COVID-19 Patient Positioning Pragmatic Trial
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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 :
Completed
First Posted : April 24, 2020
Results First Posted : December 27, 2021
Last Update Posted : December 27, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Other: Prone Other: Usual Care | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 501 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 |
Actual Study Completion Date : | January 17, 2021 |

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.
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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.
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Other: Prone
Provider-recommended guidance on prone positioning of patients
Other Name: Proning |
- Number of Participants Categorized on the Modified WHO Ordinal Scale by the Highest Level of Support on Day 5 [ 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
- 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.

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, Illinois | |
NorthShore University HealthSystem | |
Highland Park, Illinois, United States, 60035 | |
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Todd W Rice, MD, MSc | Vanderbilt University Medical Center |
Documents provided by Todd Rice, Vanderbilt University Medical Center:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Results First Posted: | December 27, 2021 |
Last Update Posted: | December 27, 2021 |
Last Verified: | December 2021 |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |