COVIDPROVIDNCT04366856
PROne Positioning in coVID-19 Oxygeno-dependent Patients in Spontaneous Ventilation (PROVID Study)
A study testing 1: Prone positioning and 2: No instruction regarding positioning in people with COVID and ARDS, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The COVID epidemics is responsible for a huge number of death following COVID acute respiratory failure. First instance treatment includes oxygenotherapy up to 15L/min in spontaneous ventilation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- 1: Prone positioning and 2: No instruction regarding positioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2020to 23 Sep 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the hospital
- Laboratory-confirmed SARS-CoV-2 infection as determined by PCR and/or CT scan showing typical radiological findings (ground glass abnormalities)
- Need for O2 3L/min to get an SpO2 higher or equal to 95%.
- Patient able to understand and to get in prone postion themself
- No therapeutic limitation
Who cannot join
- Age > 80 years
- Pregnancy
- Impossibility to get in prone position
Trial locations and contacts
1 site in 1 country.
France1 site
Département d'Anesthésie Réanimation - Kremlin Bicêtre
Le Kremlin-Bicêtre, 94270
About this study
The COVID epidemics is responsible for a huge number of death following COVID acute respiratory failure. First instance treatment includes oxygenotherapy up to 15L/min in spontaneous ventilation. However COVID infection can ultimately lead to an acute respiratory distress syndrome (ARDS) requiring mechanical ventilation in the intensive care unit (ICU). Guidelines on ARDS management are based on small ventilation volume (6 mL/kg), a pulmonary end expiratory pressure (PEEP) chosen to get the best pulmonary compliance, a plateau pressure lower than 30 cm of water and daily prone positioning when PaO2/FiO2 ratio is lower than 150. In ventilated ARDS patients, prone positioning has shown survival improvement. Though they applied this optimized management of ARDS patients, Chinese intensivists have recently reported mortality rate higher than 50% in ARDS COVID patients requiring intubation and mechanical ventilation. Before being intubated and admitted to ICU, COVID patients require increasing rate of oxygen delivery. From the start of the epidemics, we have observed that an oxygenotherapy rate higher than 3L/min at the initial phase of the disease was associated with a high risk of severe acute respiratory distress (30%)
The investigators hypothesize that prone positioning in patients in spontaneous ventilation (not tubed) from the stage of oxygenotherapy higher than 3L/min (to get an SpO2 of 95% or higher) would prevent respiratory worsening and the need for intubation. Prone positioning is easy to apply in patients in spontaneous ventilation since they can change position by themselves.
Read the detailed description
Patients admitted to the hospital with laboratory-confirmed SARS-CoV-2 infection as determined by PCR and/or CT scan showing typical radiological findings (ground glass abnormalities) and requiring O2 3L/min to get an SpO2 higher or equal to 95%.
Patients will be randomised for their position : a group with prone positioning at least 6 hours a day during hosital stay until oxygen weaning or intubation (interventional group) and a group with no instruction regarding positioning (control group). In the interventional group, patients will be suggested to spend 6 hours or more in prone position and will report themselves the time spent in prone position each day. In the control group, patients won't be given any instruction regarding positioning.
Patients will be clinically assessed as usual : monitoring 4 to 8 times a day in the ward and continuous monitoring in ICU.
The need for admission to ICU, high flow nasal oxygenation, non invasive ventilation or intubation or the occurrence of death will be recorded.
- Being tested
- 1: Prone positioning, 2: No instruction regarding positioning
- Keywords
- ARDS, SARS-Cov-2 infection, Prone position, Oxygenotherapy, Intubation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1: Prone positioningBehavioural
the interventional group will be suggested to spend at least 6 hours a day in prone position
2: No instruction regarding positioningBehavioural
group with no instruction regarding positioning (control group)
| Study group | Role | What they receive |
|---|---|---|
| 1: Prone positioning | Experimental | the interventional group will be suggested to spend at least 6 hours a day in prone position Receives: Behavioral: 1: Prone positioning |
| 2: No instruction regarding positioning | Other | the control group will get no instruction regarding positioning Receives: Behavioral: 2: No instruction regarding positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who meet one or both following criteria: need for intubation (for mechanical ventilation), occurrence of death during hospital stay.
Measured: At day28
Secondary outcomes (5)
Proportion of patients admitted to ICU (for patients included out of ICU)
Measured: At day28
Days alive and free from non invasive ventilation (NIV) or high flow nasal canula oxygen delivery (HFNC) (for those neither under NIV or HFNC at the time of study inclusion)
Measured: At day28
Days alive and out of ICU
Measured: At day28
Days alive and out of hospital
Measured: At day28
Maximum oxygenotherapy rate during hospital stay [Time Frame: At day28]
Measured: At day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start26 Jun 2020
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Masking
- None (open label)
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anatole HARROIS, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366856
- Sponsor's protocol ID
- APHP200504
- Acronym
- PROVID
- Status last verified
- Dec 2021
- First submitted
- 26 Apr 2020
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Harrois A, Jouffroy R, Ayed S, Bruel C, Savale L, Devaux M, Maillet M, Cerf C, Lejealle C, Moreno CG, Levrat A, Gueneau R, Jouveshomme S, Bonnin P, De Rudnicki S, Damoisel C, Gille T, Cordel H, Meslin S, Bocquillon V, Noel N, Vieillard-Baron A, Teboul JL, Tran M, Werner M, Pichon J, Janbain A, Vicaut E, Duranteau J; PROVID Study Group. Awake Prone Positioning in Patients With COVID-19 Respiratory Failure: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2548201. doi: 10.1001/jamanetworkopen.2025.48201.
PubMed 41370078
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROne Positioning in coVID-19 Oxygeno-dependent Patients in Spontaneous Ventilation (PROVID Study)
- ClinicalTrials.gov ID
- NCT04366856
- Acronym / sponsor ID
- PROVID / APHP200504
- Keywords
- ARDS, SARS-Cov-2 infection, Prone position, Oxygenotherapy, Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 29 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 COVID epidemics is responsible for a huge number of death following COVID acute respiratory failure. First instance treatment includes oxygenotherapy up to 15L/min in spontaneous ventilation. However COVID infection can ultimately lead to an acute respiratory distress syndrome (ARDS) requiring mechanical ventilation in the intensive care unit (ICU). Guidelines on ARDS management are based on small ventilation volume (6 mL/kg), a pulmonary end expiratory pressure (PEEP) chosen to get the best pulmonary compliance, a plateau pressure lower than 30 cm of water and daily prone positioning when PaO2/FiO2 ratio is lower than 150. In ventilated ARDS patients, prone positioning has shown survival improvement. Though they applied this optimized management of ARDS patients, Chinese intensivists have recently reported mortality rate higher than 50% in ARDS COVID patients requiring intubation and mechanical ventilation. Before being intubated and admitted to ICU, COVID patients require increasing rate of oxygen delivery. From the start of the epidemics, we have observed that an oxygenotherapy rate higher than 3L/min at the initial phase of the disease was associated with a high risk of severe acute respiratory distress (30%)
The investigators hypothesize that prone positioning in patients in spontaneous ventilation (not tubed) from the stage of oxygenotherapy higher than 3L/min (to get an SpO2 of 95% or higher) would prevent respiratory worsening and the need for intubation. Prone positioning is easy to apply in patients in spontaneous ventilation since they can change position by themselves.
Detailed description
Patients admitted to the hospital with laboratory-confirmed SARS-CoV-2 infection as determined by PCR and/or CT scan showing typical radiological findings (ground glass abnormalities) and requiring O2 3L/min to get an SpO2 higher or equal to 95%.
Patients will be randomised for their position : a group with prone positioning at least 6 hours a day during hosital stay until oxygen weaning or intubation (interventional group) and a group with no instruction regarding positioning (control group). In the interventional group, patients will be suggested to spend 6 hours or more in prone position and will report themselves the time spent in prone position each day. In the control group, patients won't be given any instruction regarding positioning.
Patients will be clinically assessed as usual : monitoring 4 to 8 times a day in the ward and continuous monitoring in ICU.
The need for admission to ICU, high flow nasal oxygenation, non invasive ventilation or intubation or the occurrence of death will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Prone positioning | Experimental | Behavioral: 1: Prone positioningthe interventional group will be suggested to spend at least 6 hours a day in prone position |
| 2: No instruction regarding positioning | Other | Behavioral: 2: No instruction regarding positioningthe control group will get no instruction regarding positioning |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients admitted to the hospital
- Laboratory-confirmed SARS-CoV-2 infection as determined by PCR and/or CT scan showing typical radiological findings (ground glass abnormalities)
- Need for O2 3L/min to get an SpO2 higher or equal to 95%.
- Patient able to understand and to get in prone postion themself
- No therapeutic limitation
Key exclusion criteria (3 listed)
- Age > 80 years
- Pregnancy
- Impossibility to get in prone position
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 |
|---|---|---|
| 1: Prone positioningthe interventional group will be suggested to spend at least 6 hours a day in prone position | Behavioural | 1: Prone positioning |
| 2: No instruction regarding positioninggroup with no instruction regarding positioning (control group) | Behavioural | 2: No instruction regarding positioning |
Primary outcome
Proportion of patients who meet one or both following criteria: need for intubation (for mechanical ventilation), occurrence of death during hospital stay.
Time frame: At day28
5 secondary outcomes
Proportion of patients admitted to ICU (for patients included out of ICU)
Time frame: At day28
Days alive and free from non invasive ventilation (NIV) or high flow nasal canula oxygen delivery (HFNC) (for those neither under NIV or HFNC at the time of study inclusion)
Time frame: At day28
Days alive and out of ICU
Time frame: At day28
Days alive and out of hospital
Time frame: At day28
Maximum oxygenotherapy rate during hospital stay [Time Frame: At day28]
Time frame: At day28
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 13 Dec 2021.
- Derived from this study: PubMed 41370078Harrois A, Jouffroy R, Ayed S, Bruel C, Savale L, Devaux M, Maillet M, Cerf C, Lejealle C, Moreno CG, Levrat A, Gueneau R, Jouveshomme S, Bonnin P, De Rudnicki S, Damoisel C, Gille T, Cordel H, Meslin S, Bocquillon V, Noel N, Vieillard-Baron A, Teboul JL, Tran M, Werner M, Pichon J, Janbain A, Vicaut E, Duranteau J; PROVID Study Group. Awake Prone Positioning in Patients With COVID-19 Respiratory Failure: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2548201. doi: 10.1001/jamanetworkopen.2025.48201.
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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.
Anatole HARROIS principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1: Prone positioning and 2: No instruction regarding positioning in people with COVID and ARDS, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 3 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 13 Dec 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 France. 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?
Proportion of patients who meet one or both following criteria: need for intubation (for mechanical ventilation), occurrence of death during hospital stay. (time frame: At day28). 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 NCT04366856, which also lists 1 linked publication.
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 13 Dec 2021.