COVIDCO-Qo-ICUNCT04401111
One-year Outcomes in Survivors of the Severe COVID-19 Pneumonia (CO-Qo-ICU)
An observational study of COVID and ARDS, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Many of the patients hospitalized for a severe form of SARSCoV-2 respiratory impairment require prolonged intensive care that can be complicated in the short term, In the medium and long term, physical and psychological sequelae can affect patients' quality of life and prevent a return to normal working life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, ARDS, Quality of Life
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2020to Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients treated for COVID-19 in Intensive care unit
Who may be able to join
- Patients hospitalized in ICU for an ARDS table
- PCR SARSCoV-2 nasopharyngeal or positive pulmonary samples
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiparametric Evaluation of One-year Outcomes in Survivors of the Severe COVID-19 Pneumonia After Intensive Care Unit
Many of the patients hospitalized for a severe form of SARSCoV-2 respiratory impairment require prolonged intensive care that can be complicated in the short term, In the medium and long term, physical and psychological sequelae can affect patients' quality of life and prevent a return to normal working life.
To date, there is little data on the fate of patients treated in Resuscitation for a severe form of COVID-19, both in terms of respiratory sequelae, as well as in terms of psychological sequelae and their quality of life. The objective of this study is to be able to describe and evaluate the possible physical and psychological sequelae and quality of life of patients hospitalized in Resuscitation for a severe form of COVID-19 in the short (3 and 6 months), medium (1 year) and long (5 years) End of their stay in ICU. To do this, we want to carry out a prospective, observational and monocentric study in the consultation department of the Nice CHU. All patients admitted to Resuscitation for a severe form of COVID-19 who have accepted the longitudinal medical follow-up proposed by the Nice CHU will be included in the study and data from the computerized medical record will be analyzed.
- Conditions
- COVID, ARDS, Quality of Life
- Keywords
- Long term prognosis, Six-minute walk test, Restrictive syndrom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Survivors of Intensive care unit patients | Survivors of severe COVID-19 pneumonia after intensive care unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life assessment at 3 months of stay in ICU patients hospitalized for a severe form of COVID-19
SF-36 score calculation at 3 months of inpatient ICU stay for severe COVID-19
Measured: 5 years
Secondary outcomes (8)
Quality of Life Assessment at 6 months, 1 year and 5 years of Inpatient Resuscitation for severe COVID-19
Quality of Life Assessment at 6 months, 1 year and 5 years of Inpatient Resuscitation for severe COVID-19
Measured: 5 years
Assessment of respiratory function and lung lesions at 3 months, 6 months, 1 year and 5 years of hospitalized patients in ICU for severe COVID-19.
Vital and total lung capacity measurement when performing respiratory functional scans
Measured: 5 years
Stress-based assessment of respiratory function at 3 months, 6 months, 1 year and 5 years of hospitalized ICU for severe COVID-19
Measurement of the extent of pulmonary parenchymal lesions when performing a chest CT scan at 3 months, 6 months, 1 year and 5 years of hospitalized patients in ICU for severe COVID-19
Measured: 5 years
Assessment of resuscitation neuromyopathy at 3 months, 6 months, 1 year and 5 years of hospitalized patients in Resuscitation for severe COVID-19
Measurement of CKD score at 3 months, 6 months, 1 year and 5 years of hospitalized patient ICU for severe COVID-19. This score described in Appendix 2 is the recommended score for assessing resuscitation neuromyopathy
Measured: 5 years
Left and Right Cardiac Function Assessment at 3 months, 6 months, 1 year and 5 years of Inpatient Resuscitation for severe COVID-19
Measurement of left and right ventricular ejection fraction when performing a transthoracic cardiac ultrasound at 3 months, 6 months, 1 year and 5 years of hospitalized ICU for a severe form of COVID-19
Measured: 5 years
Psychological evaluation at 3 months, 6 months, 1 year and 5 years of stay in Intensive Care for patients hospitalized for a serious form of COVID-19
Evaluation des scores IES-R (Impact of Event Scale Revised) et HAD (Hospital Anxiety and Depression scale)
Measured: 5 years
Evaluation of the possible impact on professional activity at 3 months, 6 months, 1 year and 5 years of stay in Intensive Care for patients hospitalized for a serious form of COVID-19
Measure the return to work rate (full-time, half-time, <half-time, none) at 3 months, 6 months, 1 year and 5 years of hospitalized Resuscitation for severe COVID-19.
Measured: 5 years
Assessment of the 3-month, 6-month, 1-year and 5-year hospitalization rate for hospitalized patients with severe COVID-19.
The number of hospitalizations and the number of days spent in hospital at 3 months, 6 months, 1 year and 5 years of hospitalized patients in ICU for severe COVID-19.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start16 Jun 2020
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401111
- Sponsor's protocol ID
- 20reamedcovid04
- Acronym
- CO-Qo-ICU
- Status last verified
- May 2026
- First submitted
- 22 May 2020
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Data sharing plan has been established
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Evaluation of One-year Outcomes in Survivors of the Severe COVID-19 Pneumonia After Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04401111
- Acronym / sponsor ID
- CO-Qo-ICU / 20reamedcovid04
- Conditions
- COVID, ARDS, Quality of Life
- Keywords
- Long term prognosis, Six-minute walk test, Restrictive syndrom
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 26 May 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.
Many of the patients hospitalized for a severe form of SARSCoV-2 respiratory impairment require prolonged intensive care that can be complicated in the short term, In the medium and long term, physical and psychological sequelae can affect patients' quality of life and prevent a return to normal working life.
To date, there is little data on the fate of patients treated in Resuscitation for a severe form of COVID-19, both in terms of respiratory sequelae, as well as in terms of psychological sequelae and their quality of life. The objective of this study is to be able to describe and evaluate the possible physical and psychological sequelae and quality of life of patients hospitalized in Resuscitation for a severe form of COVID-19 in the short (3 and 6 months), medium (1 year) and long (5 years) End of their stay in ICU. To do this, we want to carry out a prospective, observational and monocentric study in the consultation department of the Nice CHU. All patients admitted to Resuscitation for a severe form of COVID-19 who have accepted the longitudinal medical follow-up proposed by the Nice CHU will be included in the study and data from the computerized medical record will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survivors of Intensive care unit patients | – | –Survivors of severe COVID-19 pneumonia after intensive care unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients treated for COVID-19 in Intensive care unit
Key inclusion criteria (2 listed)
- Patients hospitalized in ICU for an ARDS table
- PCR SARSCoV-2 nasopharyngeal or positive pulmonary samples
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life assessment at 3 months of stay in ICU patients hospitalized for a severe form of COVID-19
Time frame: 5 years
SF-36 score calculation at 3 months of inpatient ICU stay for severe COVID-19
8 secondary outcomes
Quality of Life Assessment at 6 months, 1 year and 5 years of Inpatient Resuscitation for severe COVID-19
Time frame: 5 years
Assessment of respiratory function and lung lesions at 3 months, 6 months, 1 year and 5 years of hospitalized patients in ICU for severe COVID-19.
Time frame: 5 years
Stress-based assessment of respiratory function at 3 months, 6 months, 1 year and 5 years of hospitalized ICU for severe COVID-19
Time frame: 5 years
Assessment of resuscitation neuromyopathy at 3 months, 6 months, 1 year and 5 years of hospitalized patients in Resuscitation for severe COVID-19
Time frame: 5 years
Left and Right Cardiac Function Assessment at 3 months, 6 months, 1 year and 5 years of Inpatient Resuscitation for severe COVID-19
Time frame: 5 years
Psychological evaluation at 3 months, 6 months, 1 year and 5 years of stay in Intensive Care for patients hospitalized for a serious form of COVID-19
Time frame: 5 years
Evaluation of the possible impact on professional activity at 3 months, 6 months, 1 year and 5 years of stay in Intensive Care for patients hospitalized for a serious form of COVID-19
Time frame: 5 years
Assessment of the 3-month, 6-month, 1-year and 5-year hospitalization rate for hospitalized patients with severe COVID-19.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No. No Data sharing plan has been established
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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 COVID and ARDS, run by Centre Hospitalier Universitaire de Nice 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 2 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 26 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?
This study is still under way. Results are not available in the source record yet.
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?
Quality of life assessment at 3 months of stay in ICU patients hospitalized for a severe form of COVID-19 (time frame: 5 years). 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 26 May 2026.