COVID19PROVID-19NCT04363463
Impact of Prone Position in Patients Under Spontaneous Breathing on Intubation or Non-invasive Ventilation or Death Incidence During COVID-19 Acute Respiratory Distress
A study testing prone position in people with COVID19 and Oxygen Therapy, run by Centre Hospitalier Régional d'Orléans at 19 sites in 2 countries.
Trial summary
The SARS-Cov2 viral pandemic is responsible for a new infectious disease called COVID-19 (CoronaVIrus Disease), is a major health problem. Respiratory complications occur in 15 to 40%, the most serious is acute respiratory distress syndrome (ARDS). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COVID19, Oxygen Therapy, Prone Position
- What is being tested?
- prone position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 28 Aug 2020to 13 Jan 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged from 18 to 85 years old
- With COVID-19 documentation
- Undergoing oxygen therapy (nasal cannula, medium or high concentration mask or high flow nasal oxygen therapy)
- Able to move to PP by him/herself or with minimal assistance
- Written consent
- Hospitalized in COVID medical department for less than 72 hours
Who cannot join
- Pregnant (positive pregnancy test during screening) or breastfeeding women
- Patient on long-term oxygen therapy or Continuous Positive Airway Pressure (CPAP) or Non-Invasive Ventilation (NIV) at home
- Chronic Obstructive Pulmonary Disease (COPD) Patient stage 3 or 4
- Patient with known chronic diffuse interstitial lung disease
- Patient with neuromuscular pathology
- Contraindication to the PP (recent thoracic trauma, pneumothorax, orthopaedic fracture preventing mobilization, ...)
Show all 19Show fewer
- Deep vein thrombosis of the lower limbs or pulmonary embolism with effective anticoagulation for less than 48 hours
- Hemodynamic instability (MAP < 65 mm Hg) persisting for more than 1 hour
- Respiratory rate greater than 40 cycles per minute
- Excessive use of accessory respiratory muscles (as judged by the clinician)
- Indication for curative NIV (acute pulmonary edema or acute hypercapnic respiratory failure)
- Intestinal Occlusive Syndrome
- Patient unable to protect upper airway
- Inability to understand French or to follow instructions for the prone position.
- Person under guardianship
- Protected Majors
- Not affiliated to French social security
- Decision not to forgo life sustaining therapy
- Patient discharged from an intensive care unit and has been treated by invasive or non-invasive mechanical ventilation at 2 pressure levels during the resuscitation stay.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
France18 sites
CH de Blois
Blois, 41016
CH de DAX
Dax, 40100
CHD de VENDEE
La Roche-sur-Yon, 85925
CH de LA ROCHELLE
La Rochelle, 17019
CH Le Mans
Le Mans, 72037
CH Mont de MArsan
Mont-de-Marsan, 40012
CHR d'Orléans - Service Pneumologie
Orléans, 45000
CHR d'Orleans - Service Maladies Infectieuses
Orléans, 45067
HOPITAL LARIBOISIERE - Service diabétologie, endocrinologie, nutrition
Paris, 75010
Hopital Européen Georges Pompidou
Paris
Hopital Lariboisiere - Medecine Interne
Paris
Hopital Lariboisiere
Paris
CH de PERPIGNAN - Service Maladies infectieuses
Perpignan, 66046
Centre Hospitalier Intercommunal de Cornouaille - Quimper Concarneau
Quimper, 29000
CHRU de Tours - Service Médecine interne et immunologie Clinique
Tours, 37000
CHRU de Tours - Service Pneumologie
Tours, 37000
CHRU DE TOURS - Service Médecine interne et maladies infectieuses
Tours, 37044
CH Bretagne Atlantique
Vannes, 56017
About this study
The SARS-Cov2 viral pandemic is responsible for a new infectious disease called COVID-19 (CoronaVIrus Disease), is a major health problem. Respiratory complications occur in 15 to 40%, the most serious is acute respiratory distress syndrome (ARDS).
The management of COVID-19 is essentially symptomatic with respiratory oxygen supplementation in mild forms to invasive mechanical ventilation in the most severe forms.
Read more
Prone position (PP) reduced mortality in patients with ARDS in intensive care. Ding et al showed that PP and high flow oxygenation reduced the intubation in patients with moderate to severe ARDS.
The investigators hypothesize that the use of PP in spontaneously ventilation patients under oxygen standard could decrease incidence of intubation or non-invasive ventilation or death compared to conventional positioning management in medical departments.
Read the detailed description
This is a multicenter randomized controlled study. 400 patients with COVID-19 documentation and undergoing oxygen therapy will be randomly assigned, with a 1:1 ratio, to conventional positioning or repeated prone sessions.
The control group will have conventional positioning: semi-seated in bed or seated in a chair. The prone position is not allowed during the day (it is allowed at night if it is the natural sleeping position).
The intervention group will have:
- Two sessions minimum of prone position over the day. With a total objective of at least 2h30 of cumulated duration over the day. The objective is to spend as much time as possible in prone position if the patient tolerates it well.
- The maximum of prone position at night. Patients must be able to take position by themselves or with minimal assistance. The rails will be positioned in order to prevent falling out of bed. The patient will be free to choose his preferred prone position as long as the back is not compressed
- Conditions
- COVID19, Oxygen Therapy, Prone Position, Spontaneous Ventilation, Respiratory Distress Syndrome
- Being tested
- prone position
- Keywords
- COVID19, Oxygen therapy, Prone position, Spontaneous ventilation, Acute respiratory failure
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prone positionOther
Two sessions minimum of prone position over the day. With a total objective of at least 2h30 of cumulated duration over the day. The objective is to spend as much time as possible in prone position if the patient tolerates it well.
| Study group | Role | What they receive |
|---|---|---|
| Conventional positioning | No intervention | semi-seated in bed or seated in a chair during the day. The prone position is not allowed during the day (it is allowed at night if it is the natural sleeping position). |
| Interventional positioning : prone position | Experimental | Two sessions minimum of prone position over the day. With a total objective of at least 2h30 of cumulated duration over the day. The objective is to spend as much time as possible in prone position if the patient tolerates it well. Receives: Other: prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent age of patients who will have endotracheal intubation or non-invasive ventilation at two pressure levels and/or die, in each of the 2 randomization groups.
To show that PP in spontaneously ventilation patients could reduce the risk of acquiring the following event (composite endpoint):
- Endotracheal intubation
- Or non-invasive ventilation (NIV) with two pressure levels
- And/or death
Measured: Day 28
Secondary outcomes (8)
Duration in days for the change of 2 points on the WHO ordinal scale
Show that the use of prone position improves the WHO ordinal scale score by 2 points faster (after randomization)
Measured: Day 28
Rate (%) of intubation and invasive ventilation in the 2 randomization groups.
Show that prone position with spontaneous ventilation reduces the need for endotracheal intubation and invasive mechanical ventilation
Measured: Day 28
Rate (%) of non-invasive ventilation at two pressure levels in the 2 randomization groups
Show that prone position with spontaneous ventilation reduces the use of non-invasive ventilation at two pressure levels
Measured: Day 28
Duration of oxygen therapy in the 2 randomization groups.
Show that prone position in spontaneous ventilation reduces the time under oxygen therapy.
Measured: Day 28
Duration of hospitalization in the 2 randomization groups.
Show that prone position reduces the length of hospitalization.
Measured: Day 28
Hospital mortality and mortality at D28 in the 2 randomization groups
Compare the hospital mortality of the 2 groups
Measured: Day 28
Rate (%) of need for transfer to intensive care unit
Compare the incidence of the need for resuscitation transfer between the two groups.
Measured: Day 28
Rate (%) of use of non-invasive ventilation at two pressure levels, intubation throughout the entire stay when the stay is longer than 28 days.
Compare the impact of the use of non-invasive ventilation and intubation on the entire hospital stay when the hospital stay is longer than 28 days between the two groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start28 Aug 2020
- Primary completion13 Jan 2022
- Study completion13 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled multicenter trial Ratio 1:1
- Masking
- None (open label)
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mai-Anh NAY, Dr, Study chair, CHR Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363463
- Sponsor's protocol ID
- CHRO-2020-09
- Acronym
- PROVID-19
- Status last verified
- Dec 2022
- First submitted
- 22 Apr 2020
- Last updated
- 28 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Murthy S, Gomersall CD, Fowler RA. Care for Critically Ill Patients With COVID-19. JAMA. 2020 Apr 21;323(15):1499-1500. doi: 10.1001/jama.2020.3633. No abstract available.
PubMed 32159735Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
PubMed 32171076Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.
PubMed 32167524Nay MA, Hindre R, Perrin C, Clement J, Plantier L, Seve A, Druelle S, Morrier M, Laine JB, Colombain L, Corvaisier G, Bizien N, Pouget-Abadie X, Bigot A, Jamard S, Nyamankolly E, Planquette B, Fossat G, Boulain T. Prone position versus usual care in hypoxemic COVID-19 patients in medical wards: a randomised controlled trial. Crit Care. 2023 Jun 17;27(1):240. doi: 10.1186/s13054-023-04529-z.
PubMed 37330512Nay MA, Planquette B, Perrin C, Clement J, Plantier L, Seve A, Druelle S, Morrier M, Laine JB, Colombain L, Corvaisier G, Bizien N, Pouget-Abadie X, Bigot A, Bernard L, Nyamankolly E, Fossat G, Boulain T. Does awake prone positioning prevent the use of mechanical respiratory support or death in COVID-19 patients on standard oxygen therapy hospitalised in general wards? A multicentre randomised controlled trial: the PROVID-19 protocol. BMJ Open. 2022 Jul 8;12(7):e060320. doi: 10.1136/bmjopen-2021-060320.
PubMed 35803621
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prone Position in Patients Under Spontaneous Breathing on Intubation or Non-invasive Ventilation or Death Incidence During COVID-19 Acute Respiratory Distress
- ClinicalTrials.gov ID
- NCT04363463
- Acronym / sponsor ID
- PROVID-19 / CHRO-2020-09
- Conditions
- COVID19, Oxygen Therapy, Prone Position, Spontaneous Ventilation, Respiratory Distress Syndrome
- Keywords
- COVID19, Oxygen therapy, Prone position, Spontaneous ventilation, Acute respiratory failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 13 Jan 2022 (actual)
- First posted
- 27 Apr 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.
The SARS-Cov2 viral pandemic is responsible for a new infectious disease called COVID-19 (CoronaVIrus Disease), is a major health problem. Respiratory complications occur in 15 to 40%, the most serious is acute respiratory distress syndrome (ARDS).
The management of COVID-19 is essentially symptomatic with respiratory oxygen supplementation in mild forms to invasive mechanical ventilation in the most severe forms.
Prone position (PP) reduced mortality in patients with ARDS in intensive care. Ding et al showed that PP and high flow oxygenation reduced the intubation in patients with moderate to severe ARDS.
The investigators hypothesize that the use of PP in spontaneously ventilation patients under oxygen standard could decrease incidence of intubation or non-invasive ventilation or death compared to conventional positioning management in medical departments.
Detailed description
This is a multicenter randomized controlled study. 400 patients with COVID-19 documentation and undergoing oxygen therapy will be randomly assigned, with a 1:1 ratio, to conventional positioning or repeated prone sessions.
The control group will have conventional positioning: semi-seated in bed or seated in a chair. The prone position is not allowed during the day (it is allowed at night if it is the natural sleeping position).
The intervention group will have:
- Two sessions minimum of prone position over the day. With a total objective of at least 2h30 of cumulated duration over the day. The objective is to spend as much time as possible in prone position if the patient tolerates it well.
- The maximum of prone position at night. Patients must be able to take position by themselves or with minimal assistance. The rails will be positioned in order to prevent falling out of bed. The patient will be free to choose his preferred prone position as long as the back is not compressed
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled multicenter trial Ratio 1:1
| Arm | Type | Receives |
|---|---|---|
| Conventional positioning | No intervention | –semi-seated in bed or seated in a chair during the day. The prone position is not allowed during the day (it is allowed at night if it is the natural sleeping position). |
| Interventional positioning : prone position | Experimental | Other: prone positionTwo sessions minimum of prone position over the day. With a total objective of at least 2h30 of cumulated duration over the day. The objective is to spend as much time as possible in prone position if the patient tolerates it well. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged from 18 to 85 years old
- With COVID-19 documentation
- Undergoing oxygen therapy (nasal cannula, medium or high concentration mask or high flow nasal oxygen therapy)
- Able to move to PP by him/herself or with minimal assistance
- Written consent
Key exclusion criteria (19 listed)
- Pregnant (positive pregnancy test during screening) or breastfeeding women
- Patient on long-term oxygen therapy or Continuous Positive Airway Pressure (CPAP) or Non-Invasive Ventilation (NIV) at home
- Chronic Obstructive Pulmonary Disease (COPD) Patient stage 3 or 4
- Patient with known chronic diffuse interstitial lung disease
- Patient with neuromuscular pathology
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 positionTwo sessions minimum of prone position over the day. With a total objective of at least 2h30 of cumulated duration over the day. The objective is to spend as much time as possible in prone position if the patient tolerates it well. | Other | Interventional positioning : prone position |
Primary outcome
Percent age of patients who will have endotracheal intubation or non-invasive ventilation at two pressure levels and/or die, in each of the 2 randomization groups.
Time frame: Day 28
To show that PP in spontaneously ventilation patients could reduce the risk of acquiring the following event (composite endpoint): * Endotracheal intubation * Or non-invasive ventilation (NIV) with two pressure levels * And/or death
8 secondary outcomes
Duration in days for the change of 2 points on the WHO ordinal scale
Time frame: Day 28
Rate (%) of intubation and invasive ventilation in the 2 randomization groups.
Time frame: Day 28
Rate (%) of non-invasive ventilation at two pressure levels in the 2 randomization groups
Time frame: Day 28
Duration of oxygen therapy in the 2 randomization groups.
Time frame: Day 28
Duration of hospitalization in the 2 randomization groups.
Time frame: Day 28
Hospital mortality and mortality at D28 in the 2 randomization groups
Time frame: Day 28
Rate (%) of need for transfer to intensive care unit
Time frame: Day 28
Rate (%) of use of non-invasive ventilation at two pressure levels, intubation throughout the entire stay when the stay is longer than 28 days.
Time frame: 1 year
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 28 Dec 2022.
- Background: PubMed 32159735Murthy S, Gomersall CD, Fowler RA. Care for Critically Ill Patients With COVID-19. JAMA. 2020 Apr 21;323(15):1499-1500. doi: 10.1001/jama.2020.3633. No abstract available.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Background: PubMed 32171076Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
- Background: PubMed 32167524Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.
- Derived from this study: PubMed 37330512Nay MA, Hindre R, Perrin C, Clement J, Plantier L, Seve A, Druelle S, Morrier M, Laine JB, Colombain L, Corvaisier G, Bizien N, Pouget-Abadie X, Bigot A, Jamard S, Nyamankolly E, Planquette B, Fossat G, Boulain T. Prone position versus usual care in hypoxemic COVID-19 patients in medical wards: a randomised controlled trial. Crit Care. 2023 Jun 17;27(1):240. doi: 10.1186/s13054-023-04529-z.
- Derived from this study: PubMed 35803621Nay MA, Planquette B, Perrin C, Clement J, Plantier L, Seve A, Druelle S, Morrier M, Laine JB, Colombain L, Corvaisier G, Bizien N, Pouget-Abadie X, Bigot A, Bernard L, Nyamankolly E, Fossat G, Boulain T. Does awake prone positioning prevent the use of mechanical respiratory support or death in COVID-19 patients on standard oxygen therapy hospitalised in general wards? A multicentre randomised controlled trial: the PROVID-19 protocol. BMJ Open. 2022 Jul 8;12(7):e060320. doi: 10.1136/bmjopen-2021-060320.
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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.
Mai-Anh NAY, Dr study chair
CHR Orléans
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prone position in people with COVID19 and Oxygen Therapy, run by Centre Hospitalier Régional d'Orléans at 19 sites in 2 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 6 inclusion and 19 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 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Monaco. 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?
Percent age of patients who will have endotracheal intubation or non-invasive ventilation at two pressure levels and/or die, in each of the 2 randomization groups. (time frame: Day 28). 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 NCT04363463, which also lists 6 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 28 Dec 2022.