Covid19PREACHRNCT05130541
Proning Early in Awake COVID-19 Hypoxic Respiratory Failure (PREACHR) Study
A study testing Proning and Supportive Care in people with Covid19 and Respiratory Failure, run by New York Hospital Queens at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Respiratory Failure
- What is being tested?
- Proning and Supportive Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Queens
Flushing, New York, 11355
About this 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.
Read the 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.
- Conditions
- Covid19, Respiratory Failure
- Being tested
- Proning, Supportive Care
- Medical subject headings
- COVID-19, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProningBehavioural
Rotating on long axis 90 degrees every 30 minutes
Supportive CareOther
Usual Care
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Usual Care Receives: Other: Supportive Care |
| Proning | Experimental | Proning, rotating 90 degrees on long axis every 30 minutes - 2 hours Receives: Behavioral: Proning; Other: Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause mortality
Measured: Within 30 days of discharge from hospital
Need for intubation
Need for intubation
Measured: 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
Number of repeat visits in 30 days for same complaint
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start1 Jun 2020
- Primary completion1 Mar 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Non-Blinded
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Hospital Queens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Chary, New York Hospital Queens
- Investigators
- Richard Shin, MD, Principal investigator, NYP Queens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130541
- Sponsor's protocol ID
- 12910420
- Acronym
- PREACHR
- Status last verified
- Nov 2021
- First submitted
- 4 May 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will consider compelling cases if appropriately deidentified and, of course, if reviewers or journal editors request
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proning Early in Awake COVID-19 Hypoxic Respiratory Failure (PREACHR) Study
- ClinicalTrials.gov ID
- NCT05130541
- Acronym / sponsor ID
- PREACHR / 12910420
- Conditions
- Covid19, Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- New York Hospital QueensUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Non-Blinded
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Supportive CareUsual Care |
| Proning | Experimental | Behavioral: Proning, Other: Supportive CareProning, rotating 90 degrees on long axis every 30 minutes - 2 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProningRotating on long axis 90 degrees every 30 minutes | Behavioural | Proning |
| Supportive CareUsual Care | Other | Control, Proning |
Primary outcome
All-cause mortality
Time frame: Within 30 days of discharge from hospital
All-cause mortality
Need for intubation
Time frame: At any time during first hospitalization for hypoxia from COVID-19 up to 2 months
Need for intubation
1 secondary outcome
Number of repeat visits for same complaint
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Individual participant dataSharing planned: Yes. Will consider compelling cases if appropriately deidentified and, of course, if reviewers or journal editors request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Shin, MD principal investigator
NYP Queens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proning and Supportive Care in people with Covid19 and Respiratory Failure, run by New York Hospital Queens at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: Within 30 days of discharge from hospital). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.