Severe Acute Respiratory Syndrome Coronavirus 2CORONANCT04402879
CORONA (COvid pRONe hypoxemiA): Prone Positioning for Hypoxemic COVID-19 Patients With Do-not-intubate Goals
A study testing Prone Positioning (PP) in people with Severe Acute Respiratory Syndrome Coronavirus 2 and COVID-19, run by University of Calgary at 4 sites in Canada.
Trial summary
The purpose of this trial is to determine whether Prone Positioning (PP) improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candidates for mechanical ventilation in the ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19, Acute Respiratory Distress Syndrome
- What is being tested?
- Prone Positioning (PP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 596 participants
- Where
- 4 sitesCanada
- Study dates
- 10 Nov 2020to 1 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients with probable COVID-19. Probable is defined as Influenza like illness (ILI) symptoms OR confirmed COVID-19 exposure AND COVID-19 testing performed. ILI is defined as any one of the following symptoms including: fever, new or worsening cough, coryza, new or worsening dyspnea, or sore throat.
- Goals of care are do-not-intubate (R3 or M1/M2 in Alberta).
- Need for oxygen ≥2 L to maintain SpO2 ≥92%. If the patient is on long-term oxygen, the O2 requirements must be ≥2 L above their baseline.
- Patient can be positioned to and from prone to supine with minimal assistance (maximum one person assistance).
Who cannot join
- Decreased level of consciousness (Glasgow Coma Scale < 10) or precluding ability to self-reposition.
- Hemodynamic instability (Systolic Blood Pressure < 90 mmHg and or Lactate >5 mmol/L or HR >120, not responsive to fluid resuscitation).
- Complete bowel obstruction.
- Active upper gastrointestinal bleeding.
- Poor neck mobility or patient inability to lie prone comfortably.
- Unstable spine, femur, or pelvic fractures.
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- Pregnancy - third trimester.
- Full resuscitation status including ICU and willingness to accept invasive mechanical ventilation (i.e. R1/R2 goals of care).
- Imminent palliation or end of life expected on admission (i.e. C1/C2 goals of care).
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Peter Lougheed Centre (PLC)
Calgary, Alberta, T1Y 6J4
Foothills Hospital Intensive Care Unit
Calgary, Alberta, T2N 2T9
Rockyview General Hospital
Calgary, Alberta, T2V 1P9
South Health Campus
Calgary, Alberta, T3M 1M4
About this study
Official title: A Prospective Randomized Trial of Prone Positioning Versus Usual Care for Patients With Do-not-intubate Goals of Care and Hypoxemic Respiratory Failure During the Coronavirus SARS-CoV-2 (COVID-19) Pandemic
The purpose of this trial is to determine whether Prone Positioning (PP) improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candidates for mechanical ventilation in the ICU. The investigators hypothesize that PP will reduce in-hospital mortality or discharge to hospice, compared with usual care for non-intubated patients with do-not-intubate goals of care with hypoxemic respiratory failure due to probable COVID-19.
Read the detailed description
As part of the management of COVID-19 related severe ARDS, the World Health Organization (WHO) recommends prone positioned mechanical ventilation. At this time, it is unclear whether there is a role for prone positioning (PP) of non-mechanically ventilated patients.
The objective of this trial is to determine whether PP improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candidates for mechanical ventilation in the ICU. The investigators hypothesize that PP will reduce in-hospital mortality or discharge to hospice, compared with usual care for non-intubated patients with do-not-intubate goals of care with hypoxemic respiratory failure due to probable COVID-19.
Patients randomized to the intervention arm will continue with prone positioning until study inclusion criteria are no longer met, discharge from hospital, day 60 in hospital, or until death or discharge to hospice. Daily assessments will occur until day 60 or until the patient is discharged from hospital or is deceased. The investigators anticipate recruitment to be completed within 12 months of starting the trial.
- Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19, Acute Respiratory Distress Syndrome, ARDS, Hypoxemic Respiratory Failure
- Being tested
- Prone Positioning (PP)
- Keywords
- Prone positioning, non-intubated
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone Positioning (PP)Procedure or surgery
The intervention for this study is PP. Patients at participating sites allocated to the intervention arm of the study will be prompted by ward nurses and respiratory therapists to assume and maintain a prone position for varying durations, four times per day until the occurrence of a primary outcome event or hospital discharge.
The target duration (dose) of PP is > 8 hours per day for up to 60 days, or until oxygen requirements are < 2 L per minute or < 2 L per minute above baseline home oxygen requirements.
| Study group | Role | What they receive |
|---|---|---|
| Prone Positioning (PP) | Experimental | The intervention for this study is PP. Patients at participating sites allocated to the intervention arm of the study will be prompted by ward nurses and respiratory therapists to assume and maintain a prone position for varying durations, four times per day. Receives: Procedure: Prone Positioning (PP) |
| Control - usual management | No intervention | The control group will consist of standard medical care with no instructions or prompts to change positioning to staff or patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality or discharge to hospice
In-hospital mortality or discharge to hospice at Day 60.
Measured: 60 days
Secondary outcomes (9)
Adverse Events and Serious Adverse Events
An Adverse Event (AE) is any unfavourable or other finding (including clinically significant laboratory tests), symptom or disease occurring during the during of the study, whether or not it is considered to be related to the medicinal (investigational) product, not explicitly classified elsewhere in this protocol, and whether or not it is expected. A Serious Adverse Event (AE) is any unfavourable medical finding (including clinically significant laboratory tests) at any dose that:
- Results in death (primary outcome)
- Is life threatening
- Results in persistent of significant disability or incapacity
- Requires in in-patient hospitalisation or prolongation of Hospitalisation
Measured: 60 days
Change in SpO2
Change in SpO2 during each PP session (SpO2 in prone position - SpO2 prior to prone positioning). Clinicians will be asked to record this change for the first proning session per shift (for 12 hour shifts this will result in 2 proning sessions being documented per 24 hour period, and for 8 hour shifts this will result in 3 proning sessions being documented per 24 hour period).
Measured: 60 days
Hospital free days
Number of hospital free days in the 60 days after enrolment.
Measured: 60 days
Admission to ICU
Admission to the Intensive Care Unit.
Measured: 60 days
Intubation and mechanical ventilation
Patient is intubated and requires mechanical ventilation.
Measured: 60 days
Initiation of non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).
Patient requires non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).
Measured: 60 days
Oxygen-free days
The number of oxygen-free days at Day 60 (censored at discharge).
Measured: 60 days
In-hospital death (time)
Time from admission to all-cause in-hospital death.
Measured: 60 days
Death at 90 days
Death at 90 days.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start10 Nov 2020
- Primary completion1 Dec 2021
- Study completion1 Jun 2022
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 Severe Acute Respiratory Syndrome Coronavirus 2Studies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- This is a prospective, unblinded, randomized controlled trial at four (4) medical sites in Calgary, Alberta.
- Masking
- None (open label)
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Principal investigator, Ken Kuljit Parhar, MD, University of Calgary
- Investigators
- Ken Parhar, MD, MSc, Principal investigator, University of CalgaryJason Weatherald, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402879
- Sponsor's protocol ID
- REB20-0518
- Acronym
- CORONA
- Status last verified
- Apr 2026
- First submitted
- 22 May 2020
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Weatherald J, Norrie J, Parhar KKS. Awake prone positioning in COVID-19: is tummy time ready for prime time? Lancet Respir Med. 2021 Dec;9(12):1347-1349. doi: 10.1016/S2213-2600(21)00368-4. Epub 2021 Aug 20. No abstract available.
PubMed 34425072
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Prone Positioning Versus Usual Care for Patients With Do-not-intubate Goals of Care and Hypoxemic Respiratory Failure During the Coronavirus SARS-CoV-2 (COVID-19) Pandemic
- ClinicalTrials.gov ID
- NCT04402879
- Acronym / sponsor ID
- CORONA / REB20-0518
- Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19, Acute Respiratory Distress Syndrome, ARDS, Hypoxemic Respiratory Failure
- Keywords
- Prone positioning, non-intubated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 27 May 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 purpose of this trial is to determine whether Prone Positioning (PP) improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candidates for mechanical ventilation in the ICU. The investigators hypothesize that PP will reduce in-hospital mortality or discharge to hospice, compared with usual care for non-intubated patients with do-not-intubate goals of care with hypoxemic respiratory failure due to probable COVID-19.
Detailed description
As part of the management of COVID-19 related severe ARDS, the World Health Organization (WHO) recommends prone positioned mechanical ventilation. At this time, it is unclear whether there is a role for prone positioning (PP) of non-mechanically ventilated patients.
The objective of this trial is to determine whether PP improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candidates for mechanical ventilation in the ICU. The investigators hypothesize that PP will reduce in-hospital mortality or discharge to hospice, compared with usual care for non-intubated patients with do-not-intubate goals of care with hypoxemic respiratory failure due to probable COVID-19.
Patients randomized to the intervention arm will continue with prone positioning until study inclusion criteria are no longer met, discharge from hospital, day 60 in hospital, or until death or discharge to hospice. Daily assessments will occur until day 60 or until the patient is discharged from hospital or is deceased. The investigators anticipate recruitment to be completed within 12 months of starting the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, unblinded, randomized controlled trial at four (4) medical sites in Calgary, Alberta.
| Arm | Type | Receives |
|---|---|---|
| Prone Positioning (PP) | Experimental | Procedure: Prone Positioning (PP)The intervention for this study is PP. Patients at participating sites allocated to the intervention arm of the study will be prompted by ward nurses and respiratory therapists to assume and maintain a prone position for varying durations, four times per day. |
| Control - usual management | No intervention | –The control group will consist of standard medical care with no instructions or prompts to change positioning to staff or patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized patients with probable COVID-19. Probable is defined as Influenza like illness (ILI) symptoms OR confirmed COVID-19 exposure AND COVID-19 testing performed. ILI is defined as any one of the following symptoms including: fever, new or worsening cough, coryza, new or worsening dyspnea, or sore throat.
- Goals of care are do-not-intubate (R3 or M1/M2 in Alberta).
- Need for oxygen ≥2 L to maintain SpO2 ≥92%. If the patient is on long-term oxygen, the O2 requirements must be ≥2 L above their baseline.
- Patient can be positioned to and from prone to supine with minimal assistance (maximum one person assistance).
Key exclusion criteria (9 listed)
- Decreased level of consciousness (Glasgow Coma Scale < 10) or precluding ability to self-reposition.
- Hemodynamic instability (Systolic Blood Pressure < 90 mmHg and or Lactate >5 mmol/L or HR >120, not responsive to fluid resuscitation).
- Complete bowel obstruction.
- Active upper gastrointestinal bleeding.
- Poor neck mobility or patient inability to lie prone comfortably.
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 Positioning (PP)The intervention for this study is PP. Patients at participating sites allocated to the intervention arm of the study will be prompted by ward nurses and respiratory therapists to assume and maintain a prone position for varying durations, four times per day until the occurrence of a primary outcome event or hospital discharge. The target duration (dose) of PP is > 8 hours per day for up to 60 days, or until oxygen requirements are < 2 L per minute or < 2 L per minute above baseline home oxygen requirements. | Procedure or surgery | Prone Positioning (PP) |
Primary outcome
Hospital mortality or discharge to hospice
Time frame: 60 days
In-hospital mortality or discharge to hospice at Day 60.
9 secondary outcomes
Adverse Events and Serious Adverse Events
Time frame: 60 days
Change in SpO2
Time frame: 60 days
Hospital free days
Time frame: 60 days
Admission to ICU
Time frame: 60 days
Intubation and mechanical ventilation
Time frame: 60 days
Initiation of non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).
Time frame: 60 days
Oxygen-free days
Time frame: 60 days
In-hospital death (time)
Time frame: 60 days
Death at 90 days
Time frame: 90 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 7 May 2026.
- Derived from this study: PubMed 34425072Weatherald J, Norrie J, Parhar KKS. Awake prone positioning in COVID-19: is tummy time ready for prime time? Lancet Respir Med. 2021 Dec;9(12):1347-1349. doi: 10.1016/S2213-2600(21)00368-4. Epub 2021 Aug 20. No abstract available.
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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.
Ken Parhar, MD, MSc principal investigator
University of Calgary
Jason Weatherald, MD principal investigator
University of Calgary
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone Positioning (PP) in people with Severe Acute Respiratory Syndrome Coronavirus 2 and COVID-19, run by University of Calgary at 4 sites in Canada.
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: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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?
Hospital mortality or discharge to hospice (time frame: 60 days). 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 NCT04402879, 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 7 May 2026.