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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04395144
Recruitment Status : Recruiting
First Posted : May 20, 2020
Last Update Posted : August 11, 2020
Sponsor:
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 346 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
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : December 31, 2020


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

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

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 ClinicalTrials.gov identifier (NCT number): NCT04395144


Contacts
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Contact: Ivan Pavlov, MD 15143621000 ext 63525 ivan.pavlov.md@gmail.com

Locations
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Canada, Quebec
Hôpital de Verdun Recruiting
Montréal, Quebec, Canada, H4G2A2
Contact: Ivan Pavlov, MD    5143621000    ivan.pavlov.md@gmail.com   
Sponsors and Collaborators
Hôpital de Verdun
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ivan Pavlov, Emergency physician, Hôpital de Verdun
ClinicalTrials.gov Identifier: NCT04395144    
Other Study ID Numbers: 2021-01
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
SARS-CoV-2 infection
COVID-19
HFNC
HFNO
Proning
Prone position
High-flow nasal cannula
High-flow nasal oxygenation
Acute Respiratory Distress Syndrome
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Lung Diseases
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Syndrome
Disease
Pathologic Processes
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Infections