Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

COVid-19: Awake Proning and High-flow Nasal Cannula in respiratorY DistrEss (COVAYDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04395144
Recruitment Status : Completed
First Posted : May 20, 2020
Last Update Posted : March 23, 2021
Information provided by (Responsible Party):
Ivan Pavlov, Hôpital de Verdun

Brief 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 might be associated with a reduced need of mechanical ventilation, and reduced mortality. Further investigation in a formal randomized-controlled trial is need.

Condition or disease Intervention/treatment Phase
Coronavirus Infection COVID Severe Acute Respiratory Syndrome Respiratory Failure Respiratory Insufficiency Respiratory Distress Syndrome ARDS Lung Diseases Procedure: Awake Prone Positioning Procedure: Standard care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized-controlled Trial of HFNC Alone vs HFNC and Awake Self-proning for Treatment of Severe COVID-19
Actual Study Start Date : May 15, 2020
Actual Primary Completion Date : March 15, 2021
Actual Study Completion Date : March 15, 2021

Arm Intervention/treatment
Experimental: Awake prone positioning
Prone positioning of patients on nasal high-flow oxygen therapy
Procedure: Awake Prone Positioning
Patients will receive instruction to remain in prone position as long and as often as possible, up to 16h/24h

Active Comparator: Standard care
Standard decubitus positioning of patients on nasal high-flow oxygen therapy
Procedure: Standard care
Patients will not receive any special instructions with regards to proning.

Primary Outcome Measures :
  1. Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death [ Time Frame: Up to 28 days after randomization ]

Secondary Outcome Measures :
  1. Intubation rate [ Time Frame: Up to 28 days after randomization ]
  2. Mortality [ Time Frame: Up to 28 days after randomization ]
  3. Days spent on mechanical ventilation [ Time Frame: Until discharge, up to 24 weeks after randomization ]
  4. Days spent in the ICU [ Time Frame: Until discharge, up to 24 weeks after randomization ]
  5. Hospital stay (in days) [ Time Frame: From admission to discharge, up to 24 weeks after randomization ]

Other Outcome Measures:
  1. Time in prone position [ Time Frame: Up to 28 days post randomization ]
    Total time spent in prone position, as recorded by nursing or respiratory therapists

  2. Oxygenation (SpO2/FiO2 ratio) [ Time Frame: Until HFNC weaning, or up to 14 days after randomization, whichever is first ]
    Daily evolution of oxygenation

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04395144

Layout table for location information
Canada, Quebec
Hôtel-Dieu de Gaspé
Gaspé, Quebec, Canada, G4X 2W2
Hôpital de la Cité-de-la-Santé
Laval, Quebec, Canada, H7M 3L9
Montreal General Hospital, McGill University Healthcare Center
Montréal, Quebec, Canada, H3G 1A4
Royal Victoria Hospital, McGill University Healthcare Center
Montréal, Quebec, Canada, H4A 3J1
Hôpital de Verdun
Montréal, Quebec, Canada, H4G2A2
Sponsors and Collaborators
Hôpital de Verdun
Layout table for investigator information
Principal Investigator: Ivan Pavlov, MD Hôpital de Verdun
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ivan Pavlov, Emergency physician, Hôpital de Verdun Identifier: NCT04395144    
Other Study ID Numbers: 2021-01
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ivan Pavlov, Hôpital de Verdun:
SARS-CoV-2 infection
Prone position
High-flow nasal cannula
High-flow nasal oxygenation
Acute Respiratory Distress Syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Lung Diseases
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Pathologic Processes
Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases