COVID-19NCT05083130
Awake Prone Positioning in Moderate to Severe COVID-19
A study testing a wake prone positioning in people with COVID-19 and SARS-CoV2 Infection, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
Trial summary
The purpose of this study is comparing vital signs between standard care and prone position groups. Standard care will consist of routine clinical care, including any advice to lie in prone position as routinely recommended by participating sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV2 Infection, COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- a wake prone positioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteVietnam
- Study dates
- 8 Mar 2022to 1 May 2023
- 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
- Probable or confirmed COVID-19 infection according to WHO criteria
- Moderate or severe COVID-19 respiratory infection according to Vietnamese guidelines
- Requirement for supplemental oxygen therapy
Who cannot join
- Invasive mechanical ventilation, or non-invasive ventilation (NIV) with CPAP or BiPAP or imminent need for these
- Contraindications to prone position (see Appendix 5)
- Pregnancy
- Severe obesity (BMI >35),
- Altered level of consciousness (GCS <13)
- Attending doctor judged prone position to be unsuitable for the patient for any reason
- Patients in whom there is a decision that care will not be escalated
- Failure to have informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Awake Prone Positioning Effectiveness in Moderate to Severe COVID-19
The purpose of this study is comparing vital signs between standard care and prone position groups. Standard care will consist of routine clinical care, including any advice to lie in prone position as routinely recommended by participating sites. For those randomized to prone position, a special intervention team will visit patients' rooms aiming for patients to maintain the prone position for at least 8 hours a day.
Read the detailed description
This study is a pragmatic open label randomised controlled trial. After being informed about the study and potential risks, all patients having written informed consents will be randomised into two groups. Standard care group will consist of routine clinical care, including any advice to lie in prone position as routinely recommended by participating sites. To reduce bias, the study team will make visits at a similar schedule to those to patients in the intervention group, however these visits will be confined to general advice and measurement of vital signs. Patients will receive written advice more general in nature about COVID-19 disease. For those randomized to prone position group, a special intervention team will visit patients' rooms aiming for patients to maintain the prone position for at least 8 hours a day. The team will give written and verbal advice and if necessary aid patients' positioning themselves in the prone position. The exact duration of prone sessions will be determined according to ward schedules to take account of nursing procedures, meal times and mitigation strategies. Other methods to encourage the maintenance of prone position includes phone calls to patients, carers or education of carers. Compliance with the intervention will be evaluated by observation (manual and using in-room cameras) at fixed time intervals. In a subgroup of 100 patients accelerometer/gyrometer devices will be used to measure movement and position (this will be expanded to all patients if equipment is available). Other outcome measures (SpO2, heart rate etc) will be measured using standard monitoring equipment currently used at study sites, including wearable devices.
- Conditions
- COVID-19, SARS-CoV2 Infection, COVID-19 Acute Respiratory Distress Syndrome, Acute Hypoxemic Respiratory Failure, Respiratory Distress Syndrome, Adult
- Being tested
- a wake prone positioning
- Keywords
- prone position, severe COVID-19, acute respiratory distress syndrome (ARDS), Vietnam
- Medical subject headings
- COVID-19, Respiratory Insufficiency, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a wake prone positioningBehavioural
The team will give written and verbal advice and if necessary aid patients' positioning themselves in the prone position for at least 8 hours per day. The exact duration of prone sessions will be determined according to ward schedules to take account of nursing procedures, meal times and mitigation strategies. Other methods to encourage the maintenance of prone position includes phone calls to patients, carers or education of carers.
| Study group | Role | What they receive |
|---|---|---|
| standard care | No intervention | Standard care will consist of routine clinical care, including any advice to lie in prone position as routinely recommended by participating sites |
| prone position | Experimental | prone position group will have a special intervention team who visits patients' rooms aiming for patients to maintain the prone position for at least 8 hours a day Receives: Behavioral: a wake prone positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who require escalation of respiratory therapy
Escalation of respiratory therapy within 28 days of randomization, defined as any of the following:
- Escalation to next level respiratory support (with lowest level nasal cannula or face mask, escalating through HFNC to NIV or mechanical ventilation).
- Intubation
Measured: Up to 28 days after enrollment
Secondary outcomes (4)
Fatal event
all-cause of death within first 28 days will be compared between groups
Measured: Up to 28 days after enrollment
Duration of hospital stay
Days since admission to discharge
Measured: Up to 2 months after enrollment
Improvement in oxygen related parameters
SpO2, respiratory rate, heart rate, FiO2, ROX index will be documented before and at end of period of prone positioning every day. The improvement will be measured by resolution of them compared with baseline parameters
Measured: Up to 28 days after enrollment
Number of adverse events
An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. The severity of all AEs in this trial should be graded in line with the toxicity grading in Toxicity grading and management (CTCAE)
Measured: Up to 28 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start8 Mar 2022
- Primary completion31 Mar 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label randomised controlled trial comparing standard care to prone position
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
- Responsible party
- Sponsor
- Investigators
- Louise C Thwaites, MD. PhD., Principal investigator, University of Oxford, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083130
- Sponsor's protocol ID
- 06NV
- Status last verified
- Jun 2023
- First submitted
- 10 Oct 2021
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data of this study may be requested for publication by journals. Sharing anonymised data with future similar/suitable studies will be decided by the sponsor, PIs and the authority agency where the data was collected. No identifiable information will be shared with any other person/organisation
Publications
Dondorp AM, Hayat M, Aryal D, Beane A, Schultz MJ. Respiratory Support in COVID-19 Patients, with a Focus on Resource-Limited Settings. Am J Trop Med Hyg. 2020 Jun;102(6):1191-1197. doi: 10.4269/ajtmh.20-0283.
PubMed 32319424Gonzalez-Seguel F, Pinto-Concha JJ, Aranis N, Leppe J. Adverse Events of Prone Positioning in Mechanically Ventilated Adults With ARDS. Respir Care. 2021 Dec;66(12):1898-1911. doi: 10.4187/respcare.09194. Epub 2021 Jul 23.
PubMed 34301802Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone Positioning Meta-Trial Group. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med. 2021 Dec;9(12):1387-1395. doi: 10.1016/S2213-2600(21)00356-8. Epub 2021 Aug 20.
PubMed 34425070Phong NT, Duc DH, Hai HB, Nguyen NT, Khoa LDV, Khanh LTT, Tran LHB, Linh NTM, Van CTC, Thao DP, Trinh NTD, Kieu PT, Truong NT, Hoang VT, Ngoc NT, Vien TTD, Ly VT, Khoa TD, Beane A, Anibal J; OUCRU COVID RESEACH GROUP; Thwaites GE, Geskus R, Clifton D, Dung NTP, Kestelyn E, Glover G, Tan LV, Yen LM, Tung NLN, Dung NT, Thwaites CL. Awake prone positioning effectiveness in moderate to severe COVID-19 a randomized controlled trial. Wellcome Open Res. 2024 Dec 7;9:543. doi: 10.12688/wellcomeopenres.22792.2. eCollection 2024.
PubMed 39654551
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Awake Prone Positioning Effectiveness in Moderate to Severe COVID-19
- ClinicalTrials.gov ID
- NCT05083130
- Acronym / sponsor ID
- 06NV
- Conditions
- COVID-19, SARS-CoV2 Infection, COVID-19 Acute Respiratory Distress Syndrome, Acute Hypoxemic Respiratory Failure, Respiratory Distress Syndrome, Adult
- Keywords
- prone position, severe COVID-19, acute respiratory distress syndrome (ARDS), Vietnam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Oxford University Clinical Research Unit, VietnamUniversity, hospital or other
- Collaborators
- Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 19 Oct 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 purpose of this study is comparing vital signs between standard care and prone position groups. Standard care will consist of routine clinical care, including any advice to lie in prone position as routinely recommended by participating sites. For those randomized to prone position, a special intervention team will visit patients' rooms aiming for patients to maintain the prone position for at least 8 hours a day.
Detailed description
This study is a pragmatic open label randomised controlled trial. After being informed about the study and potential risks, all patients having written informed consents will be randomised into two groups. Standard care group will consist of routine clinical care, including any advice to lie in prone position as routinely recommended by participating sites. To reduce bias, the study team will make visits at a similar schedule to those to patients in the intervention group, however these visits will be confined to general advice and measurement of vital signs. Patients will receive written advice more general in nature about COVID-19 disease. For those randomized to prone position group, a special intervention team will visit patients' rooms aiming for patients to maintain the prone position for at least 8 hours a day. The team will give written and verbal advice and if necessary aid patients' positioning themselves in the prone position. The exact duration of prone sessions will be determined according to ward schedules to take account of nursing procedures, meal times and mitigation strategies. Other methods to encourage the maintenance of prone position includes phone calls to patients, carers or education of carers. Compliance with the intervention will be evaluated by observation (manual and using in-room cameras) at fixed time intervals. In a subgroup of 100 patients accelerometer/gyrometer devices will be used to measure movement and position (this will be expanded to all patients if equipment is available). Other outcome measures (SpO2, heart rate etc) will be measured using standard monitoring equipment currently used at study sites, including wearable devices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label randomised controlled trial comparing standard care to prone position
| Arm | Type | Receives |
|---|---|---|
| standard care | No intervention | –Standard care will consist of routine clinical care, including any advice to lie in prone position as routinely recommended by participating sites |
| prone position | Experimental | Behavioral: a wake prone positioningprone position group will have a special intervention team who visits patients' rooms aiming for patients to maintain the prone position for at least 8 hours a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Probable or confirmed COVID-19 infection according to WHO criteria
- Moderate or severe COVID-19 respiratory infection according to Vietnamese guidelines
- Requirement for supplemental oxygen therapy
Key exclusion criteria (8 listed)
- Invasive mechanical ventilation, or non-invasive ventilation (NIV) with CPAP or BiPAP or imminent need for these
- Contraindications to prone position (see Appendix 5)
- Pregnancy
- Severe obesity (BMI >35),
- Altered level of consciousness (GCS <13)
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 |
|---|---|---|
| a wake prone positioningThe team will give written and verbal advice and if necessary aid patients' positioning themselves in the prone position for at least 8 hours per day. The exact duration of prone sessions will be determined according to ward schedules to take account of nursing procedures, meal times and mitigation strategies. Other methods to encourage the maintenance of prone position includes phone calls to patients, carers or education of carers. | Behavioural | prone position |
Primary outcome
Percentage of participants who require escalation of respiratory therapy
Time frame: Up to 28 days after enrollment
Escalation of respiratory therapy within 28 days of randomization, defined as any of the following: * Escalation to next level respiratory support (with lowest level nasal cannula or face mask, escalating through HFNC to NIV or mechanical ventilation). * Intubation
4 secondary outcomes
Fatal event
Time frame: Up to 28 days after enrollment
Duration of hospital stay
Time frame: Up to 2 months after enrollment
Improvement in oxygen related parameters
Time frame: Up to 28 days after enrollment
Number of adverse events
Time frame: Up to 28 days after enrollment
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 7 Jun 2023.
- Background: PubMed 32319424Dondorp AM, Hayat M, Aryal D, Beane A, Schultz MJ. Respiratory Support in COVID-19 Patients, with a Focus on Resource-Limited Settings. Am J Trop Med Hyg. 2020 Jun;102(6):1191-1197. doi: 10.4269/ajtmh.20-0283.
- Background: PubMed 34301802Gonzalez-Seguel F, Pinto-Concha JJ, Aranis N, Leppe J. Adverse Events of Prone Positioning in Mechanically Ventilated Adults With ARDS. Respir Care. 2021 Dec;66(12):1898-1911. doi: 10.4187/respcare.09194. Epub 2021 Jul 23.
- Background: PubMed 34425070Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone Positioning Meta-Trial Group. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med. 2021 Dec;9(12):1387-1395. doi: 10.1016/S2213-2600(21)00356-8. Epub 2021 Aug 20.
- Derived from this study: PubMed 39654551Phong NT, Duc DH, Hai HB, Nguyen NT, Khoa LDV, Khanh LTT, Tran LHB, Linh NTM, Van CTC, Thao DP, Trinh NTD, Kieu PT, Truong NT, Hoang VT, Ngoc NT, Vien TTD, Ly VT, Khoa TD, Beane A, Anibal J; OUCRU COVID RESEACH GROUP; Thwaites GE, Geskus R, Clifton D, Dung NTP, Kestelyn E, Glover G, Tan LV, Yen LM, Tung NLN, Dung NT, Thwaites CL. Awake prone positioning effectiveness in moderate to severe COVID-19 a randomized controlled trial. Wellcome Open Res. 2024 Dec 7;9:543. doi: 10.12688/wellcomeopenres.22792.2. eCollection 2024.
- Prone position in ARDS patients: why, when, how and for whom. Intensive Care Med \[Internet\]. 2020;46(12):2385-96.Link provided by the sponsor.
- Prone positioning in severe acute respiratory distress syndrome. N Engl J Med \[Internet\]. 2013 Jun 6 \[cited 2014 May 23\];368(23):2159-68Link provided by the sponsor.
- Vietnam Ministry of Health guideline on COVID-19 management, treatmentLink provided by the sponsor.
- Effect of awake prone position on diaphragmatic thickening fraction in patients assisted by noninvasive ventilation for hypoxemic acute respiratory failure related to novel coronLink provided by the sponsor.
- Effect of early awake prone positioning application on prognosis in patients with acute respiratory failure due to COVID-19 pneumonia: a retrospective observational study. Brazilian J AnestheLink provided by the sponsor.
- Expert consensus statements for the management of COVID-19-related acute respiratory failure using a Delphi method. Crit Care \[Internet\]Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymised data of this study may be requested for publication by journals. Sharing anonymised data with future similar/suitable studies will be decided by the sponsor, PIs and the authority agency where the data was collected. No identifiable information will be shared with any other person/organisation
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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.
Louise C Thwaites, MD. PhD. principal investigator
University of Oxford, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a wake prone positioning in people with COVID-19 and SARS-CoV2 Infection, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
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 8 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 7 Jun 2023. 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 Vietnam. 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?
Percentage of participants who require escalation of respiratory therapy (time frame: Up to 28 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05083130, which also lists 4 linked publications.
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 7 Jun 2023.