ARDS Related to Severe Acute Respiratory Syndrome-Coronavirus (SARS-CoV) 2ECMO-SARSNCT04397588
Extracorporeal Membrane Oxygenation (ECMO) and Coronavirus Disease (COVID) 19
An observational study of ARDS Related to Severe Acute Respiratory Syndrome-Coronavirus (SARS-CoV) 2 and Acute Refractory Heart Failure Related to SARS-CoV 2, run by Rennes University Hospital at 44 sites in France.
Trial summary
The role of ECMO in the treatment of patients with severe COVID-19 (Acute Respiratory Distress Syndrome (ARDS) and/or acute refractory heart failure) is not yet known. The present study will aim to report the results of the ECMO management of the most severe forms of COVID-19 through the first French ECMO registry. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ARDS Related to Severe Acute Respiratory Syndrome-Coronavirus (SARS-CoV) 2, Acute Refractory Heart Failure Related to SARS-CoV 2
- How many people
- 761 participants
- Where
- 44 sitesFrance
- Study dates
- 21 Apr 2020to 24 May 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Critically ill COVID-19 patients with ARDS or/and acute refractory heart failure
Who may be able to join
- All COVID-19 patients, adults or children,
- Tested positive by RT-PCR for SARS-CoV2 (nasopharyngeal swabs, sputum, endotracheal aspiration, bronchoalveolar lavage or stool sample) and / or with a diagnosis made on chest CT findings,
- Supported by venovenous or venoarterial ECMO
Who cannot join
- Temporary legally protected Adults over a set period or waiting for protection supervision, guardianship
- Patients or proxies who express their opposition to study participation
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
France44 sites
Angers University Hospital
Angers, 49933
Besançon Hospital
Besançon, 25030
Brest university Hospital
Brest, 29200
Caen University Hospital
Caen, 14033
Clermont ferrand University hospital
Clermont-Ferrand, 63003
APHP Henri Mondor Paris University Hospital
Créteil, 94000
Dijon University Hospital
Dijon, 21079
Vendée Hospital
La Roche-sur-Yon, 85000
Grenoble University Hospital
La Tronche, 38700
APHP Kremli Bicetre Paris University Hospital
Le Kremlin-Bicêtre, 94275
Marie Lannelongue Hospital
Le Plessis-Robinson, 92350
Lens Hospital
Lens, 62307
Lille University Hospital
Lille, 59000
Limoges University Hospital
Limoges, 87042
Clinique de la Sauvegarde
Lyon, 69337
Lyon University Hospital
Lyon, 69500
Marseille Européen Hospital
Marseille, 13003
APHM la Timone- Marseille University Hospital
Marseille, 13005
Clairval Hospital
Marseille, 13009
Metz University Hospital
Metz, 45000
Montpellier University Hospital
Montpellier, 34090
Emile Muller Hospital
Mulhouse, 68051
Nancy University Hospital
Nancy, 54511
Nantes University Hospital
Nantes, 44000
Ambroise Paré Hospital
Neuilly-sur-Seine, 92200
Nimes University Hospital
Nîmes, 30029
Institut Mutualiste Montsouris
Paris, 75014
APHP Hopital Européen Georges Pompidou - Paris University Hospital
Paris, 75015
APHP necker Paris University Hospital
Paris, 75015
APHP Bichat - Paris University Hospital
Paris, 75018
APHP La Pitié Salpêtrière Paris University Hospital
Paris, 75651
Bordeaux University Hospital
Pessac, 33604
Poitiers University hospital
Poitiers, 86000
Reims University hospital
Reims, 51092
Rennes University hospital
Rennes, 35000
Rouen University Hospital
Rouen, 76031
Saint brieuc Hospital
Saint-Brieuc, 22027
La Réunion University Hospital
Saint-Denis, 97400
Saint Etienne University Hospital
Saint-Etienne, 42000
Saint Nazaire Hospital
Saint-Nazaire, 44606
Strasbourg University Hospital
Strasbourg, 67091
Toulouse University Hospital - Rangueil Hospital
Toulouse, 31000
Tours University Hospital
Tours, 37044
Bretagne Atlantique Hospital
Vannes, 56000
About this study
Official title: Extracorporeal Membrane Oxygenation (ECMO) as a Therapeutic Option in Severe Form of COVID-19: a Nationwide Cohort Study
The role of ECMO in the treatment of patients with severe COVID-19 (Acute Respiratory Distress Syndrome (ARDS) and/or acute refractory heart failure) is not yet known. The present study will aim to report the results of the ECMO management of the most severe forms of COVID-19 through the first French ECMO registry.
Read the detailed description
The main objective of this study is to evaluate the hospital survival of COVID-19 patients supported by venovenous or venoarterial ECMO in a multicenter registry.
The secondary objectives are to describe the characteristics of COVID-19 patients who have received ECMO support, to identify the risk factors associated with hospital mortality, to analyze the outcomes after ECMO weaning including survival at day 28 and day 90, and to analyze the utility of a circulatory support mobile unit in a severe pandemic
Inclusions are both prospective and retrospective in order to collect data over the whole pandemic
- Conditions
- ARDS Related to Severe Acute Respiratory Syndrome-Coronavirus (SARS-CoV) 2, Acute Refractory Heart Failure Related to SARS-CoV 2
- Keywords
- ECMO, COVID-19, SARS-CoV2, ARDS, Myocarditis, Heart failure
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19, Myocarditis, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality
Hospital mortality
Measured: up to 90 days
Secondary outcomes (5)
Mortality Day 28
Mortality Day 28
Measured: Day 28
Mortality Day 90
Mortality Day 90
Measured: Day 90
Ventilator-free days
Ventilator-free days
Measured: Day 28
Intensive care unit-free days
ICU-free days
Measured: Day 28
Hospital-free days
Hospital-free days
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start21 Apr 2020
- Primary completion24 May 2022
- Study completion24 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ARDS Related to Severe Acute Respiratory Syndrome-Coronavirus (SARS-CoV) 2Studies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 761 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Nesseler, doctor, Principal investigator, Rennes University HospitalAndré Vincentelli, professor, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397588
- Sponsor's protocol ID
- 35RC20_8979 ECMO-SARS
- Acronym
- ECMO-SARS
- Status last verified
- Jun 2026
- First submitted
- 19 May 2020
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Nesseler N, Mansour A, Schmidt M, Para M, Porto A, Falcoz PE, Mongardon N, Fougerou C, Ross JT, Beurton A, Gaide-Chevronnay L, Guinot PG, Lebreton G, Flecher E, Vincentelli A, Massart N; ECMOSARS Investigators; SFAR Research Network. Healthcare-associated infections in patients with severe COVID-19 supported with extracorporeal membrane oxygenation: a nationwide cohort study. Crit Care. 2024 Feb 20;28(1):54. doi: 10.1186/s13054-024-04832-3.
PubMed 38374103Massart N, Guervilly C, Mansour A, Porto A, Flecher E, Esvan M, Fougerou C, Fillatre P, Duburcq T, Lebreton G, Para M, Stephan F, Hraiech S, Ross JT, Schmidt M, Vincentelli A, Nesseler N; Extracorporeal Membrane Oxygenation for Respiratory Failure and/or Heart failure related to Severe Acute Respiratory Syndrome Coronavirus 2 (ECMOSARS) Investigators. Impact of Prone Position in COVID-19 Patients on Extracorporeal Membrane Oxygenation. Crit Care Med. 2023 Jan 1;51(1):36-46. doi: 10.1097/CCM.0000000000005714. Epub 2022 Nov 11.
PubMed 36519982Mansour A, Flecher E, Schmidt M, Rozec B, Gouin-Thibault I, Esvan M, Fougerou C, Levy B, Porto A, Ross JT, Para M, Manganiello S, Lebreton G, Vincentelli A, Nesseler N; ECMOSARS Investigators. Bleeding and thrombotic events in patients with severe COVID-19 supported with extracorporeal membrane oxygenation: a nationwide cohort study. Intensive Care Med. 2022 Aug;48(8):1039-1052. doi: 10.1007/s00134-022-06794-y. Epub 2022 Jul 13.
PubMed 35829723
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Membrane Oxygenation (ECMO) as a Therapeutic Option in Severe Form of COVID-19: a Nationwide Cohort Study
- ClinicalTrials.gov ID
- NCT04397588
- Acronym / sponsor ID
- ECMO-SARS / 35RC20_8979 ECMO-SARS
- Conditions
- ARDS Related to Severe Acute Respiratory Syndrome-Coronavirus (SARS-CoV) 2, Acute Refractory Heart Failure Related to SARS-CoV 2
- Keywords
- ECMO, COVID-19, SARS-CoV2, ARDS, Myocarditis, Heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 761 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 21 May 2020 (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.
The role of ECMO in the treatment of patients with severe COVID-19 (Acute Respiratory Distress Syndrome (ARDS) and/or acute refractory heart failure) is not yet known. The present study will aim to report the results of the ECMO management of the most severe forms of COVID-19 through the first French ECMO registry.
Detailed description
The main objective of this study is to evaluate the hospital survival of COVID-19 patients supported by venovenous or venoarterial ECMO in a multicenter registry.
The secondary objectives are to describe the characteristics of COVID-19 patients who have received ECMO support, to identify the risk factors associated with hospital mortality, to analyze the outcomes after ECMO weaning including survival at day 28 and day 90, and to analyze the utility of a circulatory support mobile unit in a severe pandemic
Inclusions are both prospective and retrospective in order to collect data over the whole pandemic
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critically ill COVID-19 patients with ARDS or/and acute refractory heart failure
Key inclusion criteria (3 listed)
- All COVID-19 patients, adults or children,
- Tested positive by RT-PCR for SARS-CoV2 (nasopharyngeal swabs, sputum, endotracheal aspiration, bronchoalveolar lavage or stool sample) and / or with a diagnosis made on chest CT findings,
- Supported by venovenous or venoarterial ECMO
Key exclusion criteria (2 listed)
- Temporary legally protected Adults over a set period or waiting for protection supervision, guardianship
- Patients or proxies who express their opposition to study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospital mortality
Time frame: up to 90 days
Hospital mortality
5 secondary outcomes
Mortality Day 28
Time frame: Day 28
Mortality Day 90
Time frame: Day 90
Ventilator-free days
Time frame: Day 28
Intensive care unit-free days
Time frame: Day 28
Hospital-free days
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Derived from this study: PubMed 38374103Nesseler N, Mansour A, Schmidt M, Para M, Porto A, Falcoz PE, Mongardon N, Fougerou C, Ross JT, Beurton A, Gaide-Chevronnay L, Guinot PG, Lebreton G, Flecher E, Vincentelli A, Massart N; ECMOSARS Investigators; SFAR Research Network. Healthcare-associated infections in patients with severe COVID-19 supported with extracorporeal membrane oxygenation: a nationwide cohort study. Crit Care. 2024 Feb 20;28(1):54. doi: 10.1186/s13054-024-04832-3.
- Derived from this study: PubMed 36519982Massart N, Guervilly C, Mansour A, Porto A, Flecher E, Esvan M, Fougerou C, Fillatre P, Duburcq T, Lebreton G, Para M, Stephan F, Hraiech S, Ross JT, Schmidt M, Vincentelli A, Nesseler N; Extracorporeal Membrane Oxygenation for Respiratory Failure and/or Heart failure related to Severe Acute Respiratory Syndrome Coronavirus 2 (ECMOSARS) Investigators. Impact of Prone Position in COVID-19 Patients on Extracorporeal Membrane Oxygenation. Crit Care Med. 2023 Jan 1;51(1):36-46. doi: 10.1097/CCM.0000000000005714. Epub 2022 Nov 11.
- Derived from this study: PubMed 35829723Mansour A, Flecher E, Schmidt M, Rozec B, Gouin-Thibault I, Esvan M, Fougerou C, Levy B, Porto A, Ross JT, Para M, Manganiello S, Lebreton G, Vincentelli A, Nesseler N; ECMOSARS Investigators. Bleeding and thrombotic events in patients with severe COVID-19 supported with extracorporeal membrane oxygenation: a nationwide cohort study. Intensive Care Med. 2022 Aug;48(8):1039-1052. doi: 10.1007/s00134-022-06794-y. Epub 2022 Jul 13.
- Individual participant dataSharing planned: Undecided
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 Nesseler, doctor principal investigator
Rennes University Hospital
André Vincentelli, professor principal investigator
University Hospital, Lille
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS Related to Severe Acute Respiratory Syndrome-Coronavirus (SARS-CoV) 2 and Acute Refractory Heart Failure Related to SARS-CoV 2, run by Rennes University Hospital at 44 sites 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 2 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: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hospital mortality (time frame: up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04397588, which also lists 3 linked publications.
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 12 Jun 2026.