COVID-19 Acute Respiratory Distress SyndromeNCT05330845
Interleukine 6 (IL6) Assay for Predicting Failure of Spontaneous Breathing in Patients With COVID-19 Acute Respiratory Distress Syndrome
A study testing IL6 assessment and CRP and PCT assessment in people with COVID-19 Acute Respiratory Distress Syndrome, run by Centre Hospitalier Henri Duffaut - Avignon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- IL6 assessment and CRP and PCT assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 5 Aug 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years
- Patients with COVID-19 (positive COVID PCR)
- Use of intubation for mechanical ventilation
Who cannot join
- Use of Extracorporeal Membrane Oxygenation
- Treatment with Tocilizumab (anti-Il6)
- Pregnant woman
- Patients under protective administration or deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- IL6 assessment, CRP and PCT assessment
- Keywords
- Interleukin-6, Acute Respiratory Distress Syndrome, COVID-19
- Medical subject headings
- Respiratory Distress Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL6 assessmentBiological
Blood IL6 will be assessed during trial
CRP and PCT assessmentBiological
Blood CRP and PCT will be assessed during trial
| Study group | Role | What they receive |
|---|---|---|
| Patients with COVID-19 acute respiratory distress syndrome | Other | Patients with acute respiratory distress syndrome due to COVID-19 and requiring mechanical ventilation Receives: Biological: IL6 assessment; Biological: CRP and PCT assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 72 hours after the start of respiratory weaning
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 48 hours after the start of respiratory weaning
Days of mechanical ventilation
Duration of mechanical ventilation (days)
Measured: At the start of respiratory weaning
Number of ventral decubitus
Number of ventral decubitus during mechanical ventilation mode
Measured: At the start of respiratory weaning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start5 Aug 2021
- Primary completion24 Mar 2022
- Study completion31 Dec 2022
Why it stopped: end of recruitment period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Duffaut - Avignon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas POUSSARD, MD, Principal investigator, Centre Hospitalier Henri Duffaut - AvignonEstelle DELAUNAY, MD, Principal investigator, Centre Hospitalier Henri Duffaut - Avignon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330845
- Sponsor's protocol ID
- COVIL6
- Status last verified
- May 2024
- First submitted
- 7 Apr 2022
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interleukine 6 (IL6) Assay for Predicting Failure of Spontaneous Breathing in Patients With COVID-19 Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT05330845
- Acronym / sponsor ID
- COVIL6
- Keywords
- Interleukin-6, Acute Respiratory Distress Syndrome, COVID-19
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: end of recruitment period
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre Hospitalier Henri Duffaut - AvignonUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with COVID-19 acute respiratory distress syndrome | Other | Biological: IL6 assessment, Biological: CRP and PCT assessmentPatients with acute respiratory distress syndrome due to COVID-19 and requiring mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age>18 years
- Patients with COVID-19 (positive COVID PCR)
- Use of intubation for mechanical ventilation
Key exclusion criteria (4 listed)
- Use of Extracorporeal Membrane Oxygenation
- Treatment with Tocilizumab (anti-Il6)
- Pregnant woman
- Patients under protective administration or deprived of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IL6 assessmentBlood IL6 will be assessed during trial | Biological | Patients with COVID-19 acute respiratory distress syndrome |
| CRP and PCT assessmentBlood CRP and PCT will be assessed during trial | Biological | Patients with COVID-19 acute respiratory distress syndrome |
Primary outcome
Serum concentration of IL6
Time frame: Up to 72 hours after the start of respiratory weaning
Change of blood IL6 concentration during switch from a controlled ventilation mode to a weaning ventilation mode in COVID-19 patients
7 secondary outcomes
Serum concentration of CRP and PCT
Time frame: Up to 48 hours after the start of respiratory weaning
Pulmonary wedge pressure
Time frame: Up to 48 hours after the start of respiratory weaning
Respiratory rate
Time frame: Up to 48 hours after the start of respiratory weaning
Fraction of inspired oxygen
Time frame: Up to 48 hours after the start of respiratory weaning
Tidal Volume
Time frame: Up to 48 hours after the start of respiratory weaning
Days of mechanical ventilation
Time frame: At the start of respiratory weaning
Number of ventral decubitus
Time frame: At the start of respiratory weaning
Results and safety
The study was stopped early (reason given: end of recruitment period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas POUSSARD, MD principal investigator
Centre Hospitalier Henri Duffaut - Avignon
Estelle DELAUNAY, MD principal investigator
Centre Hospitalier Henri Duffaut - Avignon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IL6 assessment and CRP and PCT assessment in people with COVID-19 Acute Respiratory Distress Syndrome, run by Centre Hospitalier Henri Duffaut - Avignon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: end of recruitment period). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentration of IL6 (time frame: Up to 72 hours after the start of respiratory weaning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.