NCT04517123

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable covid19

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 13, 2022

Status Verified

October 1, 2021

Enrollment Period

1.3 years

First QC Date

August 14, 2020

Last Update Submit

January 12, 2022

Conditions

Covid19Pneumonia, Viral

Keywords

covid19pneumoniaprone positioningCOVID

Outcome Measures

Primary Outcomes (1)

  • Occurrence of an escalation in respiratory related care (yes vs no)

    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).

    During hospitalization, up to 30 days

Secondary Outcomes (2)

  • Oxygen Saturation

    Over a consecutive 24-hour period after randomization

  • Respiratory Effort as assessed by Respiratory Rate

    Over a consecutive 24-hour period after randomization

Study Arms (2)

Control - Usual Care

NO INTERVENTION

Usual Care

Intervention - Prone Positioning

EXPERIMENTAL

Prone Positioning

Other: Prone Positioning

Interventions

Prone PositioningOTHER

Prone Positioning

Intervention - Prone Positioning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Johns Hopkins Univeristy

Baltimore, Maryland, 21287, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

COVID-19Pneumonia, ViralPneumonia

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Naresh Punjabi, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2020

First Posted

August 18, 2020

Study Start

September 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 13, 2022

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(4)