Respiratory Distress SyndromeECMO-COVID-19NCT04343404
Place of ECMO in the Management of Severe Refractory ARDS Associated With Covid-19
An observational study of Respiratory Distress Syndrome, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Describe COVID-19 patients who are receiving ECMO-VV respiratory replacement and what happens to them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 15 Apr 2020
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients with a COVID-19 diagnosis by RT-PCR
Who may be able to join
- Patient over the age of 18;
- Diagnostic COVID-19 by RT-PCR;
- Hospitalisation in resuscitation for the management of complications related to COVID-19
- Implanted ECMO-VV during hospitalisation;
- Patient agreeing to participate in the study
Who cannot join
- Sujet under guardianship or trusteeship
- Sujet under safeguard of justice
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Thoracique Nouvel Hôpital Civil Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: STUDY ECMO-COVID-19 : Place of ECMO in the Management of Severe Refractory ARDS Associated With Covid-19
Describe COVID-19 patients who are receiving ECMO-VV respiratory replacement and what happens to them.
- Conditions
- Respiratory Distress Syndrome
- Keywords
- Respiratory Distress Syndrome, ARDS, SARS-COV-2, Extracorporeal membrane oxygenation, ECMO, Veno-venous ECMO
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective description of COVID-19 patients receiving respiratory ECMO-VV supplementation and what happens to them
Measured: Files analysed retrospectily from March 1st, 2020 to April 15, 2020 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start1 Apr 2020
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Emmanuel FALCOZ, MD, PhD, Study director, Service de Chirurgie Thoracique Nouvel Hôpital Civl Hôpitaux Univesitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343404
- Sponsor's protocol ID
- 7772
- Acronym
- ECMO-COVID-19
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2020
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STUDY ECMO-COVID-19 : Place of ECMO in the Management of Severe Refractory ARDS Associated With Covid-19
- ClinicalTrials.gov ID
- NCT04343404
- Acronym / sponsor ID
- ECMO-COVID-19 / 7772
- Conditions
- Respiratory Distress Syndrome
- Keywords
- Respiratory Distress Syndrome, ARDS, SARS-COV-2, Extracorporeal membrane oxygenation, ECMO, Veno-venous ECMO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 13 Apr 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.
Describe COVID-19 patients who are receiving ECMO-VV respiratory replacement and what happens to them.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a COVID-19 diagnosis by RT-PCR
Key inclusion criteria (5 listed)
- Patient over the age of 18;
- Diagnostic COVID-19 by RT-PCR;
- Hospitalisation in resuscitation for the management of complications related to COVID-19
- Implanted ECMO-VV during hospitalisation;
- Patient agreeing to participate in the study
Key exclusion criteria (2 listed)
- Sujet under guardianship or trusteeship
- Sujet under safeguard of justice
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
Retrospective description of COVID-19 patients receiving respiratory ECMO-VV supplementation and what happens to them
Time frame: Files analysed retrospectily from March 1st, 2020 to April 15, 2020 will be examined
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 29 Jun 2020.
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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.
Pierre-Emmanuel FALCOZ, MD, PhD study director
Service de Chirurgie Thoracique Nouvel Hôpital Civl Hôpitaux Univesitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, run by University Hospital, Strasbourg, France 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 5 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 29 Jun 2020. 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 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?
Retrospective description of COVID-19 patients receiving respiratory ECMO-VV supplementation and what happens to them (time frame: Files analysed retrospectily from March 1st, 2020 to April 15, 2020 will be examined). 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 29 Jun 2020.