Coronavirus InfectionCOVAYDENCT04395144
COVid-19: Awake Proning and High-flow Nasal Cannula in respiratorY DistrEss
A study testing Awake Prone Positioning in people with Coronavirus Infection and COVID, run by Hôpital de Verdun at 5 sites in Canada.
Trial summary
Prone positioning is an established intervention in mechanically ventilated acute respiratory distress syndrome (ARDS) patients, with demonstrated reductions in mortality. Preliminary data suggest that awake proning in patients with COVID-19 treated with high-flow nasal oxygenation (HFNO) improves gas exchanges, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infection, COVID, Severe Acute Respiratory Syndrome
- What is being tested?
- Awake Prone Positioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 5 sitesCanada
- Study dates
- 15 May 2020to 15 Mar 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
- COVID-19, either confirmed by SARS-CoV-2 assay, or clinically suspected, with results of the assay pending;
- Lung infiltrates documented on chest X-ray or chest CT-scan;
- Significant respiratory distress that requires treatment with HFNO.
Who cannot join
- Unable to consent;
- Unable to prone;
- Indication for immediate endotracheal intubation and mechanical ventilation;
- Contraindication to prone positioning (severe obesity, abdominal wound, pregnancy, unstable pelvic/spinal lesions, vomiting, etc.);
- Comfort care or imminent expectation of death.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Hôtel-Dieu de Gaspé
Gaspé, Quebec, G4X 2W2
Hôpital de la Cité-de-la-Santé
Laval, Quebec, H7M 3L9
Montreal General Hospital, McGill University Healthcare Center
Montreal, Quebec, H3G 1A4
Royal Victoria Hospital, McGill University Healthcare Center
Montreal, Quebec, H4A 3J1
Hôpital de Verdun
Montreal, Quebec, H4G2A2
About this study
Official title: Randomized-controlled Trial of HFNC Alone vs HFNC and Awake Self-proning for Treatment of Severe COVID-19
Prone positioning is an established intervention in mechanically ventilated acute respiratory distress syndrome (ARDS) patients, with demonstrated reductions in mortality.
Preliminary data suggest that awake proning in patients with COVID-19 treated with high-flow nasal oxygenation (HFNO) improves gas exchanges, and might be associated with a reduced need of mechanical ventilation, and reduced mortality. Further investigation in a formal randomized-controlled trial is need.
- Conditions
- Coronavirus Infection, COVID, Severe Acute Respiratory Syndrome, Respiratory Failure, Respiratory Insufficiency, Respiratory Distress Syndrome
- Being tested
- Awake Prone Positioning, Standard care
- Keywords
- SARS-CoV-2, SARS-CoV-2 infection, COVID-19, HFNC, HFNO, Proning, Prone position, High-flow nasal cannula, High-flow nasal oxygenation, Acute Respiratory Distress Syndrome
- Medical subject headings
- Coronavirus Infections, Severe Acute Respiratory Syndrome, Respiratory Insufficiency, Respiratory Distress Syndrome, Lung Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awake Prone PositioningProcedure or surgery
Patients will receive instruction to remain in prone position as long and as often as possible, up to 16h/24h
Standard careProcedure or surgery
Patients will not receive any special instructions with regards to proning.
| Study group | Role | What they receive |
|---|---|---|
| Awake prone positioning | Experimental | Prone positioning of patients on nasal high-flow oxygen therapy Receives: Procedure: Awake Prone Positioning |
| Standard care | Active comparator | Standard decubitus positioning of patients on nasal high-flow oxygen therapy Receives: Procedure: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death
Measured: Up to 28 days after randomization
Secondary outcomes (5)
Intubation rate
Measured: Up to 28 days after randomization
Mortality
Measured: Up to 28 days after randomization
Days spent on mechanical ventilation
Measured: Until discharge, up to 24 weeks after randomization
Days spent in the ICU
Measured: Until discharge, up to 24 weeks after randomization
Hospital stay (in days)
Measured: From admission to discharge, up to 24 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start15 May 2020
- Primary completion15 Mar 2021
- Study completion15 Mar 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 Coronavirus 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
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital de Verdun
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Pavlov, Hôpital de Verdun
- Investigators
- Ivan Pavlov, MD, Principal investigator, Hôpital de Verdun
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395144
- Sponsor's protocol ID
- 2021-01
- Acronym
- COVAYDE
- Status last verified
- Mar 2021
- First submitted
- 15 May 2020
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone Positioning Meta-Trial Group. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med. 2021 Dec;9(12):1387-1395. doi: 10.1016/S2213-2600(21)00356-8. Epub 2021 Aug 20.
PubMed 34425070Tavernier E, McNicholas B, Pavlov I, Roca O, Perez Y, Laffey J, Mirza S, Cosgrave D, Vines D, Frat JP, Ehrmann S, Li J. Awake prone positioning of hypoxaemic patients with COVID-19: protocol for a randomised controlled open-label superiority meta-trial. BMJ Open. 2020 Nov 11;10(11):e041520. doi: 10.1136/bmjopen-2020-041520.
PubMed 33177145
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized-controlled Trial of HFNC Alone vs HFNC and Awake Self-proning for Treatment of Severe COVID-19
- ClinicalTrials.gov ID
- NCT04395144
- Acronym / sponsor ID
- COVAYDE / 2021-01
- Conditions
- Coronavirus Infection, COVID, Severe Acute Respiratory Syndrome, Respiratory Failure, Respiratory Insufficiency, Respiratory Distress Syndrome
- Keywords
- SARS-CoV-2, SARS-CoV-2 infection, COVID-19, HFNC, HFNO, Proning, Prone position, High-flow nasal cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hôpital de VerdunUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 20 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.
Prone positioning is an established intervention in mechanically ventilated acute respiratory distress syndrome (ARDS) patients, with demonstrated reductions in mortality.
Preliminary data suggest that awake proning in patients with COVID-19 treated with high-flow nasal oxygenation (HFNO) improves gas exchanges, and might be associated with a reduced need of mechanical ventilation, and reduced mortality. Further investigation in a formal randomized-controlled trial is need.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Awake prone positioning | Experimental | Procedure: Awake Prone PositioningProne positioning of patients on nasal high-flow oxygen therapy |
| Standard care | Active comparator | Procedure: Standard careStandard decubitus positioning of patients on nasal high-flow oxygen therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COVID-19, either confirmed by SARS-CoV-2 assay, or clinically suspected, with results of the assay pending;
- Lung infiltrates documented on chest X-ray or chest CT-scan;
- Significant respiratory distress that requires treatment with HFNO.
Key exclusion criteria (5 listed)
- Unable to consent;
- Unable to prone;
- Indication for immediate endotracheal intubation and mechanical ventilation;
- Contraindication to prone positioning (severe obesity, abdominal wound, pregnancy, unstable pelvic/spinal lesions, vomiting, etc.);
- Comfort care or imminent expectation of death.
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 Prone PositioningPatients will receive instruction to remain in prone position as long and as often as possible, up to 16h/24h | Procedure or surgery | Awake prone positioning |
| Standard carePatients will not receive any special instructions with regards to proning. | Procedure or surgery | Standard care |
Primary outcome
Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death
Time frame: Up to 28 days after randomization
5 secondary outcomes
Intubation rate
Time frame: Up to 28 days after randomization
Mortality
Time frame: Up to 28 days after randomization
Days spent on mechanical ventilation
Time frame: Until discharge, up to 24 weeks after randomization
Days spent in the ICU
Time frame: Until discharge, up to 24 weeks after randomization
Hospital stay (in days)
Time frame: From admission to discharge, up to 24 weeks after randomization
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 23 Mar 2021.
- Derived from this study: PubMed 34425070Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone Positioning Meta-Trial Group. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med. 2021 Dec;9(12):1387-1395. doi: 10.1016/S2213-2600(21)00356-8. Epub 2021 Aug 20.
- Derived from this study: PubMed 33177145Tavernier E, McNicholas B, Pavlov I, Roca O, Perez Y, Laffey J, Mirza S, Cosgrave D, Vines D, Frat JP, Ehrmann S, Li J. Awake prone positioning of hypoxaemic patients with COVID-19: protocol for a randomised controlled open-label superiority meta-trial. BMJ Open. 2020 Nov 11;10(11):e041520. doi: 10.1136/bmjopen-2020-041520.
- 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.
Ivan Pavlov, MD principal investigator
Hôpital de Verdun
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Awake Prone Positioning in people with Coronavirus Infection and COVID, run by Hôpital de Verdun at 5 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 3 inclusion and 5 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 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death (time frame: Up to 28 days after 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 NCT04395144, 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 23 Mar 2021.