory rebound in some patients. Therefore, influence of inflammatory biological parameters, including IL-6, on withdrawal failure, needs to be investigated. To this end, the investigators decide to dose different inflammatory markers - such as IL6, C-Reactive Protein (CRP), Procalcitonin (PCT) - in patients with acute respiratory distress syndrome due to COVID-19, during standard of care. Indeed, in patients with acute respiratory distress syndrome not due to COVID-19, the increase in IL6 is a negative prognosis during medical first aid but also when the mechanical ventilation is withdrawn. In addition, IL6 rise is associated with poor prognosis for patients with COVID-19 and longer stays in intensive care.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age>18 years
• Patients with COVID-19 (positive COVID PCR)
• Use of intubation for mechanical ventilation

Exclusion criteria

• Use of Extracorporeal Membrane Oxygenation
• Treatment with Tocilizumab (anti-Il6)
• Pregnant woman
• Patients under protective administration or deprived of liberty

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Patients with COVID-19 acute respiratory distress syndrome

Other group

Description:

Patients with acute respiratory distress syndrome due to COVID-19 and requiring mechanical ventilation

Treatment:

Biological: CRP and PCT assessment

Biological: IL6 assessment