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

March 21, 2021 updated by: Ivan Pavlov, Hôpital de Verdun

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Gaspé, Quebec, Canada, G4X 2W2
        • Hôtel-Dieu de Gaspé
      • Laval, Quebec, Canada, H7M 3L9
        • Hopital de la Cite-de-la-Sante
      • Montréal, Quebec, Canada, H4G2A2
        • Hôpital de Verdun
      • Montréal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital, McGill University Healthcare Center
      • Montréal, Quebec, Canada, H4A 3J1
        • Royal Victoria Hospital, McGill University Healthcare Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death
Time Frame: Up to 28 days after randomization
Up to 28 days after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Intubation rate
Time Frame: Up to 28 days after randomization
Up to 28 days after randomization
Mortality
Time Frame: Up to 28 days after randomization
Up to 28 days after randomization
Days spent on mechanical ventilation
Time Frame: Until discharge, up to 24 weeks after randomization
Until discharge, up to 24 weeks after randomization
Days spent in the ICU
Time Frame: Until discharge, up to 24 weeks after randomization
Until discharge, up to 24 weeks after randomization
Hospital stay (in days)
Time Frame: From admission to discharge, up to 24 weeks after randomization
From admission to discharge, up to 24 weeks after randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 28 days post randomization
Oxygenation (SpO2/FiO2 ratio)
Time Frame: Until HFNC weaning, or up to 14 days after randomization, whichever is first
Daily evolution of oxygenation
Until HFNC weaning, or up to 14 days after randomization, whichever is first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital de Verdun

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2020

Primary Completion (ACTUAL)

March 15, 2021

Study Completion (ACTUAL)

March 15, 2021

Study Registration Dates

First Submitted

May 15, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (ACTUAL)

May 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 21, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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