COPD Acute ExacerbationCORAILNCT05546606
CO2 Removal in Severe Acute exacerbatIons of Chronic Obstructive Lung Diseases
A study testing ECCO2R in people with COPD Acute Exacerbation, run by Assistance Publique - Hôpitaux de Paris at 20 sites in France.
Trial summary
The aim of the study is to determine which standard of care strategy will best benefit very severe Acute Exacerbation (AE) of Chronic Obstructive Pulmonary Disease (COPD), single versus reinforced with ECCO2R and assess the respective efficacy and the safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Acute Exacerbation
- What is being tested?
- ECCO2R
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 20 sitesFrance
- Study dates
- 18 Apr 2023to 8 Apr 2025
- Phase
- Interventional
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
- Known or suspected diagnosis of COPD based on clinical history, pulmonary function test when available, arterial blood gases, physical examination, and chest radiograph
- Worsening dyspnea for < 2 weeks
- Written informed consent signed by patients or their surrogates, with possibility of an emergency procedure with deferred consent
- Patient affiliated to a Social Security System (excluding "AME: aide médicale d'état")
- Negative serum or urinary β-hCG for women of child-bearing potential
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- Very severe AE criteria defined either by:
- Stratum 1: high likelihood of NIV failure defined by PaCO2 > 55 mmHg and pH < 7.25, either at baseline and/or after at least one hour of NIV
- Stratum 2: intubation and IMV since less than 72 hrs, either after NIV failure and/or with pH < 7.30 and PaCO2 > 55 mmHg and PEEPi (end-expiratory occlusion) > 5 cmH2O, while on Assist-Controlled Ventilation with the following parameters: VT: 8 ml/kg, RR: 12/min., applied PEEP: 0 cmH2O
Who cannot join
- Hemodynamic instability
- Known allergy to heparin or to any of the excipients of the specialty used
- Contra-indications to heparin listed in the SmPC of the specialty used.
- History of type II Heparin-induced thrombocytopenia
- Thrombocytopenia (platelets < 100.000/mm3)
- Recent major surgery
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- Haemorrhagic disorders such as:
- Organic lesion likely to bleed
- Bleeding manifestations or tendencies linked to disorders of hemostasis
- Intracerebral hemorrhage
- Uncontrolled arrhythmia
- Bleeding diathesis
- Body Mass Index > 35 kg/m2
- PaO2/FiO2 < 180 mmHg
- Do not intubate order
- Fibrosing idiopathic interstitial pneumonitis (based on the available medical files)
- Neuromuscular diseases (based on the available medical files)
- Patients with tracheotomy
- Patients with severe concomitant chronic systemic disease with a limited probability of survival (< 6 months)
- Severely disabled (confinement to bed and inability to wash or dress alone) patients before AE
- Pregnant woman
- Participation in another interventional study involving human participants up to their ICU discharge, whether the studies include an investigational medical device, or being in the exclusion period at the end of a previous study.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
CHU Angers
Angers, 49933
CHU Besançon
Besançon, 25030
Hôpital Avicennes, AP-HP
Bobigny, 93009
CHD de Vendée
La Roche-sur-Yon, 85925
CH Le Mans
Le Mans, 72000
Hôpital de la Croix-Rousse
Lyon, 69317
Hôpital Nord
Marseille, 13015
CHU Lapeyronie
Montpellier, 34295
CHR Orléans
Orléans, 45067
Hôpital La Pitié Salpêtrière, AP-HP
Paris, 75013
Hôpital Cochin - APHP
Paris, 75014
Hôpital européen Georges Pompidou - APHP
Paris, 75015
Hôpital Tenon
Paris, 75020
CHU la Milétrie
Poitiers, 86021
CHU Pontchaillou
Rennes, 35033
CHU Rouen
Rouen, 76031
Centre Hospitalier de Saint Denis
Saint-Denis, 93200
Nouvel Hôpital Civil Strasbourg
Strasbourg, 67091
CHRU Bretonneau
Tours, 37044
Hôpital d'Instruction des Armées Robert Picqué
Villenave-d'Ornon, 33882
About this study
The aim of the study is to determine which standard of care strategy will best benefit very severe Acute Exacerbation (AE) of Chronic Obstructive Pulmonary Disease (COPD), single versus reinforced with ECCO2R and assess the respective efficacy and the safety. Very severe AE of COPD will be defined by high risk of Non-Invasive Ventilation (NIV) failure defined by need of intubation and/or in-Intensive Care Unit (ICU) mortality (Stratum 1) or by Invasive Mechanical Ventilation (IMV) after NIV failure and/or with severe hyperinflation and hypercapnia (Stratum 2).
Read the detailed description
After inclusions, all patients from Stratum 1 (at high risk of NIV failure) and Stratum 2 (Intubation-IMV) will be randomly assigned to the single standard of care treatment or to the strengthen standard treatment reinforced with ECCO2R . Weaning of IMV in the strengthen standard of care group will precede weaning of ECCO2R. Weaning of NIV in the strengthen standard of care group will precede weaning of ECCO2R, except for patients with long-term NIV. The patients will undergo a maximum of 33 visits over the 1-year study duration, split in 3 successive periods: selection period, treatment period (until the discharge of the ICU or day 28 after randomisation), follow-up period after the discharge of the ICU (or after day 28) up to 1 year (after randomisation).
Selection period: before randomisation, demographics, medical and surgical history, clinical examination (including physical examination, respiration rate, encephalopathy score, sedation score, pain assessment, Simplified Acute Physiology Score 2, central body temperature, systolic and diastolic blood pressures, heart rate), blood sampling, electrocardiogram and ventilator parameters will be recorded.
Follow-up period: ECCO2R will start as soon as possible after randomisation in patients allocated to the strengthen standard of care group. All patients will be evaluated 12 + 2 hours after randomisation, followed by a daily visit with the collection of the following data if applicable: clinical examination, ECCO2R parameters, ventilator parameters, concomitant medications (including sedative drugs), occurrence of adverse events, date, time and criteria if endotracheal intubation (stratum 1). Arterial blood gases, hematology and serum biochemistry parameters will be assayed daily.
End of Research period: all patients will be evaluated at day 60 (+ 7 days), Day 90 (+ 7 days), Day 180 (+ 7 days) and 1 year (+ 7 days) at least by phone contact, with collection of: vital status, functional status (Severely Disabled or not, Katz Index of Independence in Activities of Daily Living), date of ICU discharge (if > Day 28), date of hospital discharge, occurrences of ICU re-admissions, of adverse events, type and length of mechanical ventilation needed if applicable.
- Conditions
- COPD Acute Exacerbation
- Being tested
- ECCO2R
- Keywords
- ECCO2R, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECCO2RDevice
ECCO2R therapy using the Xenios platform, CE-marked medical device of the firm Xenios AG (Heilbronn, Germany), including the following components: Xenios console, iLA active iLA Kit IPS and Novaport Twin (18Fr, 22Fr or 24 Fr) cannulas The maximal duration of ECCO2R therapy with one circuit will be of 29 days in agreement with the regulatory approval of the patient kit.
| Study group | Role | What they receive |
|---|---|---|
| Single standard of care | No intervention | COPD patients who require respiratory support for severe acute exacerbation (AE), either with NIV or with IMV. |
| Strengthen standard of care reinforced with ECCO2R | Other | COPD patients who require respiratory support for severe acute exacerbations (AE), either with NIV or with IMV reinforced with ECCO2R Receives: Device: ECCO2R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
To determine the best strategy between strengthen standard of care reinforced with ECCO2R, versus single standard of care,
Measured: Up to 60 days
Secondary outcomes (14)
Invasive Ventilator-free days (IVFDs)
To assess the efficacy of ECCO2R, based on the time on IMV
Measured: at 28 and 60 days
Ventilator-free days (VFDs), including both IVFDs and non-invasive ventilator-free days (NIV-VFDs)
To assess the efficacy of ECCO2R, based on the time on IMV
Measured: at 28 and 60 days
28 day, 90 day, 180 day and 1 year all-cause mortality rate
To assess the efficacy of ECCO2R, based on the all-cause mortality
Measured: Up to 1 year
Length of ECCO2R therapy
To assess the efficacy of ECCO2R, based on ECCO2R device's performance
Measured: Up to 28 days
Proportion of patients without intubation and IMV (intubation and IMV avoided)
To assess the efficacy of ECCO2R, based on intubation rate
Measured: Up to 28 days
Number of days with active mobilization (outside the bed)
To assess the efficacy of ECCO2R, based on the ability to actively mobilize the patients
Measured: Up to 28 days
Rate of inability to wean from IMV
To assess the safety, based on central venous catheter-related complications
Measured: at Day 28 and Day 60
Rate of ventilator associated pneumonia
To assess the safety, based on central venous catheter-related complications
Measured: at Day 28 and Day 60
Rate of central venous catheter infection
To assess the safety, based on ECCO2R-related complications,
Measured: Up to 28 days
Rate of deep venous thrombosis
To assess the safety, based on ECCO2R-related complications,
Measured: Up to 28 days
Rate of vascular injury caused by cannulation
To assess the safety, based on ECCO2R-related complications,
Measured: Up to 28 days
Rate of severe bleeding (any cause)
To assess the safety, based on ECCO2R-related complications,
Measured: Up to 28 days
Rate of severe hemolysis
To assess the safety, based on ECCO2R-related complications,
Measured: Up to 28 days
Rate of heparin-induced thrombocytopenia - type II
To assess the safety, based on ECCO2R-related complications,
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start18 Apr 2023
- Primary completion10 Jun 2024
- Study completion8 Apr 2025
Why it stopped: Early termination due to industry withdrawal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD Acute ExacerbationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multi-centre, randomized, controlled, open-label
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, Xenios AG
- Responsible party
- Sponsor
- Investigators
- Jean-Luc MD Diehl, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546606
- Sponsor's protocol ID
- P150913J
- Other IDs
- 2022-A01343-40, PHRC-15-557
- Acronym
- CORAIL
- Status last verified
- Jul 2026
- First submitted
- 15 Sep 2022
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared