Covid-19 InfectionNCT04667286
Awake Pronation for Covid-19 Treatment
A study testing Prone Position (PP) in people with Covid-19 Infection, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 3 sites in Italy.
Trial summary
Observational studies have shown that prone position (PP) in spontaneously breathing patients, may improve oxygenation in individuals with Acute Respiratory Failure (ARF), due to Covid-19 infection. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Covid-19 Infection
- What is being tested?
- Prone Position (PP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesItaly
- Study dates
- 16 Jan 2021to 1 Jul 2021
- Phase
- Interventional
- 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
Who may be able to join
- confirmed COVID-19 infection using PCR
- Acute Respiratory Failure ( 200 <PaO2/FiO2 <300) and respiratory rate < 30 atti/min
- O2 therapy initiated <72 hrs
- informed consent
Who cannot join
- Glasgow Coma Scale (GCS) < 13
- pH< 7,45, PaCO2 >45 mmHg
- need for HFNC, CPAP, NIV or intubation
- hemodynamic instability increase of 80-90 mmHg or reduction of 30-40 mmHg in systolic blood pressure
- severe arrythmia of myocardial infarction
- need for sedation
Show all 9Show fewer
- intolerance to PP
- pregnancy
- Body mass index (BMI) > 35 kg/m2.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Recruiting
Sant'Orsola Malpighi
Bologna, 40185
Stefano Nava, MD
- Recruiting
Bolzano Hospital
Bolzano
roberto dongilli
- Recruiting
University of Modena
Modena
enrico clini
About this study
Official title: Pronation in Spontaneously Breathing Patients With Acute Respiratory Failure Deu to Covid-19: Multicenter, Randomised Study
Observational studies have shown that prone position (PP) in spontaneously breathing patients, may improve oxygenation in individuals with Acute Respiratory Failure (ARF), due to Covid-19 infection.
None so far have evaluated the clinical efficacy of this approach on the patients' outcomes and in a randomised control fashion
Read the detailed description
Observational studies have shown that prone position (PP) in spontaneously breathing patients, may improve oxygenation in individuals with Acute Respiratory Failure (ARF), due to Covid-19 infection.
These studies were mainly physiological and reported in a subset of patients a poor tolerance. Indeed most of the beneficial effects on gas exchage disappeared in around 40% of tyhe patients, once the patients regained the supine position.
None so far have evaluated the clinical efficacy of this approach on the patients' outcomes and in a randomised control fashion.
This holds particularly true in those patients affected by mild de-novo ARF (PaO2/FiO2 ratio within the range of 200-300), where any form of respiratory support like Continuous Positive Airways Pressure (CPAP), High Flow Nasal Cannula (HFNC) or Noninvasive ventilation (NIV), may be not yet indicated, especially if the patients are admitted to a regular ward as for the case of Covid-19 pandemics, due to the lack of "protected" beds.
- Conditions
- Covid-19 Infection
- Being tested
- Prone Position (PP)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone Position (PP)Procedure or surgery
Prone the patients on oxygen for at least 10 hrs a day
| Study group | Role | What they receive |
|---|---|---|
| Oxygen and Prone Position (PP) | Experimental | Oxygen via a Venturi mask in order to keep an oxygen saturation between 92 and 96% plus PP for a minimum of 10 hrs a day Receives: Procedure: Prone Position (PP) |
| Oxygen | Active comparator | Oxygen via a Venturi mask in order to keep an oxygen saturation between 92 and 96% Receives: Procedure: Prone Position (PP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of day free of ventilatory support
number of days in which the patient will not need (according to standardized criterai) any for of these ventilatory support like NIV,CPAP, HFNC or intubation
Measured: 1 month
Secondary outcomes (4)
changes in respiratory pattern
recording of tidal volume (when possible) and respiratory frequency
Measured: 1 month
daily changes in the ratio SaO2/FiO2
Daily changes in oxygen saturation (SaO2) and Fraction of Inspired Oxygen (FiO2)
Measured: 1 month
dyspnea
using a dedicated scale (i.e. Borg numbered from 0 to 10)
Measured: 1 month
comfort during PP
using a dedicated visual analog scale (VAS with a lenght of 20 cm)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start16 Jan 2021
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19 InfectionStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS, Azienda Ospedaliera di Bolzano, Azienda Ospedaliero-Universitaria di Modena
- Responsible party
- Principal investigator, dr. Stefano Nava, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- stefano nava, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667286
- Sponsor's protocol ID
- 1117/2020/Sper/AOUBo
- Status last verified
- Apr 2021
- First submitted
- 11 Dec 2020
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pronation in Spontaneously Breathing Patients With Acute Respiratory Failure Deu to Covid-19: Multicenter, Randomised Study
- ClinicalTrials.gov ID
- NCT04667286
- Acronym / sponsor ID
- 1117/2020/Sper/AOUBo
- Conditions
- Covid-19 Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS, Azienda Ospedaliera di Bolzano, Azienda Ospedaliero-Universitaria di Modena
- Study start
- 16 Jan 2021 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 14 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.
Observational studies have shown that prone position (PP) in spontaneously breathing patients, may improve oxygenation in individuals with Acute Respiratory Failure (ARF), due to Covid-19 infection.
None so far have evaluated the clinical efficacy of this approach on the patients' outcomes and in a randomised control fashion
Detailed description
Observational studies have shown that prone position (PP) in spontaneously breathing patients, may improve oxygenation in individuals with Acute Respiratory Failure (ARF), due to Covid-19 infection.
These studies were mainly physiological and reported in a subset of patients a poor tolerance. Indeed most of the beneficial effects on gas exchage disappeared in around 40% of tyhe patients, once the patients regained the supine position.
None so far have evaluated the clinical efficacy of this approach on the patients' outcomes and in a randomised control fashion.
This holds particularly true in those patients affected by mild de-novo ARF (PaO2/FiO2 ratio within the range of 200-300), where any form of respiratory support like Continuous Positive Airways Pressure (CPAP), High Flow Nasal Cannula (HFNC) or Noninvasive ventilation (NIV), may be not yet indicated, especially if the patients are admitted to a regular ward as for the case of Covid-19 pandemics, due to the lack of "protected" beds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomised trial
| Arm | Type | Receives |
|---|---|---|
| Oxygen and Prone Position (PP) | Experimental | Procedure: Prone Position (PP)Oxygen via a Venturi mask in order to keep an oxygen saturation between 92 and 96% plus PP for a minimum of 10 hrs a day |
| Oxygen | Active comparator | Procedure: Prone Position (PP)Oxygen via a Venturi mask in order to keep an oxygen saturation between 92 and 96% |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- confirmed COVID-19 infection using PCR
- Acute Respiratory Failure ( 200 <PaO2/FiO2 <300) and respiratory rate < 30 atti/min
- O2 therapy initiated <72 hrs
- informed consent
Key exclusion criteria (9 listed)
- Glasgow Coma Scale (GCS) < 13
- pH< 7,45, PaCO2 >45 mmHg
- need for HFNC, CPAP, NIV or intubation
- hemodynamic instability increase of 80-90 mmHg or reduction of 30-40 mmHg in systolic blood pressure
- severe arrythmia of myocardial infarction
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 Position (PP)Prone the patients on oxygen for at least 10 hrs a day | Procedure or surgery | Oxygen, Oxygen and Prone Position (PP) |
Primary outcome
number of day free of ventilatory support
Time frame: 1 month
number of days in which the patient will not need (according to standardized criterai) any for of these ventilatory support like NIV,CPAP, HFNC or intubation
4 secondary outcomes
changes in respiratory pattern
Time frame: 1 month
daily changes in the ratio SaO2/FiO2
Time frame: 1 month
dyspnea
Time frame: 1 month
comfort during PP
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- 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.
stefano nava, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone Position (PP) in people with Covid-19 Infection, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 3 sites 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 9 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 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 stefano nava (+393333751828, stefanava@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of day free of ventilatory support (time frame: 1 month). 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 19 Apr 2021.