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

NCT05130541 | Completed DMC

• 1 other identifier: 12910420
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Respiratory Failure

Outcome Measures

Primary Outcomes (2)

• All-cause mortality

  All-cause mortality

  Within 30 days of discharge from hospital

• Need for intubation

  Need for intubation

  At any time during first hospitalization for hypoxia from COVID-19 up to 2 months

Secondary Outcomes (1)

• Number of repeat visits for same complaint

  30 days

Study Arms (2)

Control

PLACEBO COMPARATOR

Usual Care

Other: Supportive Care

Proning

EXPERIMENTAL

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

Behavioral: Proning; Other: Supportive Care

Interventions

Proning BEHAVIORAL

Rotating on long axis 90 degrees every 30 minutes

Proning

Supportive Care OTHER

Usual Care

Control; Proning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York Hospital Queens: lead

Study Sites (1)

New York Presbyterian Queens

Flushing, New York, 11355, United States

Location

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Richard Shin, MD

  NYP Queens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Model Details: Randomized Controlled Non-Blinded

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: November 23, 2021
• Study Start: June 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: May 1, 2021
• Last Updated: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

US (1)