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Completed

NCT Number: NCT05130541

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Presbyterian Queens

Flushing, New York, 11355, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proning

Behavioral

Rotating on long axis 90 degrees every 30 minutes

Supportive Care

Other

Usual Care

Primary outcomes

  1. All-cause mortality

    Time frame: Within 30 days of discharge from hospital

    All-cause mortality

  2. Need for intubation

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

    Need for intubation

Secondary outcomes

  1. Number of repeat visits for same complaint

    Time frame: 30 days

    Number of repeat visits in 30 days for same complaint

Sponsors and collaborators

Lead sponsor

New York Hospital Queens

Other

Registry information

Acronym: PREACHR

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 23, 2021
Registry last updated
Nov 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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