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Proning Early in Awake COVID-19 Hypoxic Respiratory Failure (PREACHR) Study (PREACHR)

Primary Purpose

Covid19, Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proning
Supportive Care
Sponsored by
New York Hospital Queens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >18
  • Presenting to the ED with symptoms suggestive of COVID-19
  • Assessed by ED attending physician to not require emergent intubation
  • Normal mental status and ability to communicate symptoms/distress
  • Able to follow instructions independently

Exclusion Criteria:

  • Severe respiratory distress requiring immediate intervention
  • Unable to follow verbal instructions
  • Unable to communicate their needs, symptoms, or distress
  • Inability to tolerate prone positioning due to mental status or habitus

Sites / Locations

  • New York Presbyterian Queens

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Proning

Arm Description

Usual Care

Proning, rotating 90 degrees on long axis every 30 minutes - 2 hours

Outcomes

Primary Outcome Measures

All-cause mortality
All-cause mortality
Need for intubation
Need for intubation

Secondary Outcome Measures

Number of repeat visits for same complaint
Number of repeat visits in 30 days for same complaint

Full Information

First Posted
May 4, 2021
Last Updated
November 21, 2021
Sponsor
New York Hospital Queens
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1. Study Identification

Unique Protocol Identification Number
NCT05130541
Brief Title
Proning Early in Awake COVID-19 Hypoxic Respiratory Failure (PREACHR) Study
Acronym
PREACHR
Official Title
Proning Early in Awake COVID-19 Hypoxic Respiratory Failure (PREACHR) Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Hospital Queens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this proposal is to study whether proning, a technique that has previously been shown to improve lung function in patients with acute respiratory distress syndrome (ARDS), can prevent those with mild to moderate symptoms of COVID-19 from progressing to severe disease when initiated early, thereby averting intubation, reducing hospitalization, and, ultimately, decreasing mortality.
Detailed Description
COVID-19 is a global pandemic caused by the novel coronavirus SARS-COV-2. At this time, SARS-CoV-2 is believed to infect alveolar cells, directly impairing lung function and eliciting a profound inflammatory response that further damages the lungs. Between 1 in 20 and 1 in 10 patients infected with this virus die. A crucial decision point in the treatment of patients with COVID-19 in the Emergency Department is the decision to admit to the hospital for further treatment, or discharge the moderately symptomatic (hypoxic and feel ill) but not critically ill patients. However, patients who present with initially mild to moderate symptoms may progress to severe disease. There is, therefore, an unmet need to identify interventions that prevent progression to critical illness in moderately symptomatic patients. Anecdotal reports from Emergency Physicians suggest that alternating prone and supine positioning (i.e. instructing the patient to periodically turn over) improves hypoxia and delays intubation. Dubbed proning, this technique improves hypoxia in 6-7 out of 10 intubated patients with severe acute respiratory distress syndrome (ARDS). Alternating supine and prone positioning improves the recruitment of alveoli, improves ventilation-perfusion matching, increases end-expiratory lung volumes, and improves pulmonary lymphatic drainage. This proposal is innovative because it studies the extension of an intervention previously restricted to patients in the intensive care units with severe acute respiratory distress syndrome (ARDS). Current literature on proning in awake patients with ARDS is limited to retrospective studies with no randomized controlled trials. Further, no clinical trials to date have explored the benefits of early awake proning in COVID-19. The development of a treatment that prevents disease progression and hospitalization in patients moderately ill with COVID-19 would decrease morbidity and mortality from COVID-19 as well as decrease the utilization of scarce healthcare resources. In addition, this trial would be the first randomized controlled-trial, contributing significantly to the nascent evidence base on treatment for COVID-19.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Non-Blinded
Masking
None (Open Label)
Allocation
Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Usual Care
Arm Title
Proning
Arm Type
Experimental
Arm Description
Proning, rotating 90 degrees on long axis every 30 minutes - 2 hours
Intervention Type
Behavioral
Intervention Name(s)
Proning
Intervention Description
Rotating on long axis 90 degrees every 30 minutes
Intervention Type
Other
Intervention Name(s)
Supportive Care
Intervention Description
Usual Care
Primary Outcome Measure Information:
Title
All-cause mortality
Description
All-cause mortality
Time Frame
Within 30 days of discharge from hospital
Title
Need for intubation
Description
Need for intubation
Time Frame
At any time during first hospitalization for hypoxia from COVID-19 up to 2 months
Secondary Outcome Measure Information:
Title
Number of repeat visits for same complaint
Description
Number of repeat visits in 30 days for same complaint
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >18 Presenting to the ED with symptoms suggestive of COVID-19 Assessed by ED attending physician to not require emergent intubation Normal mental status and ability to communicate symptoms/distress Able to follow instructions independently Exclusion Criteria: Severe respiratory distress requiring immediate intervention Unable to follow verbal instructions Unable to communicate their needs, symptoms, or distress Inability to tolerate prone positioning due to mental status or habitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Shin, MD
Organizational Affiliation
NYP Queens
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Will consider compelling cases if appropriately deidentified and, of course, if reviewers or journal editors request

Learn more about this trial

Proning Early in Awake COVID-19 Hypoxic Respiratory Failure (PREACHR) Study

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