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

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ClinicalTrials.gov Identifier: NCT04395144
Recruitment Status : Completed
First Posted : May 20, 2020
Last Update Posted : March 23, 2021
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)
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

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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


Locations
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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
Investigators
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Principal Investigator: Ivan Pavlov, MD 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: March 23, 2021
Last Verified: March 2021
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
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Respiratory Tract Infections
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases