COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prone Positioning for Patients on General Medical Wards With COVID19 (COVID-PRONE)

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: NCT04383613
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
Sunnybrook Health Sciences Centre
Sinai Health System
Toronto General Hospital
University Health Network, Toronto
William Osler Health System
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Brief Summary:
COVID-PRONE is a multicenter, pragmatic, single-blind, 2-arm, parallel, randomized controlled trial seeking to compare the pre-emptive prone positioning (i.e. encouraging patients to adopt a prone position before they require mechanical ventilation) to the control arm of standard care alone. Randomization will be stratified by site.

Condition or disease Intervention/treatment Phase
Covid-19 ARDS Other: Prone positioning Not Applicable

Detailed Description:

COVID-PRONE is a multicenter, pragmatic, single-blind, 2-arm, parallel, randomized controlled trial. The intervention is not a medication or a medical device. Instead, the intervention is instructing patients to lie on their stomach while they are in bed.

Patients will be randomized to receive either standard-of-care or pre-emptive prone positioning while in bed (target > 12 hours per day) plus standard of care. Randomization will be stratified by site. Patients randomized to prone positioning will be instructed to i) lie on their stomach supported by their arms and a pillow at the level of their shoulders and another pillow at the level of the pelvis, ii) immediately thereafter their oxygen saturation will be checked, iii) after a two hour period they can reposition to supine (but should be educated on the use of prone position and encouraged to adopt prone position as often as tolerated while in bed); the 2-hour period will be encouraged four times each day in addition to during sleep overnight.

Since there are limited data on the potential risks and benefits of prone positioning, a feasibility analysis will be performed after 30 patients are randomized to identify the rate of serious adverse events in the prone group (e.g., rate of pneumonia, death, intubation) and to understand the change in oxygenation as a result of prone positioning.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is a multicenter, pragmatic, single-blind, 2-arm, parallel, randomized controlled trial.
Masking: Single (Investigator)
Masking Description: The study will be blinded at the level of the statistician.
Primary Purpose: Other
Official Title: Prone Positioning for Patients on General Medical Wards With COVID19: A Multicenter Pragmatic Randomized Trial [COVID-PRONE]
Actual Study Start Date : May 15, 2020
Estimated Primary Completion Date : December 11, 2020
Estimated Study Completion Date : December 11, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PRONE POSITIONING
Patients in this arm will be instructed to lie on their stomach while they are in bed for 7 days or until the first of study hospital discharge or not requiring supplemental oxygen for >24 hours or study outcome.
Other: Prone positioning
The intervention is prone positioning (i.e., instructing a patient to lie on their stomach while they are in bed) for 7 days or until the first of study hospital discharge or not requiring supplemental oxygen for >24 hours or study outcome.

No Intervention: STANDARD OF CARE
Patients in this arm are not specifically instructed to lie on their stomach while they are in bed.



Primary Outcome Measures :
  1. Composite outcome of in-hospital all-cause mortality, invasive or non-invasive mechanical ventilation, or need for FiO2 of 60% or more [ Time Frame: From date of randomization until the date of in-hospital all-cause mortality, invasive or non-invasive mechanical ventilation, need for FiO2 of 60% or more, or date of hospital discharge, whichever came first, assessed up to 4 weeks ]

Secondary Outcome Measures :
  1. Length of hospitalization [ Time Frame: Up to 4 weeks [or until hospital discharge] ]
  2. Adverse events of prone positioning (i.e., venous thromboembolism, pneumonia) [ Time Frame: Up to 7 days [or until hospital discharge] ]
  3. In-hospital all-cause mortality [ Time Frame: From date of randomization until the date of in-hospital all-cause mortality or date of hospital discharge, whichever came first, assessed up to 4 weeks ]
  4. Invasive or non-invasive mechanical ventilation [ Time Frame: From date of randomization until the date of invasive or non-invasive mechanical ventilation, or date of hospital discharge, whichever came first, assessed up to 4 weeks ]
  5. Need for FiO2 of 60% or more [ Time Frame: From date of randomization until the date of need for FiO2 of 60% or more, or date of hospital discharge, whichever came first, assessed up to 4 weeks ]
  6. Ventilator-free days (i.e., the number of days in hospital the patient was not on a ventilator) [ Time Frame: Up to 8 weeks ]
  7. Composite outcome of in-hospital all-cause mortality, invasive or non-invasive mechanical ventilation, or need for FiO2 of 60% or more assessed at 30 days, 90 days and 1 year [ Time Frame: 30 days, 90 days and 1 year after randomization ]
  8. Time spent in prone positioning among patients achieving the composite outcome of in-hospital all-cause mortality, invasive or non-invasive mechanical ventilation, or need for FiO2 of 60% or more [ Time Frame: Up to 7 days ]

Other Outcome Measures:
  1. Feasibility outcome: Change in oxygen saturation before and after prone positioning (to be measured for 72 hours beginning at the time of randomization), which will be calculated as: [ Time Frame: 72 hours ]
    I) The ratio between the patient's oxygen saturation and the amount of oxygen they're inspiring, II) Sustained (i.e., more than 5 minutes) drop in oxygen saturation less than 88% in the prone position on the same oxygen therapy required to maintain a saturation of >92% in the supine position.

  2. Feasibility outcome: Rate or serious adverse events [ Time Frame: Up to 7 days ]
    Rate of serious adverse events as identified through routine care by the patient's attending physician (e.g., venous thromboembolism, pneumonia) or through objective testing (i.e., death, transfer to the intensive care unit). Notably, bacterial pneumonia will be pragmatically defined through the combination of a chest x-ray report identifying evidence of pneumonia and the receipt of antibiotics known to treat pneumonia

  3. Feasibility outcome: Adherence to prone positioning [ Time Frame: Day 3 and day 7 ]
    The patients will be called on day 3 and 7. The research assistant/coordinator will ask the patient to estimate the number of hours spent in prone position.



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
Criteria

Inclusion Criteria:

  1. Patients ≥ 18 years of age
  2. COVID-19 infection is suspected by the treating clinician or confirmed by diagnostic test
  3. Able to lie on their stomach with verbal instruction
  4. Requiring supplemental oxygen less than or equal to 50% FiO2
  5. Capable to make treatment related decisions
  6. Hospitalized in the last 48 hours with suspected or confirmed COVID-19 infection or diagnosed for nosocomial infection in the last 48 hours during their hospital stay

Exclusion Criteria:

  1. Inability to follow commands (e.g., delirium, dementia)
  2. indication for mechanical ventilation (e.g., reduced level of consciousness, rapid clinical deterioration)
  3. contraindication to prone positioning (spinal cord injury, unstable c-spine, pelvic fracture, unstable airway, open chest or abdomen, anterior chest tube, recent abdominal surgery in past 14 days)
  4. patients on home CPAP (continue positive airway pressure)
  5. transfer from ICU in past 72 hours
  6. need for telemetry at the time of randomization
  7. pregnant (i.e., more than 20 weeks)
  8. body mass index above 40 kg/m2 (based on clinician's assessment)
  9. Recently completed or plan for intrathoracic or intra-abdominal surgical procedure
  10. severe hemoptysis
  11. pace-maker inserted in past 48 hours

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): NCT04383613


Contacts
Layout table for location contacts
Contact: Fahad Razak, MD, MSc 416-864-6060 ext 77430 fahad.razak@unityhealth.to
Contact: Amol Verma, MD, MPhil 4168646060 ext 76930 amol.verma@unityhealth.to

Locations
Layout table for location information
Canada, Ontario
William Osler Health System Recruiting
Brampton, Ontario, Canada
William Osler Health System Recruiting
Etobicoke, Ontario, Canada
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Fahad Razak, MD, MSc    416-864-6060 ext 77430    fahad.razak@unityhealth.to   
Sinai Health System Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Michael Fralick, MD, PhD       mike.fralick@mail.utoronto.ca   
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
St. Joseph's Health Centre Recruiting
Toronto, Ontario, Canada
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Sunnybrook Health Sciences Centre
Sinai Health System
Toronto General Hospital
University Health Network, Toronto
William Osler Health System
Investigators
Layout table for investigator information
Principal Investigator: Michael Fralick, MD, PhD Sinai Health System
Principal Investigator: Fahad Razak, MD, MSc St. Michael's Hospital (Unity Health Toronto)
Principal Investigator: Amol Verma, MD, MPhil St. Michael's Hospital (Unity Health Toronto)
Layout table for additonal information
Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT04383613    
Other Study ID Numbers: 2020-1
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
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