Patient Admitted to Intensive Care Unit for COVID-19TeleRea'nCoNCT04609839
FOLLOW-UP OF PATIENTS WITH COVID-19.
An observational study of Patient Admitted to Intensive Care Unit for COVID-19, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Some patients admitted to intensive care for a severe form of COVID-19 could have respiratory, cardiac, renal and neurological sequelae in the medium or long term. The results of this research will allow an improvement in the understanding and management of patients in the medium and long term. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Admitted to Intensive Care Unit for COVID-19
- What is being tested?
- Follow-up of patients with COVID-19
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2020to 17 Oct 2023
- 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: Patient admitted to intensive care unit for COVID-19.
Who may be able to join
- Patient admitted to intensive care unit for COVID-19
- Adult patient ≥ 18 years old
- Subject having expressed his non-opposition to the research
- Subject affiliated to a social health insurance protection scheme or beneficiary of such a scheme
Who cannot join
- Subject under safeguard of justice
- Patient under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TeleRea'nCo : FOLLOW-UP OF PATIENTS WITH COVID-19.
Some patients admitted to intensive care for a severe form of COVID-19 could have respiratory, cardiac, renal and neurological sequelae in the medium or long term.
The results of this research will allow an improvement in the understanding and management of patients in the medium and long term.
- Being tested
- Follow-up of patients with COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up of patients with COVID-19Other
The presence of sequelae, number of re-hospitalizations, date of death and cost of health expenditure will be collected.
The Quality of life score (SF-36 questionnaire) and the Pittsburgh sleep quality index (PSQI questionnaire) will be completed by patients.
| Study group | Role | What they receive |
|---|---|---|
| Patient admitted to intensive care unit for COVID-19 | Not described Receives: Other: Follow-up of patients with COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of respiratory, renal, cardiac, motor, neurological, and psychological sequelae will be assessed by specialist doctors during the 12 months following the patient's discharge from intensive care.
Measured: The primary endpoint will be measured during 12 months following the patient's discharge from intensive care.
Secondary outcomes (6)
1) The sequelae by type of impairment will be assessed by specialist doctors at 3, 6 and 12 months
Measured: At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion
2) Number of re-hospitalizations at 3, 6 and 12 months
Measured: At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion
3) Date of death
Measured: Date of death will be collected from inclusion to M12 (12 months after patient inclusion)
4.1) Quality of life score (SF-36 questionnaire) at 3, 6 and 12 months
Measured: At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion
4.2) The Pittsburgh sleep quality index (PSQI questionnaire) at 3, 6 and 12 months
Measured: At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion
5) Cost of health expenditure
Measured: The cost of health expenditure will be collected from inclusion to M12 (12 months after patient inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start15 Sep 2020
- Primary completion17 Oct 2023
- Study completion17 Oct 2023
Why it stopped: Patients were enrolled in another similar clinical study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Admitted to Intensive Care Unit for COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609839
- Sponsor's protocol ID
- TeleRea'nCo
- Other IDs
- 7883
- Acronym
- TeleRea'nCo
- Status last verified
- Sep 2025
- First submitted
- 26 Oct 2020
- Last updated
- 16 Sep 2025
- 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 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TeleRea'nCo : FOLLOW-UP OF PATIENTS WITH COVID-19.
- ClinicalTrials.gov ID
- NCT04609839
- Acronym / sponsor ID
- TeleRea'nCo / TeleRea'nCo
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Patients were enrolled in another similar clinical study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 30 Oct 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.
Some patients admitted to intensive care for a severe form of COVID-19 could have respiratory, cardiac, renal and neurological sequelae in the medium or long term.
The results of this research will allow an improvement in the understanding and management of patients in the medium and long term.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient admitted to intensive care unit for COVID-19 | – | Other: Follow-up of patients with COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted to intensive care unit for COVID-19.
Key inclusion criteria (4 listed)
- Patient admitted to intensive care unit for COVID-19
- Adult patient ≥ 18 years old
- Subject having expressed his non-opposition to the research
- Subject affiliated to a social health insurance protection scheme or beneficiary of such a scheme
Key exclusion criteria (2 listed)
- Subject under safeguard of justice
- Patient under guardianship or curatorship
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 |
|---|---|---|
| Follow-up of patients with COVID-19The presence of sequelae, number of re-hospitalizations, date of death and cost of health expenditure will be collected. The Quality of life score (SF-36 questionnaire) and the Pittsburgh sleep quality index (PSQI questionnaire) will be completed by patients. | Other | Patient admitted to intensive care unit for COVID-19 |
Primary outcome
The presence of respiratory, renal, cardiac, motor, neurological, and psychological sequelae will be assessed by specialist doctors during the 12 months following the patient's discharge from intensive care.
Time frame: The primary endpoint will be measured during 12 months following the patient's discharge from intensive care.
6 secondary outcomes
1) The sequelae by type of impairment will be assessed by specialist doctors at 3, 6 and 12 months
Time frame: At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion
2) Number of re-hospitalizations at 3, 6 and 12 months
Time frame: At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion
3) Date of death
Time frame: Date of death will be collected from inclusion to M12 (12 months after patient inclusion)
4.1) Quality of life score (SF-36 questionnaire) at 3, 6 and 12 months
Time frame: At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion
4.2) The Pittsburgh sleep quality index (PSQI questionnaire) at 3, 6 and 12 months
Time frame: At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion
5) Cost of health expenditure
Time frame: The cost of health expenditure will be collected from inclusion to M12 (12 months after patient inclusion)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- 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.
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 Patient Admitted to Intensive Care Unit for COVID-19, run by University Hospital, Strasbourg, France 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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 16 Sep 2025. 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 was withdrawn before enrolling participants, so there are no results.
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?
The presence of respiratory, renal, cardiac, motor, neurological, and psychological sequelae will be assessed by specialist doctors during the 12 months following the patient's discharge from intensive care. (time frame: The primary endpoint will be measured during 12 months following the patient's discharge from intensive care.). 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 16 Sep 2025.