COVID-19 PneumoniaPROVENT-C19NCT04905875
Prone Positioning for Invasively Ventilated Patients With COVID-19 Registry
An observational study of COVID-19 Pneumonia, run by St. Bortolo Hospital at 1 site in Italy.
Trial summary
SARS-CoV-2 infection is characterized mainly by moderate/severe pneumonia associated with progressive endothelial damage and coagulopathy. Acute respiratory failure among COVID-19 occurs in 42% of patients with COVID-19 pneumonia, and 61-81% of patients requiring intensive care . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Prone Position
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2020to 1 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 18 years and older
- All sexes
- Adult, Older adult
Study population: All critically ill patients undergoing PP in the enrolling centers will be retrospectively and prospectively observed. It should be underlined that the lack of consensus concerning the timing and duration of PP leads to variability in clinical practice and treatments are initiated in accordance with the judgement of the responsible physician. Under these circumstances, it is preferable to keep web-based, multicenter, observational registry" inclusion criteria as wide as possible so as to obtain a real picture of the clinical practice worldwide.
Who may be able to join
- Laboratory-confirmed COVID-19 infection
- Prone positioning in patients admitted to ICU undergoing invasive Mechanical Ventilation
Who cannot join
- Bedsides contraindications to the Prone Positioning and patients in PP but undergoing Non- invasive ventilation should be excluded.
Trial locations and contacts
1 site in 1 country.
Paolo Navalesi, MD contact
Italy1 site, 1 recruiting
- Recruiting
Silvia De Rosa
Vicenza, 36100
Silvia De Rosa, 3933098583, derosa.silvia@ymail.com
About this study
Official title: Prone Positioning for Invasively Ventilated Patients With COVID-19: an Interactive, Web-based, Multicenter, Observational Registry
SARS-CoV-2 infection is characterized mainly by moderate/severe pneumonia associated with progressive endothelial damage and coagulopathy. Acute respiratory failure among COVID-19 occurs in 42% of patients with COVID-19 pneumonia, and 61-81% of patients requiring intensive care . Among the suggested treatments for the management of ARDS patients, prone position (PP) can be used as an adjuvant therapy for improving ventilation in these patients, as recommended in the Surviving Sepsis Campaign COVID-19 guidelines. Nevertheless, no data is currently available on application and feasibility of PP in invasively ventilated patients with COVID-19 on their outcomes.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Prone Position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone PositionProcedure or surgery
Every center will prescribe PP in accordance with local practice and local levels of expertise. No variation in treatment prescription and/or treatment solutions will derive from participation in this prospective observational study. Nonetheless, every setting parameter will be recorded in the web-based registry and analyzed a-posteriori to reveal a potential correlation with the patient outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients with COVID-19 | n centres that obtained IRB approval for this prospective study, all critically ill adult patients (>18yrs) undergoing PP - that are homogeneous in terms of both clinical and treatment characteristics - will be prospectively observed. Receives: Procedure: Prone Position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the subpopulation of critically ill patients that most benefits from prone positioning their intermediate surrogate endpoints. Identification of the subpopulation of critically ill patients with COVID-19 that most benefits from
This subpopulation will be described using the baseline variables associated with a positive long-term patient's outcome. In particular baseline variables statistically associated through multivariable regression analyses with the patient's survival at hospital discharge will be identified and expressed with their Odds ratios, 95%CI and p-value
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Description of the over-time variation of clinical variables during prone positioning
this over-time variation will be expressed, for each variable, as a percentage variation compared with the baseline value (at the prone position initiation).static compliance of the respiratoty system will be assessed
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Dec 2020
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies 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
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Bortolo Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia De Rosa, St. Bortolo Hospital
- Investigators
- Silvia De Rosa, Principal investigator, Ospedale San Bortolo di Vicenza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905875
- Sponsor's protocol ID
- 22/21
- Acronym
- PROVENT-C19
- Status last verified
- May 2021
- First submitted
- 24 May 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lucchini A, Bambi S, Mattiussi E, Elli S, Villa L, Bondi H, Rona R, Fumagalli R, Foti G. Prone Position in Acute Respiratory Distress Syndrome Patients: A Retrospective Analysis of Complications. Dimens Crit Care Nurs. 2020 Jan/Feb;39(1):39-46. doi: 10.1097/DCC.0000000000000393.
PubMed 31789984Carsetti A, Damia Paciarini A, Marini B, Pantanetti S, Adrario E, Donati A. Prolonged prone position ventilation for SARS-CoV-2 patients is feasible and effective. Crit Care. 2020 May 15;24(1):225. doi: 10.1186/s13054-020-02956-w. No abstract available.
PubMed 32414420Coppo A, Bellani G, Winterton D, Di Pierro M, Soria A, Faverio P, Cairo M, Mori S, Messinesi G, Contro E, Bonfanti P, Benini A, Valsecchi MG, Antolini L, Foti G. Feasibility and physiological effects of prone positioning in non-intubated patients with acute respiratory failure due to COVID-19 (PRON-COVID): a prospective cohort study. Lancet Respir Med. 2020 Aug;8(8):765-774. doi: 10.1016/S2213-2600(20)30268-X. Epub 2020 Jun 19.
PubMed 32569585De Rosa S, Sella N, Rezoagli E, Lorenzoni G, Gregori D, Bellani G, Foti G, Pettenuzzo T, Baratto F, Fullin G, Papaccio F, Peta M, Poole D, Toffoletto F, Maggiore SM, Navalesi P; SIAARTI Study Group. The PROVENT-C19 registry: A study protocol for international multicenter SIAARTI registry on the use of prone positioning in mechanically ventilated patients with COVID-19 ARDS. PLoS One. 2022 Dec 30;17(12):e0276261. doi: 10.1371/journal.pone.0276261. eCollection 2022.
PubMed 36584022
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Positioning for Invasively Ventilated Patients With COVID-19: an Interactive, Web-based, Multicenter, Observational Registry
- ClinicalTrials.gov ID
- NCT04905875
- Acronym / sponsor ID
- PROVENT-C19 / 22/21
- Conditions
- COVID-19 Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- St. Bortolo HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 28 May 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.
SARS-CoV-2 infection is characterized mainly by moderate/severe pneumonia associated with progressive endothelial damage and coagulopathy. Acute respiratory failure among COVID-19 occurs in 42% of patients with COVID-19 pneumonia, and 61-81% of patients requiring intensive care . Among the suggested treatments for the management of ARDS patients, prone position (PP) can be used as an adjuvant therapy for improving ventilation in these patients, as recommended in the Surviving Sepsis Campaign COVID-19 guidelines. Nevertheless, no data is currently available on application and feasibility of PP in invasively ventilated patients with COVID-19 on their outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients with COVID-19 | – | Procedure: Prone Positionn centres that obtained IRB approval for this prospective study, all critically ill adult patients (>18yrs) undergoing PP - that are homogeneous in terms of both clinical and treatment characteristics - will be prospectively observed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All critically ill patients undergoing PP in the enrolling centers will be retrospectively and prospectively observed. It should be underlined that the lack of consensus concerning the timing and duration of PP leads to variability in clinical practice and treatments are initiated in accordance with the judgement of the responsible physician. Under these circumstances, it is preferable to keep web-based, multicenter, observational registry" inclusion criteria as wide as possible so as to obtain a real picture of the clinical practice worldwide.
Key inclusion criteria (2 listed)
- Laboratory-confirmed COVID-19 infection
- Prone positioning in patients admitted to ICU undergoing invasive Mechanical Ventilation
Key exclusion criteria (1 listed)
- Bedsides contraindications to the Prone Positioning and patients in PP but undergoing Non- invasive ventilation should be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prone PositionEvery center will prescribe PP in accordance with local practice and local levels of expertise. No variation in treatment prescription and/or treatment solutions will derive from participation in this prospective observational study. Nonetheless, every setting parameter will be recorded in the web-based registry and analyzed a-posteriori to reveal a potential correlation with the patient outcomes. | Procedure or surgery | Critically ill patients with COVID-19 |
Primary outcome
Identification of the subpopulation of critically ill patients that most benefits from prone positioning their intermediate surrogate endpoints. Identification of the subpopulation of critically ill patients with COVID-19 that most benefits from
Time frame: through study completion, an average of 1 year
This subpopulation will be described using the baseline variables associated with a positive long-term patient's outcome. In particular baseline variables statistically associated through multivariable regression analyses with the patient's survival at hospital discharge will be identified and expressed with their Odds ratios, 95%CI and p-value
1 secondary outcome
Description of the over-time variation of clinical variables during prone positioning
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Results publication: PubMed 31789984Lucchini A, Bambi S, Mattiussi E, Elli S, Villa L, Bondi H, Rona R, Fumagalli R, Foti G. Prone Position in Acute Respiratory Distress Syndrome Patients: A Retrospective Analysis of Complications. Dimens Crit Care Nurs. 2020 Jan/Feb;39(1):39-46. doi: 10.1097/DCC.0000000000000393.
- Results publication: PubMed 32414420Carsetti A, Damia Paciarini A, Marini B, Pantanetti S, Adrario E, Donati A. Prolonged prone position ventilation for SARS-CoV-2 patients is feasible and effective. Crit Care. 2020 May 15;24(1):225. doi: 10.1186/s13054-020-02956-w. No abstract available.
- Results publication: PubMed 32569585Coppo A, Bellani G, Winterton D, Di Pierro M, Soria A, Faverio P, Cairo M, Mori S, Messinesi G, Contro E, Bonfanti P, Benini A, Valsecchi MG, Antolini L, Foti G. Feasibility and physiological effects of prone positioning in non-intubated patients with acute respiratory failure due to COVID-19 (PRON-COVID): a prospective cohort study. Lancet Respir Med. 2020 Aug;8(8):765-774. doi: 10.1016/S2213-2600(20)30268-X. Epub 2020 Jun 19.
- Derived from this study: PubMed 36584022De Rosa S, Sella N, Rezoagli E, Lorenzoni G, Gregori D, Bellani G, Foti G, Pettenuzzo T, Baratto F, Fullin G, Papaccio F, Peta M, Poole D, Toffoletto F, Maggiore SM, Navalesi P; SIAARTI Study Group. The PROVENT-C19 registry: A study protocol for international multicenter SIAARTI registry on the use of prone positioning in mechanically ventilated patients with COVID-19 ARDS. PLoS One. 2022 Dec 30;17(12):e0276261. doi: 10.1371/journal.pone.0276261. eCollection 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for COVID-19 Pneumonia
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
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.
Paolo Navalesi, MD contact
Silvia De Rosa principal investigator
Ospedale San Bortolo di Vicenza
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 COVID-19 Pneumonia, run by St. Bortolo Hospital 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 2 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: status not confirmed, as of the sponsor's last update on 1 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia De Rosa, MD (+393933098583, derosa.silvia@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of the subpopulation of critically ill patients that most benefits from prone positioning their intermediate surrogate endpoints. Identification of the subpopulation of critically ill patients with COVID-19 that most benefits from (time frame: through study completion, an average of 1 year). 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 NCT04905875, which also lists 4 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 1 Jun 2021.