Acute Respiratory Distress SyndromePRoVENT-COPNCT05650957
PRactice of VENTilation in Patients With ARDS Due to COVID-19 vs Pneumonia
An observational study of Acute Respiratory Distress Syndrome and COVID-19, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 6 sites in 5 countries.
Trial summary
This study aims to compare epidemiology, management of invasive ventilation and outcomes in critically ill patients with COVID-19 ARDS and ARDS from another pulmonary infection. The investigators will use individual patient data from four recently published large observational COVID-9 studies, including the 'Practice… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, COVID-19, Pneumonia
- How many people
- 7,145 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 1 Aug 2022to 1 Feb 2024
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult critically ill patients receiving invasive ventilation due to ARDS caused by COVID -19 or a pulmonary infection from another origen.
Who may be able to join
- Cause for ARDS is COVID -19 (confirmed with polymerase chain reaction (PCR) and/or presence of typical abnormalities on chest computer tomography (CT) and/or X-ray) or a pulmonary infection from another origen
- Meeting a Berlin criteria for ARDS
- Invasive ventilation
Who cannot join
- Age < 18 years
- Any form of non-invasive ventilation
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Brazil2 sites
Hospital Sirio-Libanes
São Paulo
Univeristy of São Paulo
São Paulo
Argentina1 site
Hospital Interzonal General de Agudos'General Jose de San Martin'
La Plata
Netherlands1 site
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam
About this study
Official title: PRactice of VENTilation in Patients With ARDS Due to COVID-19 Versus ARDS Due to Other Pulmonary Infections (PRoVENT-COP)
This study aims to compare epidemiology, management of invasive ventilation and outcomes in critically ill patients with COVID-19 ARDS and ARDS from another pulmonary infection. The investigators will use individual patient data from four recently published large observational COVID-9 studies, including the 'Practice of VENTilation in COVID-19 patients' (PRoVENT-COVID) study, the 'Epidemiology of COVID-19 patients in the ICU' (EPICCoV) study, the 'SATI-COVID-19 - Clinical Characteristics and Outcomes of Patients With COVID-19 on Mechanical Ventilation in Argentina: a Prospective, Multicenter Cohort Study' and the CIBERESUCICOVID - Personalized Risk and Prognosis Factors and Follow-up at One Year of the Patients Hospitalized in the Spanish Intensive Care Units Infected with COVID -19' study. The investigators will use the individual patient data from ARDS patients with another pulmonary infection from the 'LUNG -SAFE - Large Observational Study to UNderstand the Global Impact of Severe Acute Respiratory FailurE' study and the 'ERICC - Epidemiology of Respiratory Insufficiency in Critical Care' study.
Read the detailed description
Early on in the pandemic, it was frequently proposed that ARDS caused by COVID-19 and ARDS caused by another cause were distinct in a number of ways. COVID-19 related ARDS phenotypes have been suggested, based on differences in respiratory system compliance (Crs) and the severity of the hypoxemia. Other reports have even suggested that lung-protective ventilation strategies for patients with ARDS caused by COVID-19 should differ from those used before the pandemic.
The use of low tidal volumes (VT) and prone positioning, which have been shown to be useful in reducing death in patients with ARDS prior to the pandemic, were also shown to be effective in patients with COVID-19 related ARDS, according to several reports. In the discussion of how to ventilate patients with COVID-19 related ARDS, the disagreement over other ventilatory settings, such as the best positive end-expiratory pressure (PEEP) and the use of recruitment manoeuvres, remains remarkably lively.
To compare epidemiology, management of invasive ventilation and outcomes in critically ill patients with COVID-19 ARDS and ARDS from another pulmonary infection, the investigators will use individual patient data from PRoVENT-COVID, EPICCoV, SATI-COVID-19, CIBERESUCICOVID, LUNG-SAFE and ERICC.
- Conditions
- Acute Respiratory Distress Syndrome, COVID-19, Pneumonia, Mechanical Ventilation Complication
- Keywords
- Mechanical ventilation, Acute Respiratory Distress Syndrome, Ventilation practice, Pulmonary infection, COVID-19
- Medical subject headings
- Respiratory Distress Syndrome, COVID-19, Pneumonia
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 |
|---|---|---|
| Non-COVID-19 ARDS | To be included in this analysis the cause for ARDS was a pulmonary infection other than COVID-19 and meeting all aspects of the Berlin definition. | |
| COVID-19 ARDS | To be included in this analysis the cause for ARDS was COVID-19 and meeting all aspects of the Berlin definition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of invasive ventilation
A combination of key ventilation characteristics, including tidal volume (VT); positive end-expiratory pressure (PEEP); fraction inspired oxygen (FiO2); peak pressure (Ppeak) and plateau pressure (Pplat); respiratory rate (RR); driving pressure (ΔP); respiratory system compliance (CRS) and mechanical power of ventilation (MP).
Measured: Day 1
Secondary outcomes (5)
Ventilator-free days
Liberated of invasive ventilation and alive
Measured: 28 days
Incidence of ICU mortality
Incidence of ICU mortality at day 28 and at day 90
Measured: 90 days
Incidence of in-hospital mortality
Incidence of in-hospital mortality at day 28 and at day 90
Measured: 90 days
ICU length of stay
ICU length of stay at day 28 and at day 90
Measured: 90 days
Hospital length of stay
Hospital length of stay at day 28 and at day 90
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 posted14 Dec 2022
- Study start1 Aug 2022
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Retrospective
- Enrolment
- 7,145 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute, University of Sao Paulo, National University of Ireland, Galway, Ireland, Amsterdam UMC
- Responsible party
- Principal investigator, Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- David MP van Meenen, PhD, Study chair, Amsterdam UMC, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650957
- Sponsor's protocol ID
- AUMC
- Acronym
- PRoVENT-COP
- Status last verified
- Jul 2024
- First submitted
- 13 Dec 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The database will be available after publication of the main publication upon reasonable request after consent of the steering committee. Request must be accompanied by a statistical analysis plan.
Publications
Dorland G, Blok SG, Swart P, van der Ven FLIM, Hollmann MW, Azevedo LC, Bellani G, Botta M, Estenssoro E, Fan E, Ferreira JC, Laffey JG, Martin-Loeches I, Motos A, Pham T, Penuelas O, Pesenti A, Pisani L, Neto AS, Schultz MJ, Torres A, Tsonas AM, Paulus F, Hemmes SNT, van Meenen DMP; ERICC-investigators; LUNG SAFE-investigators; PRoVENT-COVID-investigators; EPICCoV-investigators; CIBERESUCICOVID-investigators; SATI-COVID-19-investigators. Potentially modifiable ventilatory factors contributing to outcome in patients with pulmonary and extrapulmonary ARDS - An individual patient data analysis. J Clin Anesth. 2026 Mar;110:112120. doi: 10.1016/j.jclinane.2025.112120. Epub 2026 Feb 17.
PubMed 41707405van der Ven FLIM, Blok SG, Azevedo LC, Bellani G, Botta M, Estenssoro E, Fan E, Ferreira JC, Laffey JG, Martin-Loeches I, Motos A, Pham T, Penuelas O, Pesenti A, Pisani L, Neto AS, Schultz MJ, Torres A, Tsonas AM, Paulus F, van Meenen DMP; and for the ERICC-; LUNG SAFE-; PRoVENT-COVID-; EPICCoV-; CIBERESUCICOVID-; SATI-COVID-19-investigators. Epidemiology, ventilation management and outcomes of COVID-19 ARDS patients versus patients with ARDS due to pneumonia in the Pre-COVID era. Respir Res. 2024 Aug 17;25(1):312. doi: 10.1186/s12931-024-02910-2.
PubMed 39153979
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRactice of VENTilation in Patients With ARDS Due to COVID-19 Versus ARDS Due to Other Pulmonary Infections (PRoVENT-COP)
- ClinicalTrials.gov ID
- NCT05650957
- Acronym / sponsor ID
- PRoVENT-COP / AUMC
- Conditions
- Acute Respiratory Distress Syndrome, COVID-19, Pneumonia, Mechanical Ventilation Complication
- Keywords
- Mechanical ventilation, Acute Respiratory Distress Syndrome, Ventilation practice, Pulmonary infection, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,145 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Carlos III Health Institute, University of Sao Paulo, National University of Ireland, Galway, Ireland, Amsterdam UMC
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 14 Dec 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.
This study aims to compare epidemiology, management of invasive ventilation and outcomes in critically ill patients with COVID-19 ARDS and ARDS from another pulmonary infection. The investigators will use individual patient data from four recently published large observational COVID-9 studies, including the 'Practice of VENTilation in COVID-19 patients' (PRoVENT-COVID) study, the 'Epidemiology of COVID-19 patients in the ICU' (EPICCoV) study, the 'SATI-COVID-19 - Clinical Characteristics and Outcomes of Patients With COVID-19 on Mechanical Ventilation in Argentina: a Prospective, Multicenter Cohort Study' and the CIBERESUCICOVID - Personalized Risk and Prognosis Factors and Follow-up at One Year of the Patients Hospitalized in the Spanish Intensive Care Units Infected with COVID -19' study. The investigators will use the individual patient data from ARDS patients with another pulmonary infection from the 'LUNG -SAFE - Large Observational Study to UNderstand the Global Impact of Severe Acute Respiratory FailurE' study and the 'ERICC - Epidemiology of Respiratory Insufficiency in Critical Care' study.
Detailed description
Early on in the pandemic, it was frequently proposed that ARDS caused by COVID-19 and ARDS caused by another cause were distinct in a number of ways. COVID-19 related ARDS phenotypes have been suggested, based on differences in respiratory system compliance (Crs) and the severity of the hypoxemia. Other reports have even suggested that lung-protective ventilation strategies for patients with ARDS caused by COVID-19 should differ from those used before the pandemic.
The use of low tidal volumes (VT) and prone positioning, which have been shown to be useful in reducing death in patients with ARDS prior to the pandemic, were also shown to be effective in patients with COVID-19 related ARDS, according to several reports. In the discussion of how to ventilate patients with COVID-19 related ARDS, the disagreement over other ventilatory settings, such as the best positive end-expiratory pressure (PEEP) and the use of recruitment manoeuvres, remains remarkably lively.
To compare epidemiology, management of invasive ventilation and outcomes in critically ill patients with COVID-19 ARDS and ARDS from another pulmonary infection, the investigators will use individual patient data from PRoVENT-COVID, EPICCoV, SATI-COVID-19, CIBERESUCICOVID, LUNG-SAFE and ERICC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-COVID-19 ARDS | – | –To be included in this analysis the cause for ARDS was a pulmonary infection other than COVID-19 and meeting all aspects of the Berlin definition. |
| COVID-19 ARDS | – | –To be included in this analysis the cause for ARDS was COVID-19 and meeting all aspects of the Berlin definition. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients receiving invasive ventilation due to ARDS caused by COVID -19 or a pulmonary infection from another origen.
Key inclusion criteria (3 listed)
- Cause for ARDS is COVID -19 (confirmed with polymerase chain reaction (PCR) and/or presence of typical abnormalities on chest computer tomography (CT) and/or X-ray) or a pulmonary infection from another origen
- Meeting a Berlin criteria for ARDS
- Invasive ventilation
Key exclusion criteria (2 listed)
- Age < 18 years
- Any form of non-invasive ventilation
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
Characteristics of invasive ventilation
Time frame: Day 1
A combination of key ventilation characteristics, including tidal volume (VT); positive end-expiratory pressure (PEEP); fraction inspired oxygen (FiO2); peak pressure (Ppeak) and plateau pressure (Pplat); respiratory rate (RR); driving pressure (ΔP); respiratory system compliance (CRS) and mechanical power of ventilation (MP).
5 secondary outcomes
Ventilator-free days
Time frame: 28 days
Incidence of ICU mortality
Time frame: 90 days
Incidence of in-hospital mortality
Time frame: 90 days
ICU length of stay
Time frame: 90 days
Hospital length of stay
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 3 Jul 2024.
- Derived from this study: PubMed 41707405Dorland G, Blok SG, Swart P, van der Ven FLIM, Hollmann MW, Azevedo LC, Bellani G, Botta M, Estenssoro E, Fan E, Ferreira JC, Laffey JG, Martin-Loeches I, Motos A, Pham T, Penuelas O, Pesenti A, Pisani L, Neto AS, Schultz MJ, Torres A, Tsonas AM, Paulus F, Hemmes SNT, van Meenen DMP; ERICC-investigators; LUNG SAFE-investigators; PRoVENT-COVID-investigators; EPICCoV-investigators; CIBERESUCICOVID-investigators; SATI-COVID-19-investigators. Potentially modifiable ventilatory factors contributing to outcome in patients with pulmonary and extrapulmonary ARDS - An individual patient data analysis. J Clin Anesth. 2026 Mar;110:112120. doi: 10.1016/j.jclinane.2025.112120. Epub 2026 Feb 17.
- Derived from this study: PubMed 39153979van der Ven FLIM, Blok SG, Azevedo LC, Bellani G, Botta M, Estenssoro E, Fan E, Ferreira JC, Laffey JG, Martin-Loeches I, Motos A, Pham T, Penuelas O, Pesenti A, Pisani L, Neto AS, Schultz MJ, Torres A, Tsonas AM, Paulus F, van Meenen DMP; and for the ERICC-; LUNG SAFE-; PRoVENT-COVID-; EPICCoV-; CIBERESUCICOVID-; SATI-COVID-19-investigators. Epidemiology, ventilation management and outcomes of COVID-19 ARDS patients versus patients with ARDS due to pneumonia in the Pre-COVID era. Respir Res. 2024 Aug 17;25(1):312. doi: 10.1186/s12931-024-02910-2.
- Individual participant dataSharing planned: Yes. The database will be available after publication of the main publication upon reasonable request after consent of the steering committee. Request must be accompanied by a statistical analysis plan.
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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.
David MP van Meenen, PhD study chair
Amsterdam UMC, location AMC
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome and COVID-19, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 6 sites in 5 countries.
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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil, Argentina, Ireland, Netherlands, Spain. 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?
Characteristics of invasive ventilation (time frame: Day 1). 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 NCT05650957, which also lists 2 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 3 Jul 2024.