Covid19PRONENCT04517123
Prone Position and Respiratory Outcomes in Non-Intubated COVID-19 PatiEnts The "PRONE" Study
A study testing Prone Positioning in people with Covid19 and Pneumonia, Viral, run by Johns Hopkins University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Pneumonia, Viral
- What is being tested?
- Prone Positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Sep 2020to 31 Dec 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 years
- COVID-19 positive by nasopharyngeal swab or serostatus
- Use of supplemental oxygen OR respiratory rate ≥ 20
Who cannot join
- BMI ≥ 45 kg/m2
- Pregnancy
- Chest tube placement
- Hemodynamic instability with mean arterial pressure < 60 mmHg
- Thoracic or abdominal wounds
- Chest wall deformities
Show all 13Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins Univeristy
Baltimore, Maryland, 21287
University of North Carolina
Chapel Hill, North Carolina, 27514
Duke University
Durham, North Carolina, 27710
UPMC
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the detailed description
As the initial outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the disease it causes, coronavirus disease 2019 (COVID-19) has spread beyond Wuhan, China it has become a pandemic affecting over 178 countries. Of patients admitted to the ICU, upwards of 85% developed the acute respiratory distress syndrome (ARDS) and most if not all required mechanical ventilation. The beneficial effects of prone positioning for ARDS have been well described. Coupling the reported benefits of prone positioning in COVID-19 associated ARDS patients with the known beneficial effects of early prone-positioning in the treatment of ARDS, it is not surprising that many hospital systems are advocating prone positioning for treatment of ARDS in patients with COVID-19. However, as the pandemic continues to progress in the United States and the number of new cases grows as new clusters emerge, the possibility of 'rationing' ventilators becomes more real. Therefore, therapies that prevent the need for mechanical ventilation are desperately needed. Given the distinct benefit that patients with COVID-19 have with prone positioning, the overarching hypothesis of this trial is that patients with high risk for respiratory failure may also benefit from prone positioning.
- Conditions
- Covid19, Pneumonia, Viral
- Being tested
- Prone Positioning
- Keywords
- covid19, pneumonia, prone positioning, COVID
- Medical subject headings
- COVID-19, Pneumonia, Viral, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone PositioningOther
Prone Positioning
| Study group | Role | What they receive |
|---|---|---|
| Control - Usual Care | No intervention | Usual Care |
| Intervention - Prone Positioning | Experimental | Prone Positioning Receives: Other: Prone Positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- intubation
- any increase in flow of supplemental oxygen
- transition to high flow nasal cannula
- increase in fraction of inspired oxygen
- 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).
Measured: During hospitalization, up to 30 days
Secondary outcomes (2)
Oxygen Saturation
Oxygen Saturation measured in percent oxygen over a 24-hour period.
Measured: Over a consecutive 24-hour period after randomization
Respiratory Effort as assessed by Respiratory Rate
Respiratory effort will be assessed using the respiratory rate (in breaths per minute) over a 24-hour period.
Measured: Over a consecutive 24-hour period after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start1 Sep 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 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.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, University of North Carolina, University of Miami, University of Pittsburgh, Smith & Nephew, Inc., Nox Medical Iceland
- Responsible party
- Sponsor
- Investigators
- Naresh Punjabi, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517123
- Sponsor's protocol ID
- IRB00249663
- Acronym
- PRONE
- Status last verified
- Oct 2021
- First submitted
- 14 Aug 2020
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Position and Respiratory Outcomes in Non-Intubated COVID-19 PatiEnts The "PRONE" Study
- ClinicalTrials.gov ID
- NCT04517123
- Acronym / sponsor ID
- PRONE / IRB00249663
- Conditions
- Covid19, Pneumonia, Viral
- Keywords
- covid19, pneumonia, prone positioning, COVID
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Duke University, University of North Carolina, University of Miami, University of Pittsburgh, Smith & Nephew, Inc., Nox Medical Iceland
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Aug 2020 (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 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.
Detailed description
As the initial outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the disease it causes, coronavirus disease 2019 (COVID-19) has spread beyond Wuhan, China it has become a pandemic affecting over 178 countries. Of patients admitted to the ICU, upwards of 85% developed the acute respiratory distress syndrome (ARDS) and most if not all required mechanical ventilation. The beneficial effects of prone positioning for ARDS have been well described. Coupling the reported benefits of prone positioning in COVID-19 associated ARDS patients with the known beneficial effects of early prone-positioning in the treatment of ARDS, it is not surprising that many hospital systems are advocating prone positioning for treatment of ARDS in patients with COVID-19. However, as the pandemic continues to progress in the United States and the number of new cases grows as new clusters emerge, the possibility of 'rationing' ventilators becomes more real. Therefore, therapies that prevent the need for mechanical ventilation are desperately needed. Given the distinct benefit that patients with COVID-19 have with prone positioning, the overarching hypothesis of this trial is that patients with high risk for respiratory failure may also benefit from prone positioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control - Usual Care | No intervention | –Usual Care |
| Intervention - Prone Positioning | Experimental | Other: Prone PositioningProne Positioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- COVID-19 positive by nasopharyngeal swab or serostatus
- Use of supplemental oxygen OR respiratory rate ≥ 20
Key exclusion criteria (13 listed)
- BMI ≥ 45 kg/m2
- Pregnancy
- Chest tube placement
- Hemodynamic instability with mean arterial pressure < 60 mmHg
- Thoracic or abdominal wounds
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 |
|---|---|---|
| Prone PositioningProne Positioning | Other | Intervention - Prone Positioning |
Primary outcome
Occurrence of an escalation in respiratory related care (yes vs no)
Time frame: During hospitalization, up to 30 days
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).
2 secondary outcomes
Oxygen Saturation
Time frame: Over a consecutive 24-hour period after randomization
Respiratory Effort as assessed by Respiratory Rate
Time frame: Over a consecutive 24-hour period after randomization
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 13 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Naresh Punjabi, MD principal investigator
Johns Hopkins University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone Positioning in people with Covid19 and Pneumonia, Viral, run by Johns Hopkins University at 4 sites 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 3 inclusion and 13 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 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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?
Occurrence of an escalation in respiratory related care (yes vs no) (time frame: During hospitalization, up to 30 days). 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 13 Jan 2022.