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CompletedNCT06080737Long-termAPPUpdated May 4, 2026

Long Term Effects of Awake Prone Positioning in COVID-19 ICU Patients

An observational study in SARS-CoV 2 Pneumonia, sponsored by University Hospital, Tours. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by University Hospital, Tours · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
137
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • SARS-CoV 2 Pneumonia

Keywords

  • long-term quality of life
  • awake prone positioning
  • acute respiratory distress syndrome
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 137 is above the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients included in France in the randomized study "High Prone Covid" alive at day 28 (NCT04358939).

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
137 participants (actual)
Patient registry
No

Groups and cohorts

  • standard oxygen group

    telephone interview comprising a quality of life questionnaire

    Other: quality of life questionnaire

  • awake prone group

    telephone interview comprising a quality of life questionnaire

    Other: quality of life questionnaire

Interventions

  • Otherquality of life questionnaire

    telephone interview to assess mortality and quality of life in the population included in a trial

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 years after randomization

Secondary outcomes

  1. Mortality at last follow-up time beyond 2 years after randomization

    Time frame: an average of 2 years follow up

  2. Assessment of autonomy

    Subpart of EURO QoL 5D 5L score

    Time frame: an average of 2 years follow up

  3. Assessment of mobility

    Subpart of EURO QoL 5D 5L score

    Time frame: an average of 2 years follow up

  4. Assessment of performance of daily activities

    Subpart of EURO QoL 5D 5L score

    Time frame: an average of 2 years follow up

  5. Assessment of pain and discomfort

    Subpart of EURO QoL 5D 5L score

    Time frame: an average of 2 years follow up

  6. Assessment of anxiety and depression

    Subpart of EURO QoL 5D 5L score

    Time frame: an average of 2 years follow up

  7. Number of points on the visual analog scale

    Subpart of EURO QoL 5D 5L score

    Time frame: an average of 2 years follow up

  8. Hospitalisations

    Number of new hospitalizations during follow-up period

    Time frame: an average of 2 years follow up

  9. Family situation

    Change of family situation

    Time frame: before hospitalization in intensive care unit, then at 12, 24 months and at final follow-up.

  10. Employment status

    Change of employment status

    Time frame: before hospitalization, then at 12, 24 months and at final follow-up.

  11. 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

    Time frame: an average of 2 years follow up

07

Study locations

1 site
  • university hospital Tours
    Tours, 37000, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06080737
Lead sponsor
University Hospital, Tours
Responsible party
Sponsor
First posted
Oct 12, 2023
Start date
May 3, 2024
Primary completion
Nov 11, 2024
Completion
Nov 11, 2024
Last update
May 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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