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

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the increase in IL6 is a negative prognosis during medical first aid but also when the mechanical ventilation is withdrawn.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.

Study Overview

• Status: Terminated
• Conditions: COVID-19 Acute Respiratory Distress Syndrome
• Intervention / Treatment: Biological: IL6 assessment; Biological: CRP and PCT assessment

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Vaucluse
    • Avignon, Vaucluse, France, 84000
      • Centre Hospitalier Henri Duffaut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with COVID-19 acute respiratory distress syndrome; Patients with acute respiratory distress syndrome due to COVID-19 and requiring mechanical ventilation	Biological: IL6 assessment; Blood IL6 will be assessed during trial; Biological: CRP and PCT assessment; Blood CRP and PCT will be assessed during trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum concentration of IL6	Change of blood IL6 concentration during switch from a controlled ventilation mode to a weaning ventilation mode in COVID-19 patients	Up to 72 hours after the start of respiratory weaning

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum concentration of CRP and PCT	Change of blood CRP et PCT concentration during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients	Up to 48 hours after the start of respiratory weaning
Pulmonary wedge pressure	Change of pulmonary wedge pressure (in mmHg), respiratory rate (in breaths per minute), Fraction of inspired oxygen (FiO2, in percentage), Tidal Volume (in ml/kg) during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients	Up to 48 hours after the start of respiratory weaning
Respiratory rate	Change of respiratory rate (in breaths per minute) during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients	Up to 48 hours after the start of respiratory weaning
Fraction of inspired oxygen	Change of Fraction of inspired oxygen (FiO2, in percentage) during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients	Up to 48 hours after the start of respiratory weaning
Tidal Volume	Change of Tidal Volume (in ml/kg) during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients	Up to 48 hours after the start of respiratory weaning
Days of mechanical ventilation	Duration of mechanical ventilation (days)	At the start of respiratory weaning
Number of ventral decubitus	Number of ventral decubitus during mechanical ventilation mode	At the start of respiratory weaning

Collaborators and Investigators

• Sponsor: Centre Hospitalier Henri Duffaut - Avignon
• Investigators: Principal Investigator: Nicolas POUSSARD, MD, Centre Hospitalier Henri Duffaut - Avignon; Principal Investigator: Estelle DELAUNAY, MD, Centre Hospitalier Henri Duffaut - Avignon

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Actual): March 24, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 7, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; Acute Respiratory Distress Syndrome; Interleukin-6
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: COVIL6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No