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COVID-19 Patient Positioning Pragmatic Trial

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: NCT04359797
Recruitment Status : Active, not recruiting
First Posted : April 24, 2020
Last Update Posted : December 31, 2020
Sponsor:
Information provided by (Responsible Party):
Todd Rice, Vanderbilt University Medical Center

Study Description
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Brief Summary:
This study aims to determine if provider-recommended guidance on supine (on back) vs. prone (on stomach) positioning of patients testing positive for COVID-19 requiring supplemental oxygen, but not yet mechanically ventilated, improves outcomes in the inpatient setting. This study will be performed as a pragmatic clinical trial.

Condition or disease Intervention/treatment Phase
COVID-19 Other: Prone Other: Usual Care Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 503 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will be performed as a pragmatic controlled clinical trial with parallel group assignment.
Masking: Single (Outcomes Assessor)
Masking Description: Patients and providers will necessarily be unblinded, but outcomes will be analyzed by a blind assessor.
Primary Purpose: Supportive Care
Official Title: Pragmatic Trial Exploring Impact of Patient Positioning in the Management of Patients Infected With COVID-19: Supine vs. Prone
Actual Study Start Date : April 27, 2020
Actual Primary Completion Date : December 17, 2020
Estimated Study Completion Date : June 2021
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Usual Care
Participants randomized to this arm will remain in their natural choice of position, which is anticipated to favor a supine, semi-recumbent position.
 Other: Usual Care
No provider-recommendation, patients will remain in their natural choice of position
Active Comparator: Prone
Participants randomized to this arm will be encouraged to lay in a completely prone position for as much time as is tolerable during hospitalization.
 Other: Prone
Provider-recommended guidance on prone positioning of patients
Other Name: Proning


Outcome Measures
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Primary Outcome Measures :
  1. Modified WHO Ordinal Scale [ Time Frame: 5 days post-randomization ]

    The highest level of support on the 5th day after enrollment according to the following scale adjusted for patient status at enrollment according to the same scale and ranked by mean FIO2 within each category, as appropriate.

    • Death
    • ECMO
    • Mechanical ventilation (ranked by mean FIO2)
    • Non-invasive ventilation such as BiPAP (ranked by mean FIO2)
    • High flow nasal cannula, e.g. Optiflow, Vapotherm or other similar device (titrated by FiO2%) (ranked by mean FIO2)
    • Standard nasal cannula (titrated by L/min up to 15 L/min) or face mask (ranked by mean FIO2)
    • Room air


Secondary Outcome Measures :
  1. FIO2 [ Time Frame: First 5 days post-randomization ]
    For each day, the investigators will record the most intensive oxygen delivery mode and then, for that highest level of oxygen support device, the max FiO2 while exposed to that device.


Eligibility Criteria
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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:

  • This study will enroll all patients admitted to VUMC who test positive for COVID-19 and require supplemental oxygen, but are not yet mechanically ventilated.

Exclusion Criteria:

  • Patients admitted on mechanical ventilation will be excluded from enrollment.
Contacts and Locations
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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): NCT04359797


Locations
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United States, Illinois
NorthShore University HealthSystem
Highland Park, Illinois, United States, 60035
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Todd W Rice, MD, MSc Vanderbilt University Medical Center
More Information
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Publications:
Q&A on coronaviruses (COVID-19) [Internet]. [cited 2020 Mar 24];Available from: https://www.who.int/news-room/q-a-detail/q-a-coronaviruses
Feb 24 SS| NR| CN|, 2020. Study of 72,000 COVID-19 patients finds 2.3% death rate [Internet]. CIDRAP. [cited 2020 Mar 24];Available from: http://www.cidrap.umn.edu/news-perspective/2020/02/study-72000-covid-19-patients-finds-23-death-rate

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Responsible Party: Todd Rice, MD, MSc, Associate Professor, Department of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04359797    
Other Study ID Numbers: 200727
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: December 31, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.
Access Criteria: Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No