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Prone Position and Respiratory Outcomes in Non-Intubated COVID-19 PatiEnts The "PRONE" Study (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: NCT04517123
Recruitment Status : Recruiting
First Posted : August 18, 2020
Last Update Posted : October 12, 2020
Sponsor:
Collaborators:
Duke University
University of North Carolina
University of Miami
University of Pittsburgh
Smith & Nephew, Inc.
Nox Medical Iceland
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
The overall objective of this study is to determine whether a positional maneuver (e.g., prone positioning) decreases the need for escalation of respiratory-related care in patients with coronavirus (COVID-19) pneumonia.

Condition or disease Intervention/treatment Phase
Covid19 Pneumonia, Viral Other: Prone Positioning Not Applicable

Detailed Description:
As the initial outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the disease it causes, coronavirus disease 2019 (COVID-19) has spread beyond Wuhan, China it has become a pandemic affecting over 178 countries. Of patients admitted to the ICU, upwards of 85% developed the acute respiratory distress syndrome (ARDS) and most if not all required mechanical ventilation. The beneficial effects of prone positioning for ARDS have been well described. Coupling the reported benefits of prone positioning in COVID-19 associated ARDS patients with the known beneficial effects of early prone-positioning in the treatment of ARDS, it is not surprising that many hospital systems are advocating prone positioning for treatment of ARDS in patients with COVID-19. However, as the pandemic continues to progress in the United States and the number of new cases grows as new clusters emerge, the possibility of 'rationing' ventilators becomes more real. Therefore, therapies that prevent the need for mechanical ventilation are desperately needed. Given the distinct benefit that patients with COVID-19 have with prone positioning, the overarching hypothesis of this trial is that patients with high risk for respiratory failure may also benefit from prone positioning.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prone Position and Respiratory Outcomes in Non-Intubated COVID-19 PatiEnts The "PRONE" Study
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
No Intervention: Control - Usual Care
Usual Care
Experimental: Intervention - Prone Positioning
Prone Positioning
Other: Prone Positioning
Prone Positioning




Primary Outcome Measures :
  1. Occurrence of an escalation in respiratory related care (yes vs no) [ Time Frame: During hospitalization, up to 30 days ]

    Participants will be assessed for the occurrence of an escalation in respiratory related care (Yes or No). Escalation in respiratory related care is clinically defined as any of the following:

    1. intubation
    2. any increase in flow of supplemental oxygen
    3. transition to high flow nasal cannula
    4. increase in fraction of inspired oxygen
    5. transfer from a lower to a higher level acuity of care (e.g. medical floor to intermediate care unit (IMC) or intensive care unit (ICU); IMC to ICU).


Secondary Outcome Measures :
  1. Oxygen Saturation [ Time Frame: Over a consecutive 24-hour period after randomization ]
    Oxygen Saturation measured in percent oxygen over a 24-hour period.

  2. Respiratory Effort as assessed by Respiratory Rate [ Time Frame: Over a consecutive 24-hour period after randomization ]
    Respiratory effort will be assessed using the respiratory rate (in breaths per minute) over a 24-hour period.



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.


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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:

  • Age ≥ 18 years
  • COVID-19 positive by nasopharyngeal swab or serostatus
  • Use of supplemental oxygen OR respiratory rate ≥ 20

Exclusion Criteria:

  • BMI ≥ 45 kg/m2
  • Pregnancy
  • Chest tube placement
  • Hemodynamic instability with mean arterial pressure < 60 mmHg
  • Thoracic or abdominal wounds
  • Chest wall deformities
  • Vertebral column deformities that would preclude prone positioning
  • Facial trauma or surgery in the last 30 days
  • Established diagnosis of interstitial lung disease
  • Prior single or double lung transplant
  • Surgery for spine, femur, or pelvis in the last 3 months
  • Thoracic or cardiac surgery in the last 30 days
  • Pacemaker placement last 7 days

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): NCT04517123


Contacts
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Contact: Mahendra Damarla 410-550-0545 mdamarl1@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Univeristy Recruiting
Baltimore, Maryland, United States, 21287
Contact: Mahendra Damarla, MD       mdamarl1@jhmi.edu   
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Jaspn Mock, MD, PhD       jason_mock@med.unc.edu   
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Eugene Friedman, MD, PhD       eugene.friedman@duke.edu   
United States, Pennsylvania
UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: William Bain, MD       bainwg@UPMC.edu   
Contact: Tomeka Suber, MD, PhD       subert12@upmc.edu   
Sponsors and Collaborators
Johns Hopkins University
Duke University
University of North Carolina
University of Miami
University of Pittsburgh
Smith & Nephew, Inc.
Nox Medical Iceland
Investigators
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Principal Investigator: Naresh Punjabi, MD Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04517123    
Other Study ID Numbers: IRB00249663
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 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 Johns Hopkins University:
covid19
pneumonia
prone positioning
COVID
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases