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Awake Prone Position for Early Hypoxemia in COVID-19 (APPEX-19)

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.
 
ClinicalTrials.gov Identifier: NCT04344587
Recruitment Status : Enrolling by invitation
First Posted : April 14, 2020
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Boston University

Brief Summary:

Prone positioning is a well studied and validated treatment for severe acute respiratory distress syndrome (ARDS), however there are no randomized studies on the use of prone positioning in the non-intubated patient. It is unknown if this intervention would be helpful in preventing further respiratory deterioration in terms of increasing supplemental oxygen requirements, endotracheal intubation, and ICU admission.

The Awake Prone Position for Early hypoxemia in COVID-19 (APPEX-19) Study is a pragmatic adaptive randomized controlled unblinded trial. APPEX-19 randomizes non-ICU patients with COVID-19 or who are under evaluation for COVID-19 to lie in a prone position (i.e, with their stomach and chest facing down) or to usual care.


Condition or disease Intervention/treatment Phase
COVID-19 Other: Self-prone position recommendation Other: Usual care Not Applicable

Detailed Description:

The purpose of this multi-site trial is to investigate the use of prone positioning in SARS-CoV-2 infected patients who are not intubated. The APPEX-19 study is a pragmatic adaptive randomized controlled unblinded trial. The study compares a smartphone tool that recommends non-ICU patients with COVID-19 or who are under evaluation for COVID-19 to lie in a prone position (i.e, with their stomach and chest facing down) to usual care.

Participants who are assigned to the intervention arm will receive a text message containing a link to an online website that reviews how to safely self-prone position and a recommendation to self-prone position 4 times for 1-2 hours each during the day and at night every 24 hours. Participants will also receive twice daily reminders to self-prone using the same smartphone platform.

All participants will receive twice daily Qualtrics online surveys to answer questions about which body positions they used in bed and their level of comfort and shortness of breath. Participants will receive these twice daily text messages until they are discharged, until they are transferred to the ICU, until they die, until their lung function declines, or until 14 days pass since enrollment. Thus, most participants will receive twice daily text messages for about 1 week; it is expected that almost all patients will receive twice daily text messages for no longer than 14 days. Medical charts will be reviewed daily to track routine clinical data to determine outcomes.

Boston Medical Center (BMC) / Boston University will be one of the 16 sites and the data coordinating center for this multisite trial. The unique design of the study means that if evidence accumulates that one treatment is better than the other, more participants will be chosen to receive the prone position intervention that works over time. Thus, the trial will both show what works, implement what works, and make sure that the most participants receive the treatment that works.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Awake Prone Position for Early Hypoxemia in COVID-19
Actual Study Start Date : April 23, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Intervention group
Participants in the intervention arm will receive a text message on their smartphones linking to the Qualtrics intervention website
Other: Self-prone position recommendation

The Qualtrics self-prone position recommendation intervention website will include the following sections:

  1. Welcome message
  2. Educational review of the potential benefits of prone positioning
  3. How-To guide to safely "prone" in a hospital bed
  4. A recommendation to "prone" while lying in bed (4 times for 1-2 hours each during the day and at night every 24 hours).
  5. A reminder to keep track of the time spent in 1) prone position, 2) lying flat on back, 3) lying on side, 4) sitting up, and 5) standing or walking

Active Comparator: Usual care group
Participants in the usual care arm will receive a text message on their smartphone linking to the Qualtrics usual care website
Other: Usual care

The Qualtrics usual care website will include the following sections:

  1. Welcome message
  2. A reminder to keep track of the time spent in 1) prone position, 2) lying flat on back, 3) lying on side, 4) sitting up, and 5) standing or walking




Primary Outcome Measures :
  1. Change in respiratory status [ Time Frame: up to 30 days ]
    Change in respiratory status will be defined as:1) admission to the ICU and/or a 2) an increase in supplemental oxygen delivery (defined as an increase in oxygen delivery rate of ≥2 liter per minute compared to the oxygen delivery rate at the time of intervention or usual care text message that is sustained for ≥12 or more hours OR the switch to an oxygen delivery method that increases the level of supplemental oxygen.


Secondary Outcome Measures :
  1. Length of time participant spends in the prone position [ Time Frame: up to 30 days ]
    Length of time in the prone position will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.

  2. Length of time participant spends in the supine position [ Time Frame: up to 30 days ]
    Length of time in the supine/lying on back position will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.

  3. Length of time participant spends lying on side [ Time Frame: up to 30 days ]
    Length of time lying on side will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.

  4. Length of time participant spends sitting up [ Time Frame: up to 30 days ]
    Length of time sitting up will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.

  5. Length of time participant spends standing or walking [ Time Frame: up to 30 days ]
    Length of time standing or walking will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.

  6. Dyspnea or difficult/labored breathing [ Time Frame: up to 30 days ]
    Dyspnea will be assessed by the modified Borg Dyspnea Score (10-point ordinal scale) from 1= nothing at all to 10= maximal. Higher scores indicate more dyspnea.

  7. Discomfort with proning [ Time Frame: up to 30 days ]
    Discomfort with proning (4-point ordinal scale: very comfortable, somewhat comfortable, somewhat uncomfortable, very uncomfortable)

  8. Length of hospital stay [ Time Frame: up to 30 days ]
    Total number of days hospitalized will be abstracted from the electronic medical record.

  9. Invasive mechanical ventilation [ Time Frame: up to 30 days ]
    Invasive mechanical ventilation will be abstracted from the electronic medical record.

  10. Loss of IV access as a consequence of turning in bed [ Time Frame: up to 30 days ]
    Loss of IV access as a consequence of turning in bed will be reported by participant using monitoring surveys

  11. Acute respiratory distress syndrome (ARDS) diagnosis [ Time Frame: up to 30 days ]
    ARDS diagnosis will be abstracted from the electronic medical record

  12. Hospital mortality [ Time Frame: up to 30 days ]
    Hospital mortality will be abstracted from the electronic medical record



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:

  • Assigned to or admitted to a COVID-19 ward team at a participating site (these teams only admit patients who are under investigation for COVID-19 or who have confirmed COVID-19 infection) via the emergency department (ED) within the last 24 hours
  • Have access to their own functioning smartphone in the hospital room
  • English or Spanish-speaking
  • Ability to read simple instructions and answer simple written questions

Exclusion Criteria:

Baseline patient factors

  • Inability to operate the hospital bed
  • Inability to lie flat comfortably
  • Inability to lie flat without shortness of breath
  • Inability to turn over independently

Medical comorbidities

  • Hemoptysis in the last 2 days
  • Prior lung transplant
  • Dementia

Acute issues

  • Deep venous thrombosis treated for less than 2 days
  • Unstable spine, femur, or pelvic fractures
  • Mean arterial pressure lower than 65 mmHg

Recent interventions

  • Chest tube in place
  • Tracheal surgery or sternotomy during the previous 15 days
  • Serious facial trauma or facial surgery during the previous 15 days
  • Cardiac pacemaker inserted in the last 2 days

Other

  • Pregnancy
  • Comfort measures only status
  • Prisoner

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): NCT04344587


Locations
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United States, California
Alvarado Hospital
San Diego, California, United States, 92120
United States, Colorado
St. Joseph's Hospital National Jewish Health
Denver, Colorado, United States, 80218
United States, District of Columbia
MedStar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
United States, Georgia
Piedmont Atlanta
Atlanta, Georgia, United States, 30309
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68178
United States, Texas
Michael E. DeBakey Veteran Affairs Medical Center
Houston, Texas, United States, 77030
United States, Virginia
VCU Medical Center
Richmond, Virginia, United States, 23219
Spain
Hospital Universitario La Paz
Madrid, Spain, 28049
Sponsors and Collaborators
Boston University
Investigators
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Study Director: Allan J Walkey, MD Boston University
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Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT04344587    
Other Study ID Numbers: H-40070
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 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 Boston University:
Prone position
Coronavirus
Inhalation oxygen therapy
Pragmatic Clinical Tria
Hypoxia
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory