ARDSInfluCOV_ECMONCT05080933
ECMO for COVID-19 vs Influenza A H1N1 Associated ARDS
An observational study of ARDS and COVID-19, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Objective: Veno-venous ECMO has been used as a rescue therapy for patients with severe ARDS associated to influenza A H1N1 and COVID19 viral pneumonia. Little is known about outcome of these patients who required extracorporeal support. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ARDS, COVID-19, H1N1 Influenza
- How many people
- 308 participants
- Where
- 1 siteItaly
- Study dates
- 22 Aug 2009to 28 Feb 2021
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients who required VV ECMO for COVID-19 and influenza A H1N1 associated ARDS
Who may be able to join
- COVID-19 or influenza A H1N1 (suspected or confirmed) diagnosis
- Severe ARDS (according to Berlin Definition)
- VV ECMO
- Invasive mechanical ventilation through endotracheal tube or tracheostomy
Who cannot join
- Age<18 years
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Turin - Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, 10126
About this study
Official title: Extracorporeal Membrane Oxygenation for COVID-19 and Influenza H1N1 Associated Acute Respiratory Distress Syndrome: a Multi-centre Retrospective Cohort Study
Objective: Veno-venous ECMO has been used as a rescue therapy for patients with severe ARDS associated to influenza A H1N1 and COVID19 viral pneumonia. Little is known about outcome of these patients who required extracorporeal support.
Research question: To compare outcome of patients who required VV ECMO for Covid19 and H1N1 associated ARDS
- Conditions
- ARDS, COVID-19, H1N1 Influenza
- Medical subject headings
- COVID-19, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 | Not described | |
| H1N1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality on day 60 after ECMO initiation
Measured: 60 days
Secondary outcomes (9)
Hospital length of stay
Measured: 90 days
ICU length of stay
Measured: 90 days
Hospital mortality on day 90 after ECMO initiation
Measured: 90 days
ECMO duration
Measured: 90 days
ECMO associated hemorrhagic complications
Measured: 60 days
ECMO associated mechanical complications
Measured: 60 days
Invasive mechanical ventilation duration
Measured: 90 days
ECMO related haemorrhagic complications
Measured: 90 days
ECMO related mechanical complications
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start22 Aug 2009
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vito Fanelli MD, PhD, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080933
- Sponsor's protocol ID
- v1_12_2020
- Acronym
- InfluCOV_ECMO
- Status last verified
- Oct 2021
- First submitted
- 15 Oct 2021
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fanelli V, Giani M, Grasselli G, Mojoli F, Martucci G, Grazioli L, Alessandri F, Mongodi S, Sales G, Montrucchio G, Pizzi C, Richiardi L, Lorini L, Arcadipane A, Pesenti A, Foti G, Patroniti N, Brazzi L, Ranieri V. Extracorporeal membrane oxygenation for COVID-19 and influenza H1N1 associated acute respiratory distress syndrome: a multicenter retrospective cohort study. Crit Care. 2022 Feb 5;26(1):34. doi: 10.1186/s13054-022-03906-4.
PubMed 35123562
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Membrane Oxygenation for COVID-19 and Influenza H1N1 Associated Acute Respiratory Distress Syndrome: a Multi-centre Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05080933
- Acronym / sponsor ID
- InfluCOV_ECMO / v1_12_2020
- Conditions
- ARDS, COVID-19, H1N1 Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 22 Aug 2009 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 18 Oct 2021 (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.
Objective: Veno-venous ECMO has been used as a rescue therapy for patients with severe ARDS associated to influenza A H1N1 and COVID19 viral pneumonia. Little is known about outcome of these patients who required extracorporeal support.
Research question: To compare outcome of patients who required VV ECMO for Covid19 and H1N1 associated ARDS
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | – |
| H1N1 | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who required VV ECMO for COVID-19 and influenza A H1N1 associated ARDS
Key inclusion criteria (4 listed)
- COVID-19 or influenza A H1N1 (suspected or confirmed) diagnosis
- Severe ARDS (according to Berlin Definition)
- VV ECMO
- Invasive mechanical ventilation through endotracheal tube or tracheostomy
Key exclusion criteria (1 listed)
- Age<18 years
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
All cause mortality on day 60 after ECMO initiation
Time frame: 60 days
9 secondary outcomes
Hospital length of stay
Time frame: 90 days
ICU length of stay
Time frame: 90 days
Hospital mortality on day 90 after ECMO initiation
Time frame: 90 days
ECMO duration
Time frame: 90 days
ECMO associated hemorrhagic complications
Time frame: 60 days
ECMO associated mechanical complications
Time frame: 60 days
Invasive mechanical ventilation duration
Time frame: 90 days
ECMO related haemorrhagic complications
Time frame: 90 days
ECMO related mechanical complications
Time frame: 90 days
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 18 Oct 2021.
- Derived from this study: PubMed 35123562Fanelli V, Giani M, Grasselli G, Mojoli F, Martucci G, Grazioli L, Alessandri F, Mongodi S, Sales G, Montrucchio G, Pizzi C, Richiardi L, Lorini L, Arcadipane A, Pesenti A, Foti G, Patroniti N, Brazzi L, Ranieri V. Extracorporeal membrane oxygenation for COVID-19 and influenza H1N1 associated acute respiratory distress syndrome: a multicenter retrospective cohort study. Crit Care. 2022 Feb 5;26(1):34. doi: 10.1186/s13054-022-03906-4.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 ARDS and COVID-19, run by University of Turin, Italy at 1 site in Italy.
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 4 inclusion and 1 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 18 Oct 2021. 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 Italy. 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?
All cause mortality on day 60 after ECMO initiation (time frame: 60 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 NCT05080933, which also lists 1 linked publication.
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 18 Oct 2021.