Covid19PRINCESSNCT04649658
Pronation in COVID-19 Patients Undergoing Non Invasive Respiratory Support
An observational study of Covid19, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial summary
Pronation seems feasible and effective in improving blood oxygenation in patients with COVID-19 pneumonia. Data are lacking on the effects of pronation on clinical outcome in this subset of patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19
- What is being tested?
- Prone position
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 93 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2020to 30 Nov 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients aged ≥18 and < 80 years old admitted to the two respiratory intensive care units for severe and critical COVID-19 pneumonia between March 1st, 2020 and June 1st, 2020.
Who may be able to join
- patients aged ≥18 and < 80 years old
- acute respiratory failure
Who cannot join
- endotracheal intubation performed within the first 24 hours from admission,
- ceiling of escalation of intensive care
- do not intubate order as expressed by patient willing or upon clinical judgement
- missing core data at medical record analysis (clinical features at baseline, pronation information, type and time of ventilatory support required, mortality, need for tracheostomy, length of respiratory intensive care unit and hospital stay).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Awake Prone Position in Critical and Severe COVID-19 Patients Undergoing Noninvasive Respiratory Support: a Retrospective Multicenter Cohort Study
Pronation seems feasible and effective in improving blood oxygenation in patients with COVID-19 pneumonia. Data are lacking on the effects of pronation on clinical outcome in this subset of patients.
- Conditions
- Covid19
- Being tested
- Prone position
- Keywords
- Spontaneous breathing, Awake pronation, COVID-19, Respiratory failure
- Medical subject headings
- COVID-19, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone positionBehavioural
Prone position maintained at least 3 hours/day
| Study group | Role | What they receive |
|---|---|---|
| Prone position | Severe and critical COVID-19 patients undergoing non invasive respiratory support subjected to prone position Receives: Behavioral: Prone position | |
| Standard care | Severe and critical COVID-19 patients undergoing non invasive respiratory support subjected to standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotracheal intubation
Measured: 28 days
Secondary outcomes (4)
Mortality
Measured: 28 days
Tracheostomy
Measured: 28 days
Length of Respiratory Intensive Care Unit stay
Measured: 60 days
Length of Hospital stay
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Mar 2020
- Primary completion1 Jun 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Tonelli, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649658
- Sponsor's protocol ID
- UModenaReggio10
- Acronym
- PRINCESS
- Status last verified
- Dec 2020
- First submitted
- 30 Nov 2020
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awake Prone Position in Critical and Severe COVID-19 Patients Undergoing Noninvasive Respiratory Support: a Retrospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT04649658
- Acronym / sponsor ID
- PRINCESS / UModenaReggio10
- Conditions
- Covid19
- Keywords
- Spontaneous breathing, Awake pronation, COVID-19, Respiratory failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 2 Dec 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.
Pronation seems feasible and effective in improving blood oxygenation in patients with COVID-19 pneumonia. Data are lacking on the effects of pronation on clinical outcome in this subset of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone position | – | Behavioral: Prone positionSevere and critical COVID-19 patients undergoing non invasive respiratory support subjected to prone position |
| Standard care | – | –Severe and critical COVID-19 patients undergoing non invasive respiratory support subjected to standard care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients aged ≥18 and < 80 years old admitted to the two respiratory intensive care units for severe and critical COVID-19 pneumonia between March 1st, 2020 and June 1st, 2020.
Key inclusion criteria (2 listed)
- patients aged ≥18 and < 80 years old
- acute respiratory failure
Key exclusion criteria (4 listed)
- endotracheal intubation performed within the first 24 hours from admission,
- ceiling of escalation of intensive care
- do not intubate order as expressed by patient willing or upon clinical judgement
- missing core data at medical record analysis (clinical features at baseline, pronation information, type and time of ventilatory support required, mortality, need for tracheostomy, length of respiratory intensive care unit and hospital stay).
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 positionProne position maintained at least 3 hours/day | Behavioural | Prone position |
Primary outcome
Endotracheal intubation
Time frame: 28 days
4 secondary outcomes
Mortality
Time frame: 28 days
Tracheostomy
Time frame: 28 days
Length of Respiratory Intensive Care Unit stay
Time frame: 60 days
Length of Hospital stay
Time frame: 60 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 14 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Covid19
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
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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
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 Covid19, run by University of Modena and Reggio Emilia 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 4 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 14 Dec 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 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?
Endotracheal intubation (time frame: 28 days). 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 14 Dec 2020.