SARS-CoV 2 PneumoniaLong-termAPPNCT06080737
Long Term Effects of Awake Prone Positioning in COVID-19 ICU Patients
An observational study of SARS-CoV 2 Pneumonia, run by University Hospital, Tours at 1 site in France.
Trial summary
Long term follow up of patients included in a randomized controlled trial evaluating awake prone positioning among patients suffering SARS-CoV2 pneumonia (NCT04358939) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV 2 Pneumonia
- What is being tested?
- quality of life questionnaire
- How many people
- 137 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2024to 11 Nov 2024
- Phase
- Observational
- 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
Study population: Patients included in France in the randomized study "High Prone Covid" alive at day 28 (NCT04358939).
Who may be able to join
- Patients included in the randomized meta-trial evaluating awake prone position versus control among COVID-19 patients on high-flow nasal oxygen therapy (Ehrmann 2021).
- Patients alive at D28
- No opposition to participate in the research which evaluates mortality and quality of life by telephone interview.
Who cannot join
- Patients lost to follow-up after 28 days.
- Withdrawal of consent from randomized meta-trial by patient
- Vulnerable person: safeguard of justice, curatorship, or guardianship
- Patients refusing to answer telephone questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Awake Prone Positioning on Long-term Quality of Life in Patients Managed in the ICU Under Nasal High Flow for SARS-CoV2 Pneumonia, a Cohort Study Nested Within a Randomized Trial
Long term follow up of patients included in a randomized controlled trial evaluating awake prone positioning among patients suffering SARS-CoV2 pneumonia (NCT04358939)
Read the detailed description
All patients included in the initial trial who survived and were not lost to follow up at 28 days will be invited for a telephone interview to collect data on long term quality of life.
- Conditions
- SARS-CoV 2 Pneumonia
- Being tested
- quality of life questionnaire
- Keywords
- long-term quality of life, awake prone positioning, acute respiratory distress syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of life questionnaireOther
telephone interview to assess mortality and quality of life in the population included in a trial
| Study group | Role | What they receive |
|---|---|---|
| standard oxygen group | telephone interview comprising a quality of life questionnaire Receives: Other: quality of life questionnaire | |
| awake prone group | telephone interview comprising a quality of life questionnaire Receives: Other: quality of life questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
EURO QoL 5D 5L quality-of-life score
Quality of life at last follow-up, beyond 2 years after randomization, assessed by a EURO QoL 5D 5L quality-of-life score
Measured: 2 years after randomization
Secondary outcomes (11)
Mortality at last follow-up time beyond 2 years after randomization
Measured: an average of 2 years follow up
Assessment of autonomy
Subpart of EURO QoL 5D 5L score
Measured: an average of 2 years follow up
Assessment of mobility
Subpart of EURO QoL 5D 5L score
Measured: an average of 2 years follow up
Assessment of performance of daily activities
Subpart of EURO QoL 5D 5L score
Measured: an average of 2 years follow up
Assessment of pain and discomfort
Subpart of EURO QoL 5D 5L score
Measured: an average of 2 years follow up
Assessment of anxiety and depression
Subpart of EURO QoL 5D 5L score
Measured: an average of 2 years follow up
Number of points on the visual analog scale
Subpart of EURO QoL 5D 5L score
Measured: an average of 2 years follow up
Hospitalisations
Number of new hospitalizations during follow-up period
Measured: an average of 2 years follow up
Family situation
Change of family situation
Measured: before hospitalization in intensive care unit, then at 12, 24 months and at final follow-up.
Employment status
Change of employment status
Measured: before hospitalization, then at 12, 24 months and at final follow-up.
Subgroup analysis:
analysis of primary endpoint, mortality, and subparts of the EURO QoL 5D 5L score in subgroups of patients who were intubated or not during follow-up in the initial meta-assay
Measured: an average of 2 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start3 May 2024
- Primary completion11 Nov 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV 2 PneumoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080737
- Sponsor's protocol ID
- DR 230170 - Long-term APP
- Acronym
- Long-termAPP
- Status last verified
- Apr 2026
- First submitted
- 10 Oct 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Awake Prone Positioning on Long-term Quality of Life in Patients Managed in the ICU Under Nasal High Flow for SARS-CoV2 Pneumonia, a Cohort Study Nested Within a Randomized Trial
- ClinicalTrials.gov ID
- NCT06080737
- Acronym / sponsor ID
- Long-termAPP / DR 230170 - Long-term APP
- Conditions
- SARS-CoV 2 Pneumonia
- Keywords
- long-term quality of life, awake prone positioning, acute respiratory distress syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 12 Oct 2023 (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.
Long term follow up of patients included in a randomized controlled trial evaluating awake prone positioning among patients suffering SARS-CoV2 pneumonia (NCT04358939)
Detailed description
All patients included in the initial trial who survived and were not lost to follow up at 28 days will be invited for a telephone interview to collect data on long term quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard oxygen group | – | Other: quality of life questionnairetelephone interview comprising a quality of life questionnaire |
| awake prone group | – | Other: quality of life questionnairetelephone interview comprising a quality of life questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included in France in the randomized study "High Prone Covid" alive at day 28 (NCT04358939).
Key inclusion criteria (3 listed)
- Patients included in the randomized meta-trial evaluating awake prone position versus control among COVID-19 patients on high-flow nasal oxygen therapy (Ehrmann 2021).
- Patients alive at D28
- No opposition to participate in the research which evaluates mortality and quality of life by telephone interview.
Key exclusion criteria (4 listed)
- Patients lost to follow-up after 28 days.
- Withdrawal of consent from randomized meta-trial by patient
- Vulnerable person: safeguard of justice, curatorship, or guardianship
- Patients refusing to answer telephone questionnaire.
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 |
|---|---|---|
| quality of life questionnairetelephone interview to assess mortality and quality of life in the population included in a trial | Other | awake prone group, standard oxygen group |
Primary outcome
EURO QoL 5D 5L quality-of-life score
Time frame: 2 years after randomization
Quality of life at last follow-up, beyond 2 years after randomization, assessed by a EURO QoL 5D 5L quality-of-life score
11 secondary outcomes
Mortality at last follow-up time beyond 2 years after randomization
Time frame: an average of 2 years follow up
Assessment of autonomy
Time frame: an average of 2 years follow up
Assessment of mobility
Time frame: an average of 2 years follow up
Assessment of performance of daily activities
Time frame: an average of 2 years follow up
Assessment of pain and discomfort
Time frame: an average of 2 years follow up
Assessment of anxiety and depression
Time frame: an average of 2 years follow up
Number of points on the visual analog scale
Time frame: an average of 2 years follow up
Hospitalisations
Time frame: an average of 2 years follow up
Family situation
Time frame: before hospitalization in intensive care unit, then at 12, 24 months and at final follow-up.
Employment status
Time frame: before hospitalization, then at 12, 24 months and at final follow-up.
Subgroup analysis:
Time frame: an average of 2 years follow up
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 4 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV 2 Pneumonia, run by University Hospital, Tours at 1 site in France.
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 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 4 May 2026. 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 France. 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?
EURO QoL 5D 5L quality-of-life score (time frame: 2 years after randomization). 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 4 May 2026.