Corona Virus InfectionCOVI-PRONENCT04350723
Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 COVID-19 (COVI-PRONE)
A study testing Awake Proning in people with Corona Virus Infection and Covid19, run by St. Joseph's Healthcare Hamilton at 17 sites in 4 countries.
Trial summary
The aim of the COVI-PRONE Trial is to determine if early awake prone positioning in COVID-19 patients with hypoxemic respiratory failure; irrespective of the mode of oxygen delivery; reduces the need for invasive mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corona Virus Infection, Covid19, COVID-19
- What is being tested?
- Awake Proning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 17 sitesin 4 countries
- Study dates
- 10 Jun 2020to 17 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years of age.
- Suspected or confirmed COVID-19. Defined as: a positive PCR for SARS CoV-2 or pending PCR results for patients that are suspected to have COVID-19.
- Hypoxemia on room air (SPO2<90%), and oxygen requirement ≥ 0.4 FiO2 (i.e. ≥ 40% oxygen).
- Bilateral or unilateral chest infiltrates on x-ray as interpreted by the treating team.
- Admitted to the ICU or an acute care bed where hemodynamic and respiratory monitoring is feasible.
Who cannot join
- Immediate need for intubation as determined by the treating team.
- Decreased level of consciousness (Glasgow Coma Scale score <10), or significant cognitive impairment hat may interfere with compliance (delirium, dementia)
- Contraindication to proning including, but not limited to any of the following:
- Open chest or abdomen, abdominal surgery (i.e. laparotomy) within the 4 days, Unstable spine, facial, cervical, femur, or pelvic fractures. Limited neck mobility or inability to lie prone comfortably Skeletal deformities that interfere with proning. Complete bowel obstruction. Active upper gastrointestinal bleeding. Patient is unlikely/unable to prone, or to be compliant as indicated by the treating team.
- Body mass index > 40 kg/m2
- Pregnancy - third trimester.
Show all 11Show fewer
- Patient/substitute decision maker or caring physician's refusal to enroll in the study.
- Patients with hemodynamic instability and moderate to high dose of vasopressors (norepinephrine dose ≥ 0.15 mcg/kg/min)
- Intubation is not within patient's goals of care
- Patient received awake proning session for > 1 day prior to randomization
- Previous intubation within the same hospital admission
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
Canada8 sites
Univeristy of Calgary
Calgary, Alberta
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Hamilton General Hospital
Hamilton, Ontario
Juravinski Hospital
Hamilton, Ontario
CHU de Québec - Université Laval
Québec
St. Catharine's General -
St. Catharines, Ontario
Sinai Health System
Toronto, Ontario
University Health Network - Toronto General Hospital
Toronto, Ontario
Saudi Arabia6 sites
Prince Mohammed bin Abdulaziz Hospital
Al Madīnah
King Abdulaziz Hospital - NGHA
AlAhsa
King Abdulaziz Medical City - Jeddah
Jeddah
King Fahad Hospital of the University
Khobar, Eastern Province
King Abdulaziz Medical City
Riyadh
King Faisal Specialist Hospital & Research Center
Riyadh
United States1 site
University of Texas Health Sciences Centre
Dallas, Texas, 77030
About this study
Official title: Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 (COVI-PRONE): A Randomized Clinical Trial
The aim of the COVI-PRONE Trial is to determine if early awake prone positioning in COVID-19 patients with hypoxemic respiratory failure; irrespective of the mode of oxygen delivery; reduces the need for invasive mechanical ventilation.
- Conditions
- Corona Virus Infection, Covid19, COVID-19
- Being tested
- Awake Proning
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awake ProningProcedure or surgery
The duration of proning will be a total of 8-10 hours with 1-2 hours break in supine position.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Awake Proning | Experimental | The oxygen mask or NIPPV or HFNC will be initiated at the treating team's discretion. The patient will be observed for 15 minutes to ensure that: SPO2 > 90% and the patient is tolerating oxygen mask or NIPPV or HFNC treatment.
Once the patient achieves the above parameters within 15 minutes of initiating oxygen therapy through any modality, the healthcare team will start awake proning. Receives: Procedure: Awake Proning |
| Control - Standard of Care | No intervention | The patient will receive usual care without proning at the discretion of the treating team. The oxygen mask or NIPPV or HFNC will be initiated, the choice of starting oxygen mask versus NIPPV versus HFNC will be up to the treating team, the patient will be observed for 15 minutes to ensure that: SPO2 > 90% and the patient is tolerating NIPPV or HFNC treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotracheal intubation
Medical procedure in which a tube is placed into the windpipe (trachea) through the mouth.
Measured: within 30 days of randomization
Secondary outcomes (6)
Mortality
Death
Measured: 60 days
Invasive mechanical ventilation free days
Number of days not receiving mechanical ventilation
Measured: censored at 30 Days
Non-invasive ventilation free days
Number of days not receiving non-invasive mechanical ventilation
Measured: censored 30 days
Days alive and outside ICU
Number of days alive and outside the ICU
Measured: 60 Days
Days alive and outside of hospital
Number of days alive and outside of hospital
Measured: 60 days
Complications from proning,
Includes any of the following: accidental removal of intravenous access, hypotension, pressure injuries, or other.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start10 Jun 2020
- Primary completion17 Jul 2021
- Study completion17 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Corona Virus InfectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, parallel-group randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- King Abdullah International Medical Research Center, McMaster University, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Waleed Al-Hazzani, St. Joseph's Healthcare Hamilton
- Investigators
- Waleed Alhazzani, Principal investigator, St. Joseph's Healthcare HamiltonYaseen Arabi, Principal investigator, King Saud Bin Abdulaziz University for Health SciencesZainab Alduhailib, Principal investigator, King Faisal Specialist Hospital and Research Center, Jeddah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350723
- Sponsor's protocol ID
- 2154
- Acronym
- COVI-PRONE
- Status last verified
- Oct 2021
- First submitted
- 14 Apr 2020
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alhazzani W, Parhar KKS, Weatherald J, Al Duhailib Z, Alshahrani M, Al-Fares A, Buabbas S, Cherian SV, Munshi L, Fan E, Al-Hameed F, Chalabi J, Rahmatullah AA, Duan E, Tsang JLY, Lewis K, Lauzier F, Centofanti J, Rochwerg B, Culgin S, Nelson K, Abdukahil SA, Fiest KM, Stelfox HT, Tlayjeh H, Meade MO, Perri D, Solverson K, Niven DJ, Lim R, Moller MH, Belley-Cote E, Thabane L, Tamim H, Cook DJ, Arabi YM; COVI-PRONE Trial Investigators and the Saudi Critical Care Trials Group. Effect of Awake Prone Positioning on Endotracheal Intubation in Patients With COVID-19 and Acute Respiratory Failure: A Randomized Clinical Trial. JAMA. 2022 Jun 7;327(21):2104-2113. doi: 10.1001/jama.2022.7993.
PubMed 35569448Alhazzani W, Evans L, Alshamsi F, Moller MH, Ostermann M, Prescott HC, Arabi YM, Loeb M, Ng Gong M, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Machado F, Wunsch H, Crowther M, Cecconi M, Koh Y, Burry L, Chertow DS, Szczeklik W, Belley-Cote E, Greco M, Bala M, Zarychanski R, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Nainan Myatra S, Arrington A, Kleinpell R, Citerio G, Lewis K, Bridges E, Memish ZA, Hammond N, Hayden FG, Alshahrani M, Al Duhailib Z, Martin GS, Kaplan LJ, Coopersmith CM, Antonelli M, Rhodes A. Surviving Sepsis Campaign Guidelines on the Management of Adults With Coronavirus Disease 2019 (COVID-19) in the ICU: First Update. Crit Care Med. 2021 Mar 1;49(3):e219-e234. doi: 10.1097/CCM.0000000000004899.
PubMed 33555780
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 (COVI-PRONE): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04350723
- Acronym / sponsor ID
- COVI-PRONE / 2154
- Conditions
- Corona Virus Infection, Covid19, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- King Abdullah International Medical Research Center, McMaster University, Canadian Institutes of Health Research (CIHR)
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 17 Jul 2021 (actual)
- Study completion
- 17 Jul 2021 (actual)
- First posted
- 17 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 aim of the COVI-PRONE Trial is to determine if early awake prone positioning in COVID-19 patients with hypoxemic respiratory failure; irrespective of the mode of oxygen delivery; reduces the need for invasive mechanical ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A multicenter, parallel-group randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention - Awake Proning | Experimental | Procedure: Awake ProningThe oxygen mask or NIPPV or HFNC will be initiated at the treating team's discretion. The patient will be observed for 15 minutes to ensure that: SPO2 > 90% and the patient is tolerating oxygen mask or NIPPV or HFNC treatment. Once the patient achieves the above parameters within 15 minutes of initiating oxygen therapy through any modality, the healthcare team will start awake proning. |
| Control - Standard of Care | No intervention | –The patient will receive usual care without proning at the discretion of the treating team. The oxygen mask or NIPPV or HFNC will be initiated, the choice of starting oxygen mask versus NIPPV versus HFNC will be up to the treating team, the patient will be observed for 15 minutes to ensure that: SPO2 > 90% and the patient is tolerating NIPPV or HFNC treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ≥ 18 years of age.
- Suspected or confirmed COVID-19. Defined as: a positive PCR for SARS CoV-2 or pending PCR results for patients that are suspected to have COVID-19.
- Hypoxemia on room air (SPO2<90%), and oxygen requirement ≥ 0.4 FiO2 (i.e. ≥ 40% oxygen).
- Bilateral or unilateral chest infiltrates on x-ray as interpreted by the treating team.
- Admitted to the ICU or an acute care bed where hemodynamic and respiratory monitoring is feasible.
Key exclusion criteria (11 listed)
- Immediate need for intubation as determined by the treating team.
- Decreased level of consciousness (Glasgow Coma Scale score <10), or significant cognitive impairment hat may interfere with compliance (delirium, dementia)
- Contraindication to proning including, but not limited to any of the following:
- Open chest or abdomen, abdominal surgery (i.e. laparotomy) within the 4 days, Unstable spine, facial, cervical, femur, or pelvic fractures. Limited neck mobility or inability to lie prone comfortably Skeletal deformities that interfere with proning. Complete bowel obstruction. Active upper gastrointestinal bleeding. Patient is unlikely/unable to prone, or to be compliant as indicated by the treating team.
- Body mass index > 40 kg/m2
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 |
|---|---|---|
| Awake ProningThe duration of proning will be a total of 8-10 hours with 1-2 hours break in supine position. | Procedure or surgery | Intervention - Awake Proning |
Primary outcome
Endotracheal intubation
Time frame: within 30 days of randomization
Medical procedure in which a tube is placed into the windpipe (trachea) through the mouth.
6 secondary outcomes
Mortality
Time frame: 60 days
Invasive mechanical ventilation free days
Time frame: censored at 30 Days
Non-invasive ventilation free days
Time frame: censored 30 days
Days alive and outside ICU
Time frame: 60 Days
Days alive and outside of hospital
Time frame: 60 days
Complications from proning,
Time frame: 30 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 15 Oct 2021.
- Derived from this study: PubMed 35569448Alhazzani W, Parhar KKS, Weatherald J, Al Duhailib Z, Alshahrani M, Al-Fares A, Buabbas S, Cherian SV, Munshi L, Fan E, Al-Hameed F, Chalabi J, Rahmatullah AA, Duan E, Tsang JLY, Lewis K, Lauzier F, Centofanti J, Rochwerg B, Culgin S, Nelson K, Abdukahil SA, Fiest KM, Stelfox HT, Tlayjeh H, Meade MO, Perri D, Solverson K, Niven DJ, Lim R, Moller MH, Belley-Cote E, Thabane L, Tamim H, Cook DJ, Arabi YM; COVI-PRONE Trial Investigators and the Saudi Critical Care Trials Group. Effect of Awake Prone Positioning on Endotracheal Intubation in Patients With COVID-19 and Acute Respiratory Failure: A Randomized Clinical Trial. JAMA. 2022 Jun 7;327(21):2104-2113. doi: 10.1001/jama.2022.7993.
- Derived from this study: PubMed 33555780Alhazzani W, Evans L, Alshamsi F, Moller MH, Ostermann M, Prescott HC, Arabi YM, Loeb M, Ng Gong M, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Machado F, Wunsch H, Crowther M, Cecconi M, Koh Y, Burry L, Chertow DS, Szczeklik W, Belley-Cote E, Greco M, Bala M, Zarychanski R, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Nainan Myatra S, Arrington A, Kleinpell R, Citerio G, Lewis K, Bridges E, Memish ZA, Hammond N, Hayden FG, Alshahrani M, Al Duhailib Z, Martin GS, Kaplan LJ, Coopersmith CM, Antonelli M, Rhodes A. Surviving Sepsis Campaign Guidelines on the Management of Adults With Coronavirus Disease 2019 (COVID-19) in the ICU: First Update. Crit Care Med. 2021 Mar 1;49(3):e219-e234. doi: 10.1097/CCM.0000000000004899.
- 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.
Waleed Alhazzani principal investigator
St. Joseph's Healthcare Hamilton
Yaseen Arabi principal investigator
King Saud Bin Abdulaziz University for Health Sciences
Zainab Alduhailib principal investigator
King Faisal Specialist Hospital and Research Center, Jeddah
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Awake Proning in people with Corona Virus Infection and Covid19, run by St. Joseph's Healthcare Hamilton at 17 sites in 4 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 5 inclusion and 11 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 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Canada, Saudi Arabia, Kuwait, United States. 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: within 30 days of randomization). 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 NCT04350723, which also lists 2 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 15 Oct 2021.